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| Name | Class |
|---|---|
| Xuanwu Hospital, Beijing | OTHER |
| Second Affiliated Hospital of Suzhou University | OTHER |
| Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology | OTHER |
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Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, more challenging femoropopliteal arterial lesions have been treated with endovascular procedures.
The TASC D lesion ,especially with popliteal artery involved are often excluded in prospective clinical trials. Therefore, a well-designed real world study that track clinical relevant outcomes, are required to determine the optimal therapies for patients with complex femoropopliteal lesions.
According to the TASC II guidelines, TASC D lesions was recommended for primary endovascular revascularization, TASC C lesions for surgical revascularization in patients with appropriate perioperative risk and available conduit. However, Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, more challenging femoropopliteal arterial lesions have been treated with endovascular procedures.
Despite The shift of Endovascular- first strategy has been documented in recent literature. There still lack evidence to support either approach have a significant advantage over the other. And TASC D lesion ,especially with popliteal artery involved are often excluded in prospective clinical trials. Therefore, a well-designed real world study that track clinical relevant outcomes, are required to determine the optimal therapies for patients with complex femoropopliteal lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A:TASC C lesion group | Multiple stenoses or occlusions totaling >15cm or recurrent stenoses or occlusions that need treatment after endovascular interventions (300 cases) |
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| Group B:TASC D lesion with common femoral artery involved | Chronic total occlusions >20cm with common femoral artery involved (100 cases) |
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| Group C:TASC D lesion with proximal popliteal artery involved | Chronic total occlusions >20cm with proximal popliteal artery involved (300 cases) |
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| Group D:TASC D lesion with distal popliteal artery involved | Chronic total occlusions >20cm with distal popliteal artery involved (200 cases) |
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| Group E:TASC D lesion with popliteal artery and proximal trifurcation vessels involved | Chronic total occlusion of popliteal artery (P1-3 segment) with proximal trifurcation vessels involved (100 cases) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endovascular treatment | Procedure | All the patients are treated by endovascular therapy, through contralateral femoral artery approach, ipsilateral antegrade femoral artery approach or brachial artery approach. If the lesion is difficult to pass in antegrade approach, retrograde puncture at the distal artery of the lesion can be performed. Surgeons can choose treatment methods according to the characteristics of the lesions. For example: (a) Plain old balloon angioplasty; (b) Drug-coated balloon angioplasty; (c) Drug-coated balloon angioplasty + provisional stenting; (d) Bare-metal stent implantation; (e) Stent graft implantation; (f) Directional atherectomy + drug-coated balloon angioplasty, (g) Drug -eluting stent. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Technical success refers to 1. Establishment of continuous blood flow, no early occlusion, acute thrombosis or reintervention driven by target lesion within 7 days after operation | 7 days |
| Incidence of major adverse events | major adverse events | 36 months |
| Target vessel patency rate evaluated by postoperative ultrasound | Target vessel patency rate | 36 months |
| Clinical-driven Target lesion reintervention rate | Target lesion reintervention rate | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical-driven Target lesion reintervention rate | Target lesion reintervention rate | 24 months |
| Direct medical expenses (3-year cumulative hospitalization expenses and endovascular expenses related to target lesions) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with TASC C, D femoropopliteal lesions who undergoing endovascular treatment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Shanghai | Shanghai Municipality | 200127 | China |
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| Chengdu University of Traditional Chinese Medicine | OTHER |
| First Affiliated Hospital of Zhejiang University | OTHER |
| Xiamen Cardiovascular Hospital, Xiamen University | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Huashan Hospital | OTHER |
| Qingdao Haici Hospital | OTHER |
| First People's Hospital of Hangzhou | OTHER |
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Direct medical expenses
| 36 months |