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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms

  • Femoropopliteal Occlusive Disease

NCT number NCT04698304
Study type Observational
Source RenJi Hospital
Contact Ni Qihong, M.D.
Phone +8615801900772
Email niqihong1989@163.com
Status Recruiting
Phase
Start date January 1, 2021
Completion date December 31, 2025

See also
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Completed NCT03414515 - Endovascular Treatment of Peripheral Artery Disease (PAD)
Withdrawn NCT01884701 - Accessing Peripheral Occluded LesiOns II (APOLO-II) Phase 3
Completed NCT02939924 - Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Kanshas Paclitaxel-coated Balloon Catheter. N/A
Recruiting NCT01514916 - New Anastomotic Device for End to End Vascular Anastomosis in the Treatment of Peripheral Vascular Disease N/A