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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.
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.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital, Beijing
Beijing, Beijing Municipality, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Occlusion of the stent or bypass
Time frame: 36 months
Mortality
The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure.
Time frame: 30 days
Rate of limb salvage
Time frame: 36 months
Procedural complications, defined as any adverse event
including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula
Time frame: 36 months
Quality of Life assessment
assessment in 1 month,6 months,12 months,24 months and 36 months post procedure
Time frame: 36 months
Restenosis measured by Duplex Ultrasound or CTA
Time frame: 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.