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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 II. This part is a multi-center, prospective, registration study which focuses on the treatment of below-knee arterial lesion. Totally 130 patients will be entered into this part. They should suffer ischemic symptom with Rutherford 3-6 for the occlusion of the below-knee arteries(anterior tibial、posterior tibial or peroneal artery). According to the lesion length, the patients will accept transluminal angioplasty or below-knee arterial bypass. They 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTA | Experimental | The patients with short-obstruction in the below-knee artery will be included in this group. |
|
| bypass | Experimental | The patients with long-obstruction in the below-knee artery will be included in this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Transluminal Angioplasty | Device | Before operation, take aspirin 100mg every day. During the operation, balloon is delivered by a catheter and positioned through the narrowing in the artery. Then expand the balloon against the wall of the blood vessel to provide a wider channel for blood. |
| Measure | Description | Time Frame |
|---|---|---|
| Occlusion of the below-knee artery 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 |
|---|---|
| D017130 | Angioplasty |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
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|
| below-knee arterial bypass | Device | Before operation, take aspirin 100mg every day. Perform bypass to below-knee(posterior tibial,anterior tibial or peroneal)arteries, saphenous vein 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 |
| Restenosis measured by Duplex Ultrasound or CTA | 36 months |
| Beijing |
| Beijing Municipality |
| 100053 |
| China |
| Beijing Tongren Hospital | Beijing | Beijing Municipality | Beijing | 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 |
| D013504 |
| Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |