Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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)
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
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_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)
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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