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. (FP-Restore)

October 26, 2022 updated by: Shanghai Zhongshan Hospital
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients with Tosaka III in-stent restenosis lower extremity femoropopliteal artery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from clinically-driven TLR
Time Frame: 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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary patency
Time Frame: 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.
1month, 6 months,12 months, 18 months ,24 months
Technical success rate
Time Frame: 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.
30 days
Incidence of major adverse events.
Time Frame: 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.
1month, 3 months,6 months, 12 months ,24 months
Freedom from TLR
Time Frame: 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.
1month, 6 months,12 months, 18 months
Vascular quality of life questionnaire(VascuQol)
Time Frame: 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.
3 months,6 months, 12 months ,24 months
Health economics evaluation
Time Frame: 24months
All the cost related to the target vessel and spent in the inpatient ward will be recorded and analyzed.
24months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

First People's Hospital of Hangzhou
RenJi Hospital
Chengdu University of Traditional Chinese Medicine
Xuanwu Hospital, Beijing
First Affiliated Hospital of Zhejiang University
Second Affiliated Hospital of Soochow University
Qingdao Hiser Medical Group
Liyuan Hospital of Tongji Medical College of Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 14, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

October 28, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The FP-artery Restore study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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