NCT02514460.

Study name	Clinical study of stent versus direct atherectomy to treat lower limb ischemia
Methods	Randomised, single blind (participant), parallel controlled trial
Participants	Estimated enrolment: 120 participants Ages eligible for study: 18 years and older Sexes eligible for study: all Inclusion criteria: provides written informed consent; willing to comply with follow‐up evaluations at specified times; has claudication or rest pain due to PAD; disease located within the femoropopliteal artery; participant has a de novo or restenotic lesion(s) with > 50% stenosis documented angiographically and no prior stent in the target lesion; participant has symptoms of PAD classified as Rutherford Category 2 or more. Exclusion criteria: previously implanted stent(s) or stent graft(s) in target leg; life expectancy less than 12 months; has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure; thrombophlebitis, uremia, or deep venous thrombus, within past 30 days; receiving dialysis or immunosuppressant therapy; recent stroke within past 90 days; known allergies to the following: aspirin, clopidogrel bisulphate (Plavix) or ticlopidine (Ticlid), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed; tissue loss due to ischaemic disease (Rutherford/Becker category 5 or 6); serum creatinine level ≥ 2.5 mg/dL at time of screening visit; known or suspected active infection at the time of the procedure; bleeding diathesis; participant is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow‐up visits as specified by the protocol; participant is known to be pregnant, incarcerated, mentally incompetent, alcohol or drug abuser; participant is currently participating in any other investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or future participation in such studies prior to the completion of this study.
Interventions	Arm 1: stents Arm 2: direct atherectomy group
Outcomes	Primary outcome measures: 12‐month primary patency rate. Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven TVR performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis > 50% with a peak systolic velocity ratio > 2.4 as measured by Duplex ultrasound 12‐month limb salvage rate. Limb salvage is defined as the freedom from secondary major amputation Secondary outcome measures: Index limb ischaemia at 6‐month follow‐up. Index limb ischaemia is defined by Rutherford/Becker Classification categories 3 to 6 Index limb ischaemia at 12‐month follow‐up. Index limb ischaemia is defined as for 6 months MAE at 12 months postprocedure. MAE including death, index limb ischaemia, index limb amputation, clinically driven TLR, and significant embolic events, which were defined as causing end‐organ damage
Starting date	January 2014
Contact information	Xuanwu Hospital, Beijing
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