Arterial Occlusive Diseases, Vascular Diseases
Conditions
Keywords
critical limb ischemia, peripheral artery occlusive disease, femoropopliteal artery bypass, Stent
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.
Interventions
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.
DEVICEfemoral-popliteal bypass with artificial blood vessel
Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.
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
45 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occlusion of the stent or artificial blood vessel bypass | 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| Increase in Ankle Brachial Index | 36 months | — |
| Restenosis measured by Duplex Ultrasound or CTA | 36 months | — |
| Rate of amputation | 36 months | — |
Countries
China
Contacts
Primary ContactLiu Changwei, bachelor
Backup ContactYe Wei, doctor
Outcome results
None listed