Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT02033135
Eligibility Criteria:
Inclusion Criteria:
* Patient has signed and dated the informed consent.
* Patient has 1- 2 documented stenotic or occluded atherosclerotic lesions (up to 18 cm long) of the above-the-knee femoropopliteal artery, that meet all of the inclusion criteria and none of the exclusion criteria.
* Reference vessel (the above-the-knee femoropopliteal artery) diameter of 4 mm to 9 mm.
* Taget lesion(s) should be accessible for stenting, as imaged with angiography (digital subtraction, MRI or CTI), i.e. proximal cm of SFA must be open
* Patient has a de novo or restenotic lesion(s) with \>50% stenosis documented angiographically and no prior stent in the target lesion.
* Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 (moderate claudication) or 3 (severe claudication) lasting for at least 3 months. (Positive Claudication Questionnaire)
* Exercise therapy, smoking cessation advise and best medical therapy must have been implemented at least 3 months ago and without significant clinical effect.
* Patient has a resting ABI \<0.9 or an abnormal exercise ABI (decrease of more than 0.15) if resting ABI is normal. Patient with incompressible arteries (ABI \>1.2) must have a TBI \<0.8.
* Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 weeks, 6 months, 12 months, and at 24 months.
Exclusion Criteria:
* Patient is pregnant, breast-feeding or under 18 years of age.
* Patient unable to understand and sign informed consent forms
* Patient is simultaneously participating in another investigational drug or device study.
* Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
* Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
* Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol.
* Patient 2-3 patent crural vessel runoff with \<50% stenosis throughout its course.
* Activity limited by co-morbid condition other than claudication, for example: severe coronary artery disease; angina pectoris; chronic lung disease; neurological disorder such as hemiparesis; arthritis, or other musculoskeletal conditions including amputation and BMI \> 40
* Other active significant medical problems such as cancer, known chronic renal disease (serum creatinine greater than 2.0 mg/dl within 60 days or renal replacement therapy), known chronic liver disease or anaemia, active substance abuse, or known history of dementia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02033135
Study Brief:
Protocol Section:
NCT02033135