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.

Recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT04801004
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-14
• Study First Posted: 2021-03-16
• Study Start: 2021-04-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-28
• Primary Completion: 2022-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from clinically-driven TLR	24 months	CD-TLR was defined as any reintervention within the target lesion(s) because of recurrent symptoms. Freedom form CD-TLR were defined as the rates of the number of patients who did not receive reintervention verse the number of patients during the follow-up period.

Secondary Outcome Measures

Name	Time	Method
Primary patency	1month, 6 months,12 months, 18 months ,24 months	The primary patency rate was defined as the percentage of stent patency examined by DUS or CTA examination of lower limb arteries during follow-up.
Freedom from TLR	1month, 6 months,12 months, 18 months	TLR was defined as a reintervention performed for \>50% diameter stenosis or in the target lesion after documentation of recurrent clinical symptoms following the index procedure or bailout stenting during the index procedure. Freedom form TLR were defined as the rates of the number of patients who did not receive reintervention verse the number of patients during the follow-up period.
Technical success rate	30 days	Successfully revascularize the target vessel. The residual stenosis is \<30% and there is no acute thrombosis occurred in the target vessel within 30 days post-operation. The Technical success rate was defined as the rate of the number of patients who receive the treatment as intended verse the number of the patients enrolled.
Incidence of major adverse events.	1month, 3 months,6 months, 12 months ,24 months	Major adverse events include anyone of the following: all-cause mortality, Myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology, and arterial thrombosis related to endovascular manipulation.
Vascular quality of life questionnaire(VascuQol)	3 months,6 months, 12 months ,24 months	The VascuQol was designed as a questionnaire containing five domains: pain (4 items), symptoms (4 items), activities (8 items), social (2 items), and emotional (7 items) to evaluate Health related quality of life (HRQL). Every item has seven response options, with scores ranging from 1 to 7. A total score is the sum of all 25 item scores divided by 25.And both the total score as well as the domain scores range from 1 (worst HRQL) to 7 (best HRQL).The lower the value, the poorer the quality of life.
Health economics evaluation	24months	All the cost related to the target vessel and spent in the inpatient ward will be recorded and analyzed.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China