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| Name | Class |
|---|---|
| Beijing Tongren Hospital | OTHER |
| Xuanwu Hospital, Beijing | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bypass | Experimental | femoral-popliteal bypass |
|
| stent | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| femoral-popliteal bypass | Device | Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occlusion of the stent or 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 | Affiliation | Role |
|---|---|---|
| Liu changwei, bachelor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100032 | China | ||
| Xuanwu Hospital, Beijing |
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| Label | URL |
|---|---|
| the website of the vascular surgery department of PUMCH | View source |
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| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D003920 | Diabetes Mellitus |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| 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. |
|
| 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 |
| Restenosis measured by Duplex Ultrasound or CTA | 36 months |
| Beijing |
| Beijing Municipality |
| 100053 |
| China |
| Beijing Tongren Hospital | Beijing | Beijing Municipality | 100730 | China |
| D004700 | Endocrine System Diseases |
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |