ID

4502

Description

The purpose of this Phase 2 clinical research study is to examine the safety of an experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of new blood vessels from existing blood vessels (a process called angiogenesis) in an attempt to improve the flow of blood in the legs of patients with peripheral arterial disease (PAD). Specifically, this study will enroll patients with severe intermittent claudication (IC) which is the stage of PAD in which a patient's walking ability is severely limited, causing pain in the legs upon exercise due to inadequate blood flow to the muscles of the lower limbs.

Keywords

Clinical Trial

Eligibility Determination

Intermittent Claudication

12/9/13 12/9/13 - Martin Dugas

Uploaded on

December 9, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00117650 # Intermittent Claudication

model
Details

Eligibility

1 forms

StudyEvent: Eligibility
1. Eligibility

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Inclusion criteria

Item Group

Inclusion criteria

Healthy Volunteers

Item

No Healthy Volunteers

boolean

C1708335 (UMLS CUI)

InclusionCriterion_1

Item

Males and females 40 to 80 years of age, inclusive.

boolean

C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LNC)
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)

InclusionCriterion_2

Item

Clinical diagnosis of PAD, secondary to atherosclerosis, in both lower limbs, confirmed by objective evidence: An ankle-brachial index (ABI) of ≤ 0.90 at rest in at least 1 lower limb (Note: The index limb must be ≤ 0.90 at rest.); The ABI after exercise must be reduced by ≥ 20% from the ABI at rest in the index leg (the most symptomatic leg during the treadmill testing). The post-exercise ABI will also be performed on the other leg if the resting ABI > 0.90. A patient may be eligible for the study with a resting ABI in the non-index limb > 0.90 if: a. The post-exercise ABI in the non-index leg is also reduced by greater than or equal to 20% OR; b. A medically significant stenosis (defined as ≥ 50%) of a femoropopliteal or infrapopliteal artery is present, as documented via an imaging study (such as MR, conventional angiography, duplex ultrasound, or CT); If the ABI cannot be measured in either leg (due to non-compressible arteries), then a toe-brachial index (TBI) of ≤ 0.70 may be used in its place to confirm PAD.

boolean

C1704436 (UMLS CUI)
067825 (MDR)
399957001 (SNOMED CT 2010_0731)
C0004153 (UMLS CUI)
I70 (ICD10CM)
440 (ICD9CM)
10003601 (MDR)
38716007 (SNOMED CT 2010_0731)
C0023216 (UMLS CUI)
MTHU011970 (LNC)
61685007 (SNOMED CT 2010_0731)
C1328319 (UMLS CUI)
10062762 (MDR)
C0087110 (UMLS CUI)
10044555 (MDR)
C2721556 (UMLS CUI)
10069344 (MDR)
C0447110 (UMLS CUI)
244336000 (SNOMED CT 2010_0731)
C1261287 (UMLS CUI)
C1881134 (UMLS CUI)
MTHU029412 (LNC)
C2116889 (UMLS CUI)

InclusionCriterion_3

Item

Symptoms of severe intermittent claudication (IC) in at least 1 lower limb persisting for ≥ 6 months

boolean

C0021775 (UMLS CUI)
I73.9 (ICD10CM)
10022562 (MDR)
63491006 (SNOMED CT 2010_0731)
C0023216 (UMLS CUI)
MTHU011970 (LNC)
61685007 (SNOMED CT 2010_0731)

InclusionCriterion_4

Item

Patients with a peak walking time (PWT) of 1 to 12 minutes (inclusive) using the standardized exercise treadmill test at each of the 2 consecutive treadmill tests performed at least a week apart during the Screening period.

boolean

C0430506 (UMLS CUI)
302761001 (SNOMED CT 2010_0731)
C0087110 (UMLS CUI)
10044555 (MDR)

InclusionCriterion_5

Item

During Screening, patients must demonstrate consistency of PWTs between 2 standardized exercise treadmill tests (Walk 1 and Walk 2) performed at least 1 week apart.

boolean

C0430506 (UMLS CUI)
302761001 (SNOMED CT 2010_0731)
C0087110 (UMLS CUI)
10044555 (MDR)

InclusionCriterion_6

Item

Consistency of the PWT between the 2 visits is achieved if the difference between PWT at Walk 1 and Walk 2 is ≤ 25% of the higher of the 2 PWTs ([higher PWT - lower PWT]/higher PWT).

boolean

C0430506 (UMLS CUI)
302761001 (SNOMED CT 2010_0731)

InclusionCriterion_7

Item

If the difference between PWT at Walk 1 and Walk 2 is > 25% of the higher of the 2 PWTs, a third treadmill test (Walk 3) may be performed at the discretion of the Principal Investigator between 7 and 14 days following Walk 2. The variability in PWT warranting the performance of Walk 3 must be secondary to circumstances that may contribute to the observed variation (e.g., prior exertion, inconsistent timing, ingestion of a meal within 4 hours, etc). To qualify for the study, the difference between PWT of either Walk 1 or Walk 2 as compared with Walk 3 must be ≤ 25% of the higher of the 2 PWTs ([higher PWT - lower PWT]/higher PWT). The decision whether Walk 1 or Walk 2 will be used for comparison with Walk 3 will be made prospectively and reviewed with the Sponsor.

boolean

C0430506 (UMLS CUI)
302761001 (SNOMED CT 2010_0731)
CL102947 (UMLS CUI)

InclusionCriterion_8

Item

An acceptable mean PWT must be achieved within 4 weeks of treatment administration.

boolean

C0430506 (UMLS CUI)
302761001 (SNOMED CT 2010_0731)

InclusionCriterion_9

Item

Patients have been considered for other potential treatment options including exercise rehabilitation, smoking cessation, and pharmacological therapy prior to Enrollment.

boolean

C1631603 (UMLS CUI)
419733004 (SNOMED CT 2010_0731)
C0683525 (UMLS CUI)
C1516879 (UMLS CUI)

InclusionCriterion_10

Item

Claudication severity, concomitant medications for the treatment of CAD, PAD, and IC, smoking status and exercise habits should be clinically stable for 3 months prior to Enrollment.

boolean

C0021775 (UMLS CUI)
I73.9 (ICD10CM)
10022562 (MDR)
63491006 (SNOMED CT 2010_0731)
C0439793 (UMLS CUI)
246112005 (SNOMED CT 2010_0731)
C2826666 (UMLS CUI)
C0010068 (UMLS CUI)
I25.1 (ICD10CM)
10068617 (MDR)
53741008 (SNOMED CT 2010_0731)
C1704436 (UMLS CUI)
067825 (MDR)
399957001 (SNOMED CT 2010_0731)
C1519386 (UMLS CUI)
C0015259 (UMLS CUI)
10015634 (MDR)
183301007 (SNOMED CT 2010_0731)
C0205360 (UMLS CUI)
MTHU015276 (LNC)
58158008 (SNOMED CT 2010_0731)
C1516879 (UMLS CUI)

InclusionCriterion_11

Item

Patients who are committed to following the protocol requirements as evidenced by written informed consent.

boolean

C0021430 (UMLS CUI)

Exclusion criteria

Item Group

Exclusion criteria

ExclusionCriterion_1

Item

Patients with either current or any history of Critical Limb Ischemia (CLI; that is, patients classified as Rutherford Category 4 [ischemic rest pain], Rutherford Category 5 [non-healing ischemic ulcers and minor tissue loss], or Rutherford Category 6 [non-healing ischemic ulcers and major tissue loss]).

boolean

C1142264 (UMLS CUI)
10058072 (MDR)

ExclusionCriterion_2

Item

Patients in whom arterial insufficiency in the lower extremity is the result of acute limb ischemia or an immunological or inflammatory non-atherosclerotic disorder (eg, thromboangiitis obliterans [Buerger's Disease]) and systemic sclerosis [both limited and diffuse forms]).

boolean

C0340565 (UMLS CUI)
233961000 (SNOMED CT 2010_0731)
C0021053 (UMLS CUI)
D89.9 (ICD10CM)
279 (ICD9CM)
10021425 (MDR)
41266007 (SNOMED CT 2010_0731)
C1290884 (UMLS CUI)
128139000 (SNOMED CT 2010_0731)
C0040021 (UMLS CUI)
I73.1 (ICD10CM)
443.1 (ICD9CM)
10043540 (MDR)
52403007 (SNOMED CT 2010_0731)
C0036421 (UMLS CUI)
M34.0 (ICD10CM)
710.1 (ICD9CM)
10042953 (MDR)
89155008 (SNOMED CT 2010_0731)

ExclusionCriterion_3

Item

A PAD-specific surgical revascularization procedure within 6 months of enrollment or a PAD-specific percutaneous procedure within 3 months of enrollment, or patients likely to require a PAD-specific revascularization procedure within 6 months after Enrollment.

boolean

C0472670 (UMLS CUI)
233505002 (SNOMED CT 2010_0731)
C1516879 (UMLS CUI)

ExclusionCriterion_4

Item

Patients with aortoiliac disease that limits inflow in either leg: a. Patients with concomitant aortoiliac disease (i.e., patients with a significant component of inflow disease in the distal aorta, common or external iliac, or proximal common femoral artery) as assessed by an imaging modality (e.g., segmental limb pressures and waveform analysis, duplex ultrasound scanning, magnetic resonance angiography, or radio-contrast arteriogram) performed within 1 year prior to Enrollment. If subject has had a bypass after the imaging study, then documentation of graft patency is required within 6 months prior to Enrollment; b. If it is suspected at Screening that a patient has aortoiliac disease based on vascular examination, an imaging modality (e.g., segmental limb pressures and waveform analysis, duplex ultrasound scanning, magnetic resonance angiography, or radio-contrast arteriogram) must be performed to rule it out if there is not one available within the times specified above. If there is no suspicion of aortoiliac disease in the Principal Investigator's judgment, an imaging test at Screening is not required for study purposes.

boolean

C0729733 (UMLS CUI)
233956002 (SNOMED CT 2010_0731)
C1881134 (UMLS CUI)
MTHU029412 (LNC)
C1516879 (UMLS CUI)
C0741847 (UMLS CUI)
88834003 (SNOMED CT 2010_0731)
CL102947 (UMLS CUI)

ExclusionCriterion_5

Item

Patients in whom walking impairment due to pain in the index leg is the result of these nonatherosclerotic comorbid conditions: venous claudication, chronic compartment syndrome, peripheral nerve pain (e.g., severe peripheral neuropathy), pseudoclaudication caused by spinal cord compression, or acute limb ischemia which, in the Principal Investigator's judgment are severe enough to confound the assessment of the patient's IC.

boolean

C0311395 (UMLS CUI)
10058726 (MDR)
16973004 (SNOMED CT 2010_0731)
C0521535 (UMLS CUI)
95443002 (SNOMED CT 2010_0731)
C0436020 (UMLS CUI)
212385001 (SNOMED CT 2010_0731)
C0031117 (UMLS CUI)
G64 (ICD10CM)
350-359.99 (ICD9CM)
10029331 (MDR)
302226006 (SNOMED CT 2010_0731)
C0410647 (UMLS CUI)
10041539 (MDR)
240219003 (SNOMED CT 2010_0731)
C0340565 (UMLS CUI)
233961000 (SNOMED CT 2010_0731)
CL102947 (UMLS CUI)

ExclusionCriterion_6

Item

Conditions other than IC of significant severity that could confound PWT on the standardized exercise treadmill test causing premature or inconsistent termination of exercise (e.g., angina pectoris, heart failure [New York Heart Association {NYHA} Classes III and IV], respiratory disease [e.g., chronic obstructive pulmonary disease], orthopedic disease, neurological disorders, rheumatologic disorders [e.g., severe degenerative joint diseases], dyspnea, fatigue, prior lower limb amputation, including amputations proximal to the metatarsal or phalangeal joints).

boolean

C0021775 (UMLS CUI)
I73.9 (ICD10CM)
10022562 (MDR)
63491006 (SNOMED CT 2010_0731)
C0430506 (UMLS CUI)
302761001 (SNOMED CT 2010_0731)
C0087110 (UMLS CUI)
10044555 (MDR)
C0002962 (UMLS CUI)
E10110 (CTCAE)
I20 (ICD10CM)
413 (ICD9CM)
10002383 (MDR)
194828000 (SNOMED CT 2010_0731)
C0018801 (UMLS CUI)
E10124 (CTCAE)
I50 (ICD10CM)
428 (ICD9CM)
10007554 (MDR)
84114007 (SNOMED CT 2010_0731)
C1319795 (UMLS CUI)
10064081 (MDR)
420913000 (SNOMED CT 2010_0731)
C1319796 (UMLS CUI)
10064082 (MDR)
422293003 (SNOMED CT 2010_0731)
C0035204 (UMLS CUI)
J00-J99 (ICD10CM)
460-519.99 (ICD9CM)
10038683 (MDR)
50043002 (SNOMED CT 2010_0731)
C0263661 (UMLS CUI)
10031173 (MDR)
88230002 (SNOMED CT 2010_0731)
C0027765 (UMLS CUI)
G00-G99 (ICD10CM)
349.9 (ICD9CM)
10029202 (MDR)
118940003 (SNOMED CT 2010_0731)
C0009326 (UMLS CUI)
10009903 (MDR)
81573002 (SNOMED CT 2010_0731)
C0029408 (UMLS CUI)
M15-M19 (ICD10CM)
715.9 (ICD9CM)
10031161 (MDR)
225655006 (SNOMED CT 2010_0731)
C0013404 (UMLS CUI)
E13368 (CTCAE)
R06.0 (ICD10CM)
786.05 (ICD9CM)
10013968 (MDR)
267036007 (SNOMED CT 2010_0731)
C0015672 (UMLS CUI)
E11098 (CTCAE)
R53.83 (ICD10CM)
MTHU013358 (LNC)
10016256 (MDR)
84229001 (SNOMED CT 2010_0731)
C0337308 (UMLS CUI)
84.1 (ICD9CM)
10024124 (MDR)
397117006 (SNOMED CT 2010_0731)
C0188494 (UMLS CUI)
84.13 (ICD9CM)
397218006 (SNOMED CT 2010_0731)
C0408870 (UMLS CUI)
239591008 (SNOMED CT 2010_0731)

ExclusionCriterion_7

Item

Presence or history of cancer within 5 years of enrollment or not current with recommended screening guidelines for colorectal, lung, prostate, breast, cervical, and uterine cancers, with the exception of low grade and fully resolved non-melanoma skin malignancy.

boolean

C0006826 (UMLS CUI)
C00-C96 (ICD10CM)
199 (ICD9CM)
MTHU010328 (LNC)
10028997 (MDR)
363346000 (SNOMED CT 2010_0731)
C1516879 (UMLS CUI)
C0199230 (UMLS CUI)
15886004 (SNOMED CT 2010_0731)
C0281185 (UMLS CUI)
C0281477 (UMLS CUI)
275981009 (SNOMED CT 2010_0731)
C0281186 (UMLS CUI)
C1536442 (UMLS CUI)
C0281187 (UMLS CUI)
C0677799 (UMLS CUI)
C0037286 (UMLS CUI)
10029098 (MDR)
126488004 (SNOMED CT 2010_0731)
C1334989 (UMLS CUI)

ExclusionCriterion_8

Item

Patients with a well-defined clinical or genetic disorder predisposing to malignancy should be excluded (e.g., von Hippel Lindau, familial polyposis coli, BRCA1, BRCA2, etc).

boolean

C0032927 (UMLS CUI)
C0019562 (UMLS CUI)
Q85.8 (ICD10CM)
10047716 (MDR)
46659004 (SNOMED CT 2010_0731)
C0032580 (UMLS CUI)
10056981 (MDR)
72900001 (SNOMED CT 2010_0731)
C0376571 (UMLS CUI)
C0598034 (UMLS CUI)

ExclusionCriterion_8

Item

Patients with a well-defined clinical or genetic disorder predisposing to malignancy should be excluded (e.g., von Hippel Lindau, familial polyposis coli, BRCA1, BRCA2, etc).

boolean

ExclusionCriterion_9

Item

Patients with baseline funduscopic evidence of active proliferative diabetic retinopathy, preproliferative diabetic retinopathy, or wet AMD AND/OR Patients with a history of treatment for active proliferative diabetic retinopathy or wet AMD within 5 years of enrollment.

boolean

C0029090 (UMLS CUI)
16.21 (ICD9CM)
10017519 (MDR)
53524009 (SNOMED CT 2010_0731)
C0011884 (UMLS CUI)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
C0271084 (UMLS CUI)
H35.32 (ICD10CM)
362.52 (ICD9CM)
10015902 (MDR)
414173003 (SNOMED CT 2010_0731)
C1516879 (UMLS CUI)

ExclusionCriterion_10

Item

Diabetes type 1 (juvenile onset)

boolean

C0011854 (UMLS CUI)
E10 (ICD10CM)
MTHU020217 (LNC)
10067584 (MDR)
46635009 (SNOMED CT 2010_0731)

ExclusionCriterion_11

Item

Poorly controlled type 2 diabetes (ie, HbA1C >10%) at Screening

boolean

C0011860 (UMLS CUI)
E11 (ICD10CM)
10067585 (MDR)
44054006 (SNOMED CT 2010_0731)
C0366781 (UMLS CUI)
4548-4 (LNC)

ExclusionCriterion_12

Item

Active hepatitis defined as clinically significant increase in liver enzymes (ie, 3 times the ULN) or other current infectious disease

boolean

C0019158 (UMLS CUI)
K75.9 (ICD10CM)
573.3 (ICD9CM)
10019717 (MDR)
128241005 (SNOMED CT 2010_0731)
C1860080 (UMLS CUI)
C1290884 (UMLS CUI)
128139000 (SNOMED CT 2010_0731)

ExclusionCriterion_13

Item

Patients with symptoms of respiratory infection at time of Screening and/or randomization period and/or patients who have been on systemic or oral antibiotics for active infection within 2 weeks of study drug administration.

boolean

C0035243 (UMLS CUI)
MTHU026191 (LNC)
10024970 (MDR)
275498002 (SNOMED CT 2010_0731)
C0338237 (UMLS CUI)
10067768 (MDR)
281789004 (SNOMED CT 2010_0731)
C1290884 (UMLS CUI)
128139000 (SNOMED CT 2010_0731)

ExclusionCriterion_14

Item

Patients with clinically significant abnormal hematology (eg, hematocrit < 30%, white blood cell count > 14,000), blood chemistry, renal, hepatic, or other laboratory parameters that could be the result of an underlying malignancy or systemic infection (e.g., serum creatinine ≥ 2.5 mg/dL), as judged by the investigator.

boolean

C1112712 (UMLS CUI)
10057755 (MDR)
C0366777 (UMLS CUI)
4544-3 (LNC)
C0484430 (UMLS CUI)
6690-2 (LNC)
C1332129 (UMLS CUI)
C0438215 (UMLS CUI)
10023547 (MDR)
309158009 (SNOMED CT 2010_0731)
C0006826 (UMLS CUI)
C00-C96 (ICD10CM)
199 (ICD9CM)
MTHU010328 (LNC)
10028997 (MDR)
363346000 (SNOMED CT 2010_0731)
C0243026 (UMLS CUI)
995.91 (ICD9CM)
10040047 (MDR)
91302008 (SNOMED CT 2010_0731)
C0151578 (UMLS CUI)
E12137 (CTCAE)
10011368 (MDR)
CL102947 (UMLS CUI)

ExclusionCriterion_15

Item

Patients with the following comorbidities who may not be healthy enough to successfully complete all protocol requirements or in whom results may be particularly difficult to assess: Concurrent severe congestive heart failure (NYHA Classes III and IV); Life-threatening ventricular arrhythmias, unstable angina (characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged duration), and/or myocardial infarction within 4 weeks before enrollment; Coronary artery bypass grafting or percutaneous coronary intervention within 3 months before enrollment; A renal and/or carotid revascularization procedure within 1 month of enrollment; Transient ischemic attack within 3 months before enrollment; Deep vein thrombosis within 3 months before enrollment; Severe chronic obstructive pulmonary disease (room air arterial PO2 < 60 mmHg or PCO2 > 50 mmHg, or abnormal pulmonary function tests (FEV1 < 1.2 L/sec); Thrombocytopenia (defined as platelet count < 100,000/mm3); Undergoing hemodialysis; Patients with immunocompromised conditions, organ transplant recipients and/or need for immunosuppressive therapy; Neurological dementia (i.e., Alzheimer's Disease); Hemorrhagic stroke

boolean

C0018801 (UMLS CUI)
E10124 (CTCAE)
I50 (ICD10CM)
428 (ICD9CM)
10007554 (MDR)
84114007 (SNOMED CT 2010_0731)
C1319795 (UMLS CUI)
10064081 (MDR)
420913000 (SNOMED CT 2010_0731)
C1319796 (UMLS CUI)
10064082 (MDR)
422293003 (SNOMED CT 2010_0731)
C0085612 (UMLS CUI)
10047281 (MDR)
44103008 (SNOMED CT 2010_0731)
C0002965 (UMLS CUI)
I20.0 (ICD10CM)
411.1 (ICD9CM)
10002388 (MDR)
4557003 (SNOMED CT 2010_0731)
C0027051 (UMLS CUI)
E10152 (CTCAE)
I21-I22 (ICD10CM)
10028596 (MDR)
22298006 (SNOMED CT 2010_0731)
C0010055 (UMLS CUI)
36.10 (ICD9CM)
10011077 (MDR)
232717009 (SNOMED CT 2010_0731)
C1532338 (UMLS CUI)
10065608 (MDR)
415070008 (SNOMED CT 2010_0731)
C0581603 (UMLS CUI)
297183000 (SNOMED CT 2010_0731)
C0035065 (UMLS CUI)
MTHU016747 (LNC)
2841007 (SNOMED CT 2010_0731)
C0007272 (UMLS CUI)
MTHU011911 (LNC)
69105007 (SNOMED CT 2010_0731)
C0007787 (UMLS CUI)
E12834 (CTCAE)
G45.9 (ICD10CM)
MTHU020810 (LNC)
10044390 (MDR)
266257000 (SNOMED CT 2010_0731)
C0149871 (UMLS CUI)
I82.40 (ICD10CM)
MTHU020788 (LNC)
10051055 (MDR)
128053003 (SNOMED CT 2010_0731)
C0024117 (UMLS CUI)
J44.9 (ICD10CM)
10009033 (MDR)
13645005 (SNOMED CT 2010_0731)
C0202155 (UMLS CUI)
10035766 (MDR)
25579001 (SNOMED CT 2010_0731)
C0201931 (UMLS CUI)
10034180 (MDR)
25284008 (SNOMED CT 2010_0731)
C0476405 (UMLS CUI)
R94.2 (ICD10CM)
794.2 (ICD9CM)
10061602 (MDR)
165019004 (SNOMED CT 2010_0731)
CL414841 (UMLS CUI)
C0040034 (UMLS CUI)
E12207 (CTCAE)
D69.6 (ICD10CM)
287.5 (ICD9CM)
10043554 (MDR)
415116008 (SNOMED CT 2010_0731)
C0362994 (UMLS CUI)
777-3 (LNC)
C0019004 (UMLS CUI)
39.95 (ICD9CM)
10018875 (MDR)
302497006 (SNOMED CT 2010_0731)
C0085393 (UMLS CUI)
370388006 (SNOMED CT 2010_0731)
C0376387 (UMLS CUI)
C0021079 (UMLS CUI)
86553008 (SNOMED CT 2010_0731)
C0497327 (UMLS CUI)
F03 (ICD10CM)
290 (ICD9CM)
10012267 (MDR)
52448006 (SNOMED CT 2010_0731)
C0002395 (UMLS CUI)
G30 (ICD10CM)
331.0 (ICD9CM)
10001896 (MDR)
26929004 (SNOMED CT 2010_0731)
C0553692 (UMLS CUI)
10019016 (MDR)
230706003 (SNOMED CT 2010_0731)
C1516879 (UMLS CUI)

ExclusionCriterion_16

Item

Patients with a known allergy to the vehicle, placebo control, or any other medications or imaging agents required for participation in this study.

boolean

C0013182 (UMLS CUI)
DALG (HL7V3.0)
T88.7 (ICD10CM)
10013700 (MDR)
416098002 (SNOMED CT 2010_0731)
C0570562 (UMLS CUI)
10066973 (MDR)
293637006 (SNOMED CT 2010_0731)

ExclusionCriterion_17

Item

Fertile women who are pregnant (as confirmed by a serum pregnancy test at the Screening Visit and a urine pregnancy test at Day 0 prior to study drug administration), nursing, or using either no or an inadequate form of contraception.

boolean

C0427780 (UMLS CUI)
10036574 (MDR)
250425007 (SNOMED CT 2010_0731)
C0006147 (UMLS CUI)
10006247 (MDR)
169741004 (SNOMED CT 2010_0731)
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)

ExclusionCriterion_18

Item

Fertile men and women who are not willing to use barrier-type contraception for at least 90 days post-treatment.

boolean

C0004764 (UMLS CUI)
225370004 (SNOMED CT 2010_0731)

ExclusionCriterion_19

Item

Patients with a recent history of alcoholism or drug abuse, or severe emotional, behavioral or psychiatric problems, who may not be able to adequately comply with the requirements of the study.

boolean

C0001973 (UMLS CUI)
F10.2 (ICD10CM)
303 (ICD9CM)
10001639 (MDR)
7200002 (SNOMED CT 2010_0731)
C0004936 (UMLS CUI)
F01-F99 (ICD10CM)
290-319.99 (ICD9CM)
10061284 (MDR)
74732009 (SNOMED CT 2010_0731)
C0013146 (UMLS CUI)
305 (ICD9CM)
MTHU019367 (LNC)
10013654 (MDR)
26416006 (SNOMED CT 2010_0731)

ExclusionCriterion_20

Item

Patients receiving experimental medications or participating in another study using an experimental drug or experimental procedure within 30 days of enrollment into this study.

boolean

C0304229 (UMLS CUI)
902003 (SNOMED CT 2010_0731)
C1516879 (UMLS CUI)

ExclusionCriterion_21

Item

Patients previously enrolled in a prior angiogenic gene therapy clinical study, unless patient was a known placebo patient.

boolean

C1514459 (UMLS CUI)
C0032042 (UMLS CUI)

Medical Concepts

Item Group

Medical Concepts

Healthy Subject

Item

Healthy Subject

string

C1708335 (UMLS CUI)

Gender

Item

Gender

string

C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LNC)

Age

Item

Age

string

C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)

Peripheral Arterial Diseases

Item

Peripheral Arterial Diseases

string

C1704436 (UMLS CUI)
067825 (MDR)
399957001 (SNOMED CT 2010_0731)

Atherosclerosis

Item

Atherosclerosis

string

C0004153 (UMLS CUI)
I70 (ICD10CM)
440 (ICD9CM)
10003601 (MDR)
38716007 (SNOMED CT 2010_0731)

Lower Extremity

Item

Lower Extremity

string

C0023216 (UMLS CUI)
MTHU011970 (LNC)
61685007 (SNOMED CT 2010_0731)

Ankle-Brachial Index

Item

Ankle-Brachial Index

string

C1328319 (UMLS CUI)
10062762 (MDR)

Treadmill Tests

Item

Treadmill Tests

string

C0087110 (UMLS CUI)
10044555 (MDR)

Femoropopliteal stenosis

Item

Femoropopliteal stenosis

string

C2721556 (UMLS CUI)
10069344 (MDR)

Crural artery

Item

Crural artery

string

C0447110 (UMLS CUI)
244336000 (SNOMED CT 2010_0731)

Stenosis

Item

Stenosis

string

C1261287 (UMLS CUI)

Image Study

Item

Image Study

string

C1881134 (UMLS CUI)
MTHU029412 (LNC)

Toe-Brachial Index

Item

Toe-Brachial Index

string

C2116889 (UMLS CUI)

Intermittent Claudication

Item

Intermittent Claudication

string

C0021775 (UMLS CUI)
I73.9 (ICD10CM)
10022562 (MDR)
63491006 (SNOMED CT 2010_0731)

Walking exercise test

Item

Walking exercise test

string

C0430506 (UMLS CUI)
302761001 (SNOMED CT 2010_0731)

Investigator

Item

Investigator

string

CL102947 (UMLS CUI)

Patient notified

Item

Patient notified

string

C1631603 (UMLS CUI)
419733004 (SNOMED CT 2010_0731)

treatment options

Item

treatment options

string

C0683525 (UMLS CUI)

Enrollment

Item

Enrollment

string

C1516879 (UMLS CUI)

Severity

Item

Severity

string

C0439793 (UMLS CUI)
246112005 (SNOMED CT 2010_0731)

Concomitant Medication Ongoing

Item

Concomitant Medication Ongoing

string

C2826666 (UMLS CUI)

Coronary heart disease

Item

Coronary heart disease

string

C0010068 (UMLS CUI)
I25.1 (ICD10CM)
10068617 (MDR)
53741008 (SNOMED CT 2010_0731)

Smoking Status

Item

Smoking Status

string

C1519386 (UMLS CUI)

Exercise

Item

Exercise

string

C0015259 (UMLS CUI)
10015634 (MDR)
183301007 (SNOMED CT 2010_0731)

Stable status

Item

Stable status

string

C0205360 (UMLS CUI)
MTHU015276 (LNC)
58158008 (SNOMED CT 2010_0731)

Informed Consent

Item

Informed Consent

string

C0021430 (UMLS CUI)

Critical limb ischaemia

Item

Critical limb ischaemia

string

C1142264 (UMLS CUI)
10058072 (MDR)

Lower limb ischemia

Item

Lower limb ischemia

string

C0340565 (UMLS CUI)
233961000 (SNOMED CT 2010_0731)

Immune System Disorder

Item

Immune System Disorder

string

C0021053 (UMLS CUI)
D89.9 (ICD10CM)
279 (ICD9CM)
10021425 (MDR)
41266007 (SNOMED CT 2010_0731)

Inflammatory Disorder

Item

Inflammatory Disorder

string

C1290884 (UMLS CUI)
128139000 (SNOMED CT 2010_0731)

Thromboangiitis Obliterans

Item

Thromboangiitis Obliterans

string

C0040021 (UMLS CUI)
I73.1 (ICD10CM)
443.1 (ICD9CM)
10043540 (MDR)
52403007 (SNOMED CT 2010_0731)

Systemic Scleroderma

Item

Systemic Scleroderma

string

C0036421 (UMLS CUI)
M34.0 (ICD10CM)
710.1 (ICD9CM)
10042953 (MDR)
89155008 (SNOMED CT 2010_0731)

Revascularization of lower limb

Item

Revascularization of lower limb

string

C0472670 (UMLS CUI)
233505002 (SNOMED CT 2010_0731)

Aortoiliac atherosclerosis

Item

Aortoiliac atherosclerosis

string

C0729733 (UMLS CUI)
233956002 (SNOMED CT 2010_0731)

Bypass

Item

Bypass

string

C0741847 (UMLS CUI)
88834003 (SNOMED CT 2010_0731)

Lameness

Item

Lameness

string

C0311395 (UMLS CUI)
10058726 (MDR)
16973004 (SNOMED CT 2010_0731)

Venous intermittent claudication

Item

Venous intermittent claudication

string

C0521535 (UMLS CUI)
95443002 (SNOMED CT 2010_0731)

Compartment syndrome of lower limb

Item

Compartment syndrome of lower limb

string

C0436020 (UMLS CUI)
212385001 (SNOMED CT 2010_0731)

Peripheral Neuropathy

Item

Peripheral Neuropathy

string

C0031117 (UMLS CUI)
G64 (ICD10CM)
350-359.99 (ICD9CM)
10029331 (MDR)
302226006 (SNOMED CT 2010_0731)

Spinal claudication

Item

Spinal claudication

string

C0410647 (UMLS CUI)
10041539 (MDR)
240219003 (SNOMED CT 2010_0731)

Angina Pectoris

Item

Angina Pectoris

string

C0002962 (UMLS CUI)
E10110 (CTCAE)
I20 (ICD10CM)
413 (ICD9CM)
10002383 (MDR)
194828000 (SNOMED CT 2010_0731)

Heart failure

Item

Heart failure

string

C0018801 (UMLS CUI)
E10124 (CTCAE)
I50 (ICD10CM)
428 (ICD9CM)
10007554 (MDR)
84114007 (SNOMED CT 2010_0731)

New York Heart Association Class III

Item

New York Heart Association Class III

string

C1319795 (UMLS CUI)
10064081 (MDR)
420913000 (SNOMED CT 2010_0731)

New York Heart Association Class IV

Item

New York Heart Association Class IV

string

C1319796 (UMLS CUI)
10064082 (MDR)
422293003 (SNOMED CT 2010_0731)

Respiration Disorders

Item

Respiration Disorders

string

C0035204 (UMLS CUI)
J00-J99 (ICD10CM)
460-519.99 (ICD9CM)
10038683 (MDR)
50043002 (SNOMED CT 2010_0731)

Disorder of skeletal system

Item

Disorder of skeletal system

string

C0263661 (UMLS CUI)
10031173 (MDR)
88230002 (SNOMED CT 2010_0731)

nervous system disorder

Item

nervous system disorder

string

C0027765 (UMLS CUI)
G00-G99 (ICD10CM)
349.9 (ICD9CM)
10029202 (MDR)
118940003 (SNOMED CT 2010_0731)

Collagen Diseases

Item

Collagen Diseases

string

C0009326 (UMLS CUI)
10009903 (MDR)
81573002 (SNOMED CT 2010_0731)

Degenerative polyarthritis

Item

Degenerative polyarthritis

string

C0029408 (UMLS CUI)
M15-M19 (ICD10CM)
715.9 (ICD9CM)
10031161 (MDR)
225655006 (SNOMED CT 2010_0731)

Dyspnea

Item

Dyspnea

string

C0013404 (UMLS CUI)
E13368 (CTCAE)
R06.0 (ICD10CM)
786.05 (ICD9CM)
10013968 (MDR)
267036007 (SNOMED CT 2010_0731)

Fatigue

Item

Fatigue

string

C0015672 (UMLS CUI)
E11098 (CTCAE)
R53.83 (ICD10CM)
MTHU013358 (LNC)
10016256 (MDR)
84229001 (SNOMED CT 2010_0731)

Amputation of lower limb

Item

Amputation of lower limb

string

C0337308 (UMLS CUI)
84.1 (ICD9CM)
10024124 (MDR)
397117006 (SNOMED CT 2010_0731)

Amputation of ankle (procedure)

Item

Amputation of ankle (procedure)

string

C0188494 (UMLS CUI)
84.13 (ICD9CM)
397218006 (SNOMED CT 2010_0731)

Midfoot amputation

Item

Midfoot amputation

string

C0408870 (UMLS CUI)
239591008 (SNOMED CT 2010_0731)

Malignant Neoplasms

Item

Malignant Neoplasms

string

C0006826 (UMLS CUI)
C00-C96 (ICD10CM)
199 (ICD9CM)
MTHU010328 (LNC)
10028997 (MDR)
363346000 (SNOMED CT 2010_0731)

Screening for cancer

Item

Screening for cancer

string

C0199230 (UMLS CUI)
15886004 (SNOMED CT 2010_0731)

Screening for Colorectal Cancer

Item

Screening for Colorectal Cancer

string

C0281185 (UMLS CUI)

Screening for Lung Cancer

Item

Screening for Lung Cancer

string

C0281477 (UMLS CUI)
275981009 (SNOMED CT 2010_0731)

Screening for Prostate Cancer

Item

Screening for Prostate Cancer

string

C0281186 (UMLS CUI)

Breast Cancer Screening

Item

Breast Cancer Screening

string

C1536442 (UMLS CUI)

Cervical Cancer Screening

Item

Cervical Cancer Screening

string

C0281187 (UMLS CUI)

Screening for Endometrial Cancer

Item

Screening for Endometrial Cancer

string

C0677799 (UMLS CUI)

Skin Neoplasms

Item

Skin Neoplasms

string

C0037286 (UMLS CUI)
10029098 (MDR)
126488004 (SNOMED CT 2010_0731)

Non-Melanomatous Lesion

Item

Non-Melanomatous Lesion

string

C1334989 (UMLS CUI)

Precancerous Conditions

Item

Precancerous Conditions

string

C0032927 (UMLS CUI)

Von Hippel-Lindau Syndrome

Item

Von Hippel-Lindau Syndrome

string

C0019562 (UMLS CUI)
Q85.8 (ICD10CM)
10047716 (MDR)
46659004 (SNOMED CT 2010_0731)

Adenomatous Polyposis Coli

Item

Adenomatous Polyposis Coli

string

C0032580 (UMLS CUI)
10056981 (MDR)
72900001 (SNOMED CT 2010_0731)

BRCA1 gene

Item

BRCA1 gene

string

C0376571 (UMLS CUI)

BRCA2 gene

Item

BRCA2 gene

string

C0598034 (UMLS CUI)

Ophthalmoscopy

Item

Ophthalmoscopy

string

C0029090 (UMLS CUI)
16.21 (ICD9CM)
10017519 (MDR)
53524009 (SNOMED CT 2010_0731)

Diabetic Retinopathy

Item

Diabetic Retinopathy

string

C0011884 (UMLS CUI)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)

Exudative age-related macular degeneration

Item

Exudative age-related macular degeneration

string

C0271084 (UMLS CUI)
H35.32 (ICD10CM)
362.52 (ICD9CM)
10015902 (MDR)
414173003 (SNOMED CT 2010_0731)

Diabetes Mellitus, Insulin-Dependent

Item

Diabetes Mellitus, Insulin-Dependent

string

C0011854 (UMLS CUI)
E10 (ICD10CM)
MTHU020217 (LNC)
10067584 (MDR)
46635009 (SNOMED CT 2010_0731)

Diabetes Mellitus, Non-Insulin-Dependent

Item

Diabetes Mellitus, Non-Insulin-Dependent

string

C0011860 (UMLS CUI)
E11 (ICD10CM)
10067585 (MDR)
44054006 (SNOMED CT 2010_0731)

Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn

Item

Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn

string

C0366781 (UMLS CUI)
4548-4 (LNC)

Hepatitis

Item

Hepatitis

string

C0019158 (UMLS CUI)
K75.9 (ICD10CM)
573.3 (ICD9CM)
10019717 (MDR)
128241005 (SNOMED CT 2010_0731)

Increased liver enzymes

Item

Increased liver enzymes

string

C1860080 (UMLS CUI)

Respiratory Tract Infections

Item

Respiratory Tract Infections

string

C0035243 (UMLS CUI)
MTHU026191 (LNC)
10024970 (MDR)
275498002 (SNOMED CT 2010_0731)

Antibiotic Therapy

Item

Antibiotic Therapy

string

C0338237 (UMLS CUI)
10067768 (MDR)
281789004 (SNOMED CT 2010_0731)

Abnormal Hematology Test Result

Item

Abnormal Hematology Test Result

string

C1112712 (UMLS CUI)
10057755 (MDR)

Hematocrit:VFr:Pt:Bld:Qn:Automated count

Item

Hematocrit:VFr:Pt:Bld:Qn:Automated count

string

C0366777 (UMLS CUI)
4544-3 (LNC)

Leukocytes:NCnc:Pt:Bld:Qn:Automated count

Item

Leukocytes:NCnc:Pt:Bld:Qn:Automated count

string

C0484430 (UMLS CUI)
6690-2 (LNC)

Abnormal Blood Chemistry and Hematology Test Result

Item

Abnormal Blood Chemistry and Hematology Test Result

string

C1332129 (UMLS CUI)

Abnormal Laboratory Test Result

Item

Abnormal Laboratory Test Result

string

C0438215 (UMLS CUI)
10023547 (MDR)
309158009 (SNOMED CT 2010_0731)

Increased Creatinine

Item

Increased Creatinine

string

C0151578 (UMLS CUI)
E12137 (CTCAE)
10011368 (MDR)

Ventricular arrhythmia

Item

Ventricular arrhythmia

string

C0085612 (UMLS CUI)
10047281 (MDR)
44103008 (SNOMED CT 2010_0731)

Angina, Unstable

Item

Angina, Unstable

string

C0002965 (UMLS CUI)
I20.0 (ICD10CM)
411.1 (ICD9CM)
10002388 (MDR)
4557003 (SNOMED CT 2010_0731)

Myocardial Infarction

Item

Myocardial Infarction

string

C0027051 (UMLS CUI)
E10152 (CTCAE)
I21-I22 (ICD10CM)
10028596 (MDR)
22298006 (SNOMED CT 2010_0731)

Coronary Artery Bypass Surgery

Item

Coronary Artery Bypass Surgery

string

C0010055 (UMLS CUI)
36.10 (ICD9CM)
10011077 (MDR)
232717009 (SNOMED CT 2010_0731)

Percutaneous coronary intervention

Item

Percutaneous coronary intervention

string

C1532338 (UMLS CUI)
10065608 (MDR)
415070008 (SNOMED CT 2010_0731)

Revascularization - action

Item

Revascularization - action

string

C0581603 (UMLS CUI)
297183000 (SNOMED CT 2010_0731)

Structure of renal artery

Item

Structure of renal artery

string

C0035065 (UMLS CUI)
MTHU016747 (LNC)
2841007 (SNOMED CT 2010_0731)

Carotid Arteries

Item

Carotid Arteries

string

C0007272 (UMLS CUI)
MTHU011911 (LNC)
69105007 (SNOMED CT 2010_0731)

Transient Ischemic Attack

Item

Transient Ischemic Attack

string

C0007787 (UMLS CUI)
E12834 (CTCAE)
G45.9 (ICD10CM)
MTHU020810 (LNC)
10044390 (MDR)
266257000 (SNOMED CT 2010_0731)

Deep Vein Thrombosis

Item

Deep Vein Thrombosis

string

C0149871 (UMLS CUI)
I82.40 (ICD10CM)
MTHU020788 (LNC)
10051055 (MDR)
128053003 (SNOMED CT 2010_0731)

Chronic Obstructive Airway Disease

Item

Chronic Obstructive Airway Disease

string

C0024117 (UMLS CUI)
J44.9 (ICD10CM)
10009033 (MDR)
13645005 (SNOMED CT 2010_0731)

Partial Pressure of Oxygen Measurement

Item

Partial Pressure of Oxygen Measurement

string

C0202155 (UMLS CUI)
10035766 (MDR)
25579001 (SNOMED CT 2010_0731)

Partial Pressure of Carbon Dioxide Measurement

Item

Partial Pressure of Carbon Dioxide Measurement

string

C0201931 (UMLS CUI)
10034180 (MDR)
25284008 (SNOMED CT 2010_0731)

Lung function testing abnormal

Item

Lung function testing abnormal

string

C0476405 (UMLS CUI)
R94.2 (ICD10CM)
794.2 (ICD9CM)
10061602 (MDR)
165019004 (SNOMED CT 2010_0731)

Forced Expiratory Volume in 1 Second

Item

Forced Expiratory Volume in 1 Second

string

CL414841 (UMLS CUI)

Thrombocytopenia

Item

Thrombocytopenia

string

C0040034 (UMLS CUI)
E12207 (CTCAE)
D69.6 (ICD10CM)
287.5 (ICD9CM)
10043554 (MDR)
415116008 (SNOMED CT 2010_0731)

Platelet # Bld Auto

Item

Platelet # Bld Auto

string

C0362994 (UMLS CUI)
777-3 (LNC)

Hemodialysis

Item

Hemodialysis

string

C0019004 (UMLS CUI)
39.95 (ICD9CM)
10018875 (MDR)
302497006 (SNOMED CT 2010_0731)

Immunocompromised

Item

Immunocompromised

string

C0085393 (UMLS CUI)
370388006 (SNOMED CT 2010_0731)

Transplant Recipients

Item

Transplant Recipients

string

C0376387 (UMLS CUI)

Therapeutic immunosuppression

Item

Therapeutic immunosuppression

string

C0021079 (UMLS CUI)
86553008 (SNOMED CT 2010_0731)

Dementia

Item

Dementia

string

C0497327 (UMLS CUI)
F03 (ICD10CM)
290 (ICD9CM)
10012267 (MDR)
52448006 (SNOMED CT 2010_0731)

Alzheimer's Disease

Item

Alzheimer's Disease

string

C0002395 (UMLS CUI)
G30 (ICD10CM)
331.0 (ICD9CM)
10001896 (MDR)
26929004 (SNOMED CT 2010_0731)

Brain hemorrhage

Item

Brain hemorrhage

string

C0553692 (UMLS CUI)
10019016 (MDR)
230706003 (SNOMED CT 2010_0731)

Drug Allergy

Item

Drug Allergy

string

C0013182 (UMLS CUI)
DALG (HL7V3.0)
T88.7 (ICD10CM)
10013700 (MDR)
416098002 (SNOMED CT 2010_0731)

Contrast media allergy

Item

Contrast media allergy

string

C0570562 (UMLS CUI)
10066973 (MDR)
293637006 (SNOMED CT 2010_0731)

Negative Pregnancy Test

Item

Negative Pregnancy Test

string

C0427780 (UMLS CUI)
10036574 (MDR)
250425007 (SNOMED CT 2010_0731)

Breastfeeding

Item

Breastfeeding

string

C0006147 (UMLS CUI)
10006247 (MDR)
169741004 (SNOMED CT 2010_0731)

Contraceptive methods

Item

Contraceptive methods

string

C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)

Contraception, Barrier

Item

Contraception, Barrier

string

C0004764 (UMLS CUI)
225370004 (SNOMED CT 2010_0731)

Alcoholic Intoxication, Chronic

Item

Alcoholic Intoxication, Chronic

string

C0001973 (UMLS CUI)
F10.2 (ICD10CM)
303 (ICD9CM)
10001639 (MDR)
7200002 (SNOMED CT 2010_0731)

Mental disorders

Item

Mental disorders

string

C0004936 (UMLS CUI)
F01-F99 (ICD10CM)
290-319.99 (ICD9CM)
10061284 (MDR)
74732009 (SNOMED CT 2010_0731)

Drug abuse

Item

Drug abuse

string

C0013146 (UMLS CUI)
305 (ICD9CM)
MTHU019367 (LNC)
10013654 (MDR)
26416006 (SNOMED CT 2010_0731)

Experimental drug

Item

Experimental drug

string

C0304229 (UMLS CUI)
902003 (SNOMED CT 2010_0731)

Prior Gene Therapy

Item

Prior Gene Therapy

string

C1514459 (UMLS CUI)

Placebos

Item

Placebos

string

C0032042 (UMLS CUI)

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Eligibility NCT00117650 # Intermittent Claudication

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