Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery

NCT01147419 | Unknown Phase 4 DMC

• 1 other identifier: pumch-vascular surgery
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

Different strategies exist in the treatment of chronic long occlusion of the superficial femoral artery. Traditionally, these patients should be treated with bypass. If the great saphenous vein is unavailable, doctor has to choose artificial vessel as graft. Now, the skill of endovascular treatment is developing rapidly, and lots of doctors think most of such patients could be treated with stent. The purpose of this trial is to compare stent and artificial blood vessel bypass in the treatment of long occlusion of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive treatment of stent can be considered in such patients.

Conditions

Arterial Occlusive Diseases; Vascular Diseases

Keywords

critical limb ischemia; peripheral artery occlusive disease; femoropopliteal artery bypass; Stent

Outcome Measures

Primary Outcomes (1)

• Occlusion of the stent or artificial blood vessel bypass

  36 months

Secondary Outcomes (7)

• Mortality

  30 days

• Rate of limb salvage

  36 months

• Procedural complications, defined as any adverse event

  36 months

• Quality of Life assessment

  36 months

• Rate of amputation

  36 months

Study Arms (2)

bypass

EXPERIMENTAL

Patients presenting with long occlusion of the superficial femoral artery enrolled in bypass arm will undergo suprageniculate femoropopliteal bypass surgery to bypass the occluded superficial femoral artery. And the graft will be artificial blood vessel.

Device: femoral-popliteal bypass with artificial blood vessel

stent

EXPERIMENTAL

Device: stent

Interventions

stent DEVICE

Before operation, take aspirin 100mg every day. During the operation, stent is delivered by a catheter and positioned through the narrowing in the artery. The stent is then expanded against the wall of the blood vessel to provide a wider channel for blood. At last, use balloon dilate the stent.

stent

femoral-popliteal bypass with artificial blood vessel DEVICE

Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.

bypass

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients volunteer to join the trial and sign the formal consent.
• The patients are ≥45 year-old and ≤80 year-old.
• The patients suffer from symptomatic leg ischemia with rutherford classification3, 4 , 5 or 6. The presentation is severe intermittent claudication, rest pain, ulcer or gangrene.
• The total length of the femoral and popliteal artery lesion(including ≥75% stenosis and occlusion) are at least 15cm.
• The femoral-popliteal artery has never received bypass or endovascular therapy before.
• No obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured.
• No obvious stenosis in below-knee popliteal artery; at least 1 vessel infra-popliteal runoff to the foot.
• No surgical contraindications;no infection in operation region.
• No available saphenous vein.

You may not qualify if:

• Refuse random treatment.
• Previous operations on the superficial femoral artery.
• Acute lower extremity arterial thrombosis.
• Serious major organ failure.
• Allergic to the contrast agent or has contrast nephropathy.
• No clinical compliance or unfit to join the trial.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Beijing Tongren Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator

Study Sites (3)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, 100053, China

RECRUITING

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Links

• the website of the vascular surgery department of PUMCH

MeSH Terms

Conditions

Arterial Occlusive Diseases; Vascular Diseases; Chronic Limb-Threatening Ischemia; Peripheral Arterial Occlusive Disease 1

Interventions

Stents

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Liu Changwei, bachelor

  STUDY CHAIR

• Ye Wei, doctor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Changwei, bachelor

CONTACT

86-010-88068230; liucw@vip.sina.com

Ye Wei, doctor

CONTACT

86-010-88068230; yewill18@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 22, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2015
• Last Updated: July 7, 2010

Record last verified: 2010-07

Locations

CN (3)