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

Atherosclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514460
• Other study ID #: Z141107002514063
• Status: Completed
• Phase: N/A
• First received: July 31, 2015
• Last updated: July 11, 2016
• Start date: January 2014
• Est. completion date: April 2016

Study information

• Verified date: December 2015
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Ischemia

Intervention

Device:
• plaque excision system

• Stent

Locations

Country	Name	City	State
China	Gu Yong Quan	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	12-month Limb Salvage Rate	Limb Salvage is defined as the freedom from secondary major amputation	12 months	Yes
Secondary	Index Limb Ischemia at 6-month Follow up	Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.	6 months	Yes
Secondary	Index Limb Ischemia at 12-month Follow up	Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.	12 months	Yes
Secondary	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	Yes