An interventional study of plaque excision system and Stent in Atherosclerosis and Ischemia, sponsored by Xuanwu Hospital, Beijing. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-13.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment
This is a randomized study comparing stent and plaque excision systems in treatment of lower limb (superficial femoral or popliteal artery) ischemia.
This is a randomized study comparing stent and plaque excision systems in treatment of diabetic lower limb (superficial femoral or popliteal artery) ischemia.
1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.
This study's enrollment of 120 is above the median of 106 across 882 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Provides written informed consent Willing to comply with follow-up evaluations at specified times Has claudication or rest pain due to peripheral arterial disease Disease located within the femoropopliteal artery 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 or greater.
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 bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed.
Tissue loss due to ischemic 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 Patient 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.
Patient is known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser.
Patient 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.
Stents group
Device: Stent
Direct Atherectomy group
Device: plaque excision system
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 target vessel revascularization 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.
Time frame: 12 months
12-month Limb Salvage Rate
Limb Salvage is defined as the freedom from secondary major amputation
Time frame: 12 months
Index Limb Ischemia at 6-month Follow up
Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.
Time frame: 6 months
Index Limb Ischemia at 12-month Follow up
Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.
Time frame: 12 months
Major Adverse Events at 12-month Post Procedure
Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization , and significant embolic events, which were defined as causing end-organ damage.
Time frame: 12 months
Plan to share: Undecided
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Xuanwu Hospital, Beijing