Status:
ACTIVE_NOT_RECRUITING
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.
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
RenJi Hospital
First Affiliated Hospital of Zhejiang University
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
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 tos...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
- Patients refusing to sign informed consent forms.
- Life expectancy of patients is less than 12 months.
- The pregnant or nursing patients.
- The patients with severe ischemia of lower extremity who would receive major amputation in plan.
- Patients in whom antiplatelet or anticoagulant therapy is contraindicated.
- Myocardial infarction or stroke within 3 months prior to enrolment.
- Patient with known allergy to contrast agents or medications used to perform endovascular intervention.
- Patients participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
- Patients who refuse to cooperate with long-term follow-up or who have difficulty communicating.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04801004
Start Date
April 1 2021
End Date
December 31 2026
Last Update
September 2 2025
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, China