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.

NCT ID: NCT04801004

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2026-12-31

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 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.

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.

Conditions

Peripheral Arterial Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Tosaka III In-stent restenosis after stent implantation in PAD patients (Including acute and subacute thrombotic lesions).

2. Rutherford grade 2-5.

3. Stents should be located in the femoropopliteal artery.

4. The stenosis of iliac artery on the affected side is less than 30% or the residual stenosis after treatment is less than 30%.

5. Informed consent has been signed

Exclusion Criteria

1. Tosaka I or II in-stent restenosis.

2. Stents are located in iliac artery or artery below the knee, or the preoperative CTA showed type 3 or 4 stent fracture.

3. Rutherford Grade 6.

4. Thromboangiitis obliterans (TAO)-based, arteritis-based or connective tissue disorder-based FP-ISR.

5. Intraoperative conversion to hybrid or open surgery.

6. Patients refusing to sign informed consent forms.

7. Life expectancy of patients is less than 12 months.

8. The pregnant or nursing patients.

9. The patients with severe ischemia of lower extremity who would receive major amputation in plan.

10. Patients in whom antiplatelet or anticoagulant therapy is contraindicated.

11. Myocardial infarction or stroke within 3 months prior to enrolment.

12. Patient with known allergy to contrast agents or medications used to perform endovascular intervention.

13. Patients participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.

14. Patients who refuse to cooperate with long-term follow-up or who have difficulty communicating.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: collaborator

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role: collaborator

Qingdao Hiser Medical Group

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Liyuan Hospital of Tongji Medical College of Huazhong University of Science and Technology

UNKNOWN

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital, Fudan University

Shanghai, , China

Countries

China

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Other Identifiers

The FP-artery Restore study

Identifier Type: -

Identifier Source: org_study_id