Clinical trial NCT01147419: Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery
Official title: The Study to Compare the Treatment of Stent and Prothesis Bypass in SFA Occlusions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arterial Occlusive Diseases
Vascular Diseases
Keywords: critical limb ischemia
peripheral artery occlusive disease
femoropopliteal artery bypass
Stent
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tongren Hospital
name: Xuanwu Hospital, Beijing
First posted: 2010-06-22
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different strategies exist in the treatment of chronic long occlusion of the superficial femoral artery. Traditionally, these patients should be treated with bypass. If the great saphenous vein is unavailable, doctor has to choose artificial vessel as graft. Now, the skill of endovascular treatment is developing rapidly, and lots of doctors think most of such patients could be treated with stent. The purpose of this trial is to compare stent and artificial blood vessel bypass in the treatment of long occlusion of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive treatment of stent can be considered in such patients.

Detailed description: This is a multi-center, prospective, randomized, controlled trial to compare the therapeutic effect of stent and artificial blood vessel bypass to chronic long occlusion of the superficial femoral artery. Totally 200 patients will be entered into the trial. The study population will consist of patients with long superficial femoral stenosis and occlusion lesion (≥15 cm), presenting symptomatic ischemia（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.

Trial participants will be randomized to either stent group or artificial blood vessel bypass group.

Patients will be followed up for 3 years. Study examinations will be done at screening, procedure time, 1, 6, 12, 24 and 36 months after procedure.

This study will be conducted at 3 centers in Beijing, China.

Eligibility criteria: Inclusion Criteria:

* The patients volunteer to join the trial and sign the formal consent.
* The patients are ≥45 year-old and ≤80 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 total length of the femoral and popliteal artery lesion(including ≥75% stenosis and occlusion) are at least 15cm.
* 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.
* No available saphenous vein.

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.

Primary outcomes:
measure: Occlusion of the stent or artificial blood vessel bypass
timeFrame: 36 months
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Rate of limb salvage
timeFrame: 36 months
measure: Procedural complications, defined as any adverse event
timeFrame: 36 months
measure: Quality of Life assessment
timeFrame: 36 months
measure: Rate of amputation
timeFrame: 36 months
measure: Increase in Ankle Brachial Index
timeFrame: 36 months
measure: Restenosis measured by Duplex Ultrasound or CTA
timeFrame: 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital, Beijing
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
name: Liu Changwei, bachelor
role: STUDY_CHAIR
name: Ye Wei, doctor
role: PRINCIPAL_INVESTIGATOR
References: