Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04801004
Status:
RECRUITING
Last Update Posted:
2022-10-28
First Post:
2021-03-10
Brief 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
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FP-Restore
Brief 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 restenosisIt 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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None