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)
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| ClinicalTrials.gov Identifier: NCT04801004 |
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Recruitment Status :
Recruiting
First Posted : March 16, 2021
Last Update Posted : October 28, 2022
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Sponsor:
Shanghai Zhongshan Hospital
Collaborators:
RenJi Hospital
First Affiliated Hospital of Zhejiang University
Chengdu University of Traditional Chinese Medicine
Xuanwu Hospital, Beijing
First People's Hospital of Hangzhou
Qingdao Hiser Medical Group
Second Affiliated Hospital of Soochow University
Liyuan Hospital of Tongji Medical College of Huazhong University of Science and Technology
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital
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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.
| Condition or disease |
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| Peripheral Arterial Disease |
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 [Patient Registry] |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 3 Months |
| Official Title: | 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. |
| Actual Study Start Date : | April 1, 2021 |
| Estimated Primary Completion Date : | December 31, 2022 |
| Estimated Study Completion Date : | December 31, 2024 |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Study Population
The patients with Tosaka III in-stent restenosis lower extremity femoropopliteal artery.
Criteria
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.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04801004
Contacts
| Contact: Zhenyu Shi, MD,PhD | +86021-64041990 | shizhenyumax@163.com |
Locations
| China | |
| Zhongshan Hospital, Fudan University | Recruiting |
| Shanghai, China | |
| Contact: Zhenyu Shi, PhD | |
Sponsors and Collaborators
Shanghai Zhongshan Hospital
RenJi Hospital
First Affiliated Hospital of Zhejiang University
Chengdu University of Traditional Chinese Medicine
Xuanwu Hospital, Beijing
First People's Hospital of Hangzhou
Qingdao Hiser Medical Group
Second Affiliated Hospital of Soochow University
Liyuan Hospital of Tongji Medical College of Huazhong University of Science and Technology
Publications of Results:
Other Publications:
Other Publications:
| Responsible Party: | Shanghai Zhongshan Hospital |
| ClinicalTrials.gov Identifier: | NCT04801004 |
| Other Study ID Numbers: |
The FP-artery Restore study |
| First Posted: | March 16, 2021 Key Record Dates |
| Last Update Posted: | October 28, 2022 |
| Last Verified: | October 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Shanghai Zhongshan Hospital:
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in-stent restenosis |
Additional relevant MeSH terms:
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Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |