Clinical Study of Stent Versus Direct Atherectomy to Treat Lower Limb Ischemia

Sponsor

Xuanwu Hospital, Beijing (Other)

Overall Status

Completed

CT.gov ID

NCT02514460

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized study comparing stent and plaque excision systems in treatment of lower limb (superficial femoral or popliteal artery) ischemia.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Ischemia	Device: plaque excision system Device: Stent	N/A

Detailed Description

This is a randomized study comparing stent and plaque excision systems in treatment of diabetic lower limb (superficial femoral or popliteal artery) ischemia.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention: Stents Stents group	Device: Stent
Active Comparator: Intervention: Atherectomy Direct Atherectomy group	Device: plaque excision system

Arm

Intervention/Treatment

Active Comparator: Intervention: Stents

Stents group

Device: Stent

Active Comparator: Intervention: Atherectomy

Direct Atherectomy group

Device: plaque excision system

Outcome Measures

Primary Outcome Measures

12-month Primary Patency Rate [12 months]
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.
12-month Limb Salvage Rate [12 months]
Limb Salvage is defined as the freedom from secondary major amputation

Secondary Outcome Measures

Index Limb Ischemia at 6-month Follow up [6 months]
Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.
Index Limb Ischemia at 12-month Follow up [12 months]
Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.
Major Adverse Events at 12-month Post Procedure [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.