Description:

ODM derived from http://clinicaltrials.gov/show/NCT01442636

Link:

http://clinicaltrials.gov/show/NCT01442636

Keywords:
Versions (2) ▾
  1. 2/7/12
  2. 4/13/14
Uploaded on:

April 13, 2014

DOI:
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License:
Creative Commons BY 4.0
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Eligibility NCT01442636 Peripheral Arterial Disease

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Age >18 Years
Patient presenting with rest pain or minor tissue loss (Rutherford class 4 or 5)
Patient is willing to comply with specified follow-up evaluations at the specified times
Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
Life-expectancy of at least 12 months
Eligibility for treatment with XIENCE PRIME stent (Abbott Vascular)
Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
Angiographic Inclusion Criteria
De novo lesion or restenotic lesion after PTA in the infrapopliteal arteries, suitable for endovascular therapy
Target lesion length minimally 30mm and maximally 100mm
Target vessel diameter >2.0mm and <3.5mm
Guidewire and delivery system successfully traversed lesion
Exclusion Criteria
Patient refusing treatment
Reference segment diameter not suitable for stent design
Untreated flow-limiting inflow lesions
Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
Aneurysm in the target vessel
Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
Septicemia or bacteremia
Any previously known coagulation disorder, including hypercoagulability
Contraindication to anticoagulation or antiplatelet therapy
Known allergies to stent or stent components; Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
Hypersensitivity to heparin, including patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
Currently participating in another clinical research trial
Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
Target lesion access not performed by transfemoral approach
Medical Concepts