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

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

Study Overview

• Status: Completed
• Conditions: Ischemia; Atherosclerosis
• Intervention / Treatment: Device: Stent; Device: plaque excision system

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Gu Yong Quan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intervention: Stents; Stents group	Device: Stent
ACTIVE_COMPARATOR: Intervention: Atherectomy; Direct Atherectomy group	Device: plaque excision system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
12-month Limb Salvage Rate	Limb Salvage is defined as the freedom from secondary major amputation	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Index Limb Ischemia at 6-month Follow up	Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.	6 months
Index Limb Ischemia at 12-month Follow up	Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.	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.	12 months

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Publications and helpful links

General Publications

• Yongquan G, Lianrui G, Lixing Q, Xuefeng L, Zhu T, Shijun C, Yingfeng W, Jianming G, Jian Z, Zhonggao W. Plaque excision in the management of lower-limb ischemia of atherosclerosis and in-stent restenosis with the SilverHawk atherectomy catheter. Int Angiol. 2013 Aug;32(4):362-7.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: July 31, 2015
• First Submitted That Met QC Criteria: July 31, 2015
• First Posted (ESTIMATE): August 3, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): July 13, 2016
• Last Update Submitted That Met QC Criteria: July 11, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: atherectomy; stents; femoral artery; popliteal artery
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Ischemia; Atherosclerosis
• Other Study ID Numbers: Z141107002514063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED