Diabetes, Vascular Diseases
Conditions
Keywords
Critical limb ischemia, Diabetes, Femoropopliteal artery bypass, Stent
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 and part II focuses on the treatment of below-knee 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 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.
Interventions
DEVICEfemoral-popliteal bypass
Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.
DEVICEstent
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.
Sponsors
Beijing Tongren Hospital
Xuanwu Hospital, Beijing
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occlusion of the stent or bypass | 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days | The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure. |
| Rate of limb salvage | 36 months | — |
| Procedural complications, defined as any adverse event | 36 months | including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula |
| Quality of Life assessment | 36 months | assessment in 1 month,6 months,12 months,24 months and 36 months post procedure |
| Restenosis measured by Duplex Ultrasound or CTA | 36 months | — |
Countries
China
Outcome results
None listed