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| Name | Class |
|---|---|
| Beijing Tongren Hospital | OTHER |
| Xuanwu Hospital, Beijing | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bypass | Experimental | Patients presenting with long occlusion of the superficial femoral artery enrolled in bypass arm will undergo suprageniculate femoropopliteal bypass surgery to bypass the occluded superficial femoral artery. And the graft will be artificial blood vessel. |
|
| stent | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stent | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occlusion of the stent or artificial blood vessel bypass | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure. | 30 days |
| Rate of limb salvage | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Changwei, bachelor | Contact | 86-010-88068230 | liucw@vip.sina.com | |
| Ye Wei, doctor | Contact | 86-010-88068230 | yewill18@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Liu Changwei, bachelor | Study Chair | |
| Ye Wei, doctor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100032 | China |
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| Label | URL |
|---|---|
| the website of the vascular surgery department of PUMCH | View source |
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| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000089802 | Chronic Limb-Threatening Ischemia |
| C564658 | Peripheral Arterial Occlusive Disease 1 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| femoral-popliteal bypass with artificial blood vessel | Device | Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses. |
|
| Procedural complications, defined as any adverse event | including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula | 36 months |
| Quality of Life assessment | assessment in 1 month,6 months,12 months,24 months and 36 months post procedure | 36 months |
| Rate of amputation | 36 months |
| Increase in Ankle Brachial Index | 36 months |
| Restenosis measured by Duplex Ultrasound or CTA | 36 months |
| Xuanwu Hospital, Beijing | Recruiting | Beijing | Beijing Municipality | 100053 | China |
|
| Beijing Tongren Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
|
| D016491 |
| Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |