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

NCT02514460 | Completed DMC

• 1 other identifier: Z141107002514063
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atherosclerosis; Ischemia

Keywords

stents; atherectomy; femoral artery; popliteal artery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Index Limb Ischemia at 6-month Follow up

  6 months

• Index Limb Ischemia at 12-month Follow up

  12 months

• Major Adverse Events at 12-month Post Procedure

  12 months

Study Arms (2)

Intervention: Stents

ACTIVE COMPARATOR

Stents group

Device: Stent

Intervention: Atherectomy

ACTIVE COMPARATOR

Direct Atherectomy group

Device: plaque excision system

Interventions

plaque excision system DEVICE

Intervention: Atherectomy

Stent DEVICE

Intervention: Stents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Gu Yong Quan

Beijing, Beijing Municipality, 100053, China

Location

Related 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.

  PMID: 23822938 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis; Ischemia

Interventions

Stents

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 3, 2015
• Study Start: January 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 13, 2016

Record last verified: 2015-12

Locations

CN (1)