NCT01171703

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vascular Diseases
• Diabetes

Interventions

Type	Name	Description
DEVICE	femoral-popliteal bypass	Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.
DEVICE	stent	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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-07-01
• Completion: 2016-07-01
• First posted: 2010-07-28
• Last updated: 2012-12-24

Locations

3 sites across 1 country: China