Status:
UNKNOWN
Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part I)
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Beijing Tongren Hospital
Xuanwu Hospital, Beijing
Conditions:
Vascular Diseases
Diabetes
Eligibility:
All Genders
55-75 years
Phase:
PHASE4
Brief Summary
The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of femoral arterial lesion...
Detailed Description
The trial includes two parts and here is part I. This part is a multi-center, prospective, randomized, controlled study to compare the therapeutic effect of stent and bypass to chronic long occlusion ...
Eligibility Criteria
Inclusion
- The patients volunteer to join the trial and sign the formal consent.
- The patients are ≥55 year-old and ≤75 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 lesion of the femoral artery should be TASC B、C or D.
- 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.
- Be diagnosed with DM for at least 1 year.
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 :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01171703
Start Date
November 1 2010
End Date
July 1 2016
Last Update
December 24 2012
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