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. (FP-Restore)

  • End date
    Dec 31, 2024
  • participants needed
  • sponsor
    Shanghai Zhongshan Hospital
Updated on 2 May 2022
in stent restenosis


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 the rate of primary patency and freedom from TLR at 3,6,12,24 months.


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.

Condition Peripheral Arterial Disease
Clinical Study IdentifierNCT04801004
SponsorShanghai Zhongshan Hospital
Last Modified on2 May 2022


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Inclusion Criteria

Tosaka III In-stent restenosis after stent implantation in PAD patients. (including acute and subacute thrombotic lesions)
The length of occluded lesion is greater than or equal to 5cm
Stent location: the stent should be located in the femoralpopliteal artery , and the preoperative CTA showed no type 3 or 4 stent fracture
Rutherford grade 2-5, symptoms of lameness or resting pain or localized gangrenous ulcer
The stenosis of iliac artery on the affected side is less than 30% or the residual stenosis after primary treatment is less than 30%
Sign the relevant informed consent

Exclusion Criteria

Tosaka I or II in-stent stenosis or occlusion lesion less than 5cm in length
Stents are located in iliac artery, or artery bellow the knee
Rutherford Grade 6
TAO based, arteritis-based or connective tissue disorder-based ISR
Intraoperative conversion to hybrid or open surgery
Patients who refuse to sign informed consent
Life expectancy of patients is less than 24 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 enrollment
Patient has known allergy to contrast agents or medications used to perform endovascular intervention lead to operation interrupted
Patient is 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 sign informed consent
Patients who refuse to cooperate with long-term follow-up after surgery, or who have difficulty communicating for personal reasons for quality of life assessment
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