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|
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : October 28, 2022
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|Condition or disease|
|Peripheral Arterial Disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|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|
- 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.
- 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|
- 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
- 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.
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
|Contact: Zhenyu Shi, MD,PhDfirstname.lastname@example.org|
|Zhongshan Hospital, Fudan University||Recruiting|
|Contact: Zhenyu Shi, PhD|
|Responsible Party:||Shanghai Zhongshan Hospital|
|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|
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases