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A Real-world Study to Evaluate the Primary Patency and Freedom From TLR of Endovascular Treatment in TOSAKA III In-stent Restenosis of Lower Extremity Femoropopliteal Artery. — FP-Restore  

Peripheral Arterial Disease Clinical Trial

Official title:
A Real-world Study to Evaluate the Primary Patency and Freedom From TLR of Endovascular Treatment in TOSAKA III In-stent Restenosis of Lower Extremity Femoropopliteal Artery.

Clinical Trial Summary

This study is a prospective, multi-center, real world, observational study, which aims at evaluating the safety, efficacy and economic cost of endovascular treatments for endovascular therapies in tosaka III (totally occluded) in-stent restenosis.It is estimated that 300 subjects diagnosed with tosaka III in-stent restenosis and receive endovascular treatments will be enrolled in nine centers from April 2021 to December 2022 nation-widely. All the subjects will be under follow-up for 24 months. There is no restriction on the endovascular techniques. The primary outcomes include clinical-driven freedom from TLR at 24 months.

Clinical Trial Description

In-stent restenosis was a series of complications of treatment in peripheral artery disease, which lead the fluid of lower extremity re-limited even chronic limb ischemia and amputation. Its typical symptoms were recurrent claudication, rest pain and ischemic. Tosaka III in-stent restenosis, which also called in-stent occlusion was one of the most serious of this kind of complications. Its symptoms usually more severe and irreversible, and its treatments were complicated and challenging. The efficacy of single balloon angioplasty is limited. New devices including drug-coated balloon, intravascular Lithotripsy, directional atherectomy, laser debulking devices and stent-grafts offer another chance and better prognosis. The data of these new devices, however, are mainly from low-quality evidence. Therefore, we start this prospective, multicenter, real-world, observational study, providing new data on the safety, efficacy and health economics evaluation of endovascular treatments for Tosaka III in-stent restenosis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04801004
Study type Observational [Patient Registry]
Source Shanghai Zhongshan Hospital
Contact Zhenyu Shi, MD,PhD
Phone +86021-64041990
Email shizhenyumax@163.com
Status Recruiting
Phase
Start date April 1, 2021
Completion date December 31, 2024
View Details
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