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:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT01330628
Eligibility Criteria:
Inclusion Criteria:
* PAD with Rutherford class 1-4
* Resting ABI \<0.9 or abnormal exercise ABI \<0.9
* History of previous femoropopliteal nitinol stenting
* Angiographic significant restenosis (\>=50%)
* Target lesion length \>=4 cm; no more than 3 cm outside stent at either end
* Vessel diameter \>=5 mm and \<=7 mm
* At least one widely patent tibial or peroneal artery to the foot
Exclusion Criteria:
* Patient is pregnant or breast feeding
* Evidence of acute limb ischemia
* Life expectancy \<12 months
* CVA within 60 days of screening
* Myocardial infarction within 60 days of procedure
* Known allergy to contract media
* Known contraindication to aspirin, antiplatelet and anti-coagulation therapies
* Uncontrolled hypercoagulability
* Present or suspected systemic infection in target limb
* Serum creatinine \>= 2.5 mg/dl unless dialysis dependent
* Previous treatment to target vessel within 3 months of study procedure
* Drug eluting stents or covered stents in target lesion
* Ipsilateral and/or contralateral iliac stenosis \>= 50% DS that is not successfully treated prior to index procedure or with final residual stenosis \<= 30% documented by angiography
* Planned or predicted cardiovascular surgical or interventional procedures prior to completion of the 30-day follow-up
* Identification of any lesion below the target stent in the treated leg \>50% that will require preplanned or predicted treatment within 30 days(prior to the 6 month follow up)
* Tibial artery containing a \>50% Diameter Stenosis (DS) by visual estimate after popliteal
* Grade 4 or 5 stent fracture affecting target stent or proximal to the target stent, or where evidence of stent protrusion into the lumen is noted on angiography in 2 orthogonal views.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01330628
Study Brief:
Protocol Section:
NCT01330628