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

NCT ID: NCT01171703

Last Updated: 2012-12-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2016-07-31

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.

Conditions

Vascular Diseases; Diabetes

Keywords

Critical limb ischemia; Diabetes; Femoropopliteal artery bypass; Stent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bypass

femoral-popliteal bypass

Group Type: EXPERIMENTAL

femoral-popliteal bypass

Intervention Type: DEVICE

Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.

stent

Group Type: EXPERIMENTAL

stent

Intervention Type: DEVICE

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.

Interventions

femoral-popliteal bypass

Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liu Chang-wei

Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liu changwei, bachelor

Role: STUDY_CHAIR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, China

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

pumch-DCLI-I

Identifier Type: -

Identifier Source: org_study_id