Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part I)

Study Overview
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Brief Summary
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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 and part II focuses on the treatment of below-knee arterial lesion.

Detailed Description
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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 of the superficial femoral artery in DM patients. Totally 70 patients will be entered into the study. The lesion of the femoral artery should be TASC B、C or D and the patients should suffered ischemic symptom with Rutherford 3-6.The lesion does not extend beyond the aortoiliac artery or blow-knee popliteal artery, with at least 1 vessel infra-popliteal runoff to the foot.

Official Title
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Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part I)

Conditions
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Vascular Diseases, Diabetes

Intervention / Treatment
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* Device: femoral-popliteal bypass
* Device: stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bypass<br>femoral-popliteal bypass | Device: femoral-popliteal bypass<br>* Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.<br>|
| Experimental: stent<br> | Device: stent<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion of the stent or bypass |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure. | 30 days | 
| Rate of limb salvage |  | 36 months | 
| Procedural complications, defined as any adverse event | including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula | 36 months | 
| Quality of Life assessment | assessment in 1 month,6 months,12 months,24 months and 36 months post procedure | 36 months | 
| Restenosis measured by Duplex Ultrasound or CTA |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical limb ischemia, Diabetes, Femoropopliteal artery bypass, Stent