Status:
UNKNOWN
Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Beijing Tongren Hospital
Xuanwu Hospital, Beijing
Conditions:
Arterial Occlusive Diseases
Vascular Diseases
Eligibility:
All Genders
45-80 years
Phase:
PHASE4
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 una...
Detailed Description
This is a multi-center, prospective, randomized, controlled trial to compare the therapeutic effect of stent and artificial blood vessel bypass to chronic long occlusion of the superficial femoral art...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01147419
Start Date
June 1 2010
End Date
June 1 2015
Last Update
July 7 2010
Active Locations (3)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
2
Xuanwu Hospital, Beijing
Beijing, Beijing Municipality, China, 100053
3
Beijing Tongren Hospital
Beijing, Beijing Municipality, China, 100730