A Real-world Study to Evaluate the Primary Patency and Freedom From TLR of Endovascular Treatment… (NCT04801004) | Clinical Trial Compass
CompletedNot Applicable
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.
China322 participantsStarted 2021-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Tosaka III In-stent restenosis after stent implantation in PAD patients (Including acute and subacute thrombotic lesions).
✓. Rutherford grade 2-5.
✓. Stents should be located in the femoropopliteal artery.
✓. The stenosis of iliac artery on the affected side is less than 30% or the residual stenosis after treatment is less than 30%.
✓. Informed consent has been signed
Exclusion criteria
✕. Tosaka I or II in-stent restenosis.
✕. Stents are located in iliac artery or artery below the knee, or the preoperative CTA showed type 3 or 4 stent fracture.
✕. Rutherford Grade 6.
✕. Thromboangiitis obliterans (TAO)-based, arteritis-based or connective tissue disorder-based FP-ISR.
✕. Intraoperative conversion to hybrid or open surgery.