Status:
UNKNOWN
IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease
Lead Sponsor:
Biotyx Medical (Shenzhen) Co., Ltd.
Conditions:
Critical Limb Ischemia (CLI)
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
A prospective, multi-center, randomized trial to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopl...
Eligibility Criteria
Inclusion
- Patients must between 18 and 85 years old, without gender limit.
- Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and complete the 1-year follow-up.
- Subject has lower extremity atherosclerotic occlusive disease with symptomatic Critical Limb Ischemia (CLI).
- Rutherford Becker Clinical Category 3-5.
- The target lesion is below the popliteal artery (including bifurcation).
- The target lesion is located in the proximal 2/3 of native infrapopliteal vessels or tibiofibular trunk.
- The target lesion stenosis is ≥70% or occlusion of no more than two infrapopliteal arteries (including the anterior and/or posterior tibial and/or peroneal artery and/or tibiofibular trunk).
- The length of target lesion is ≤200mm, which could be covered by no more than two stents, with vessel diameter of 2.25-4.25 mm.
Exclusion
- Severe renal insufficiency, hepatic dysfunction (Cr\>2 times of normal limit or renal dialysis, ALT or AST \> 5 times of normal limit).
- Surgery in target vessel before treatment.
- Volume reduction surgery in target vessel before treatment.
- Thrombosis in target vessel, or acute thrombosis requiring thrombolysis and thrombectomy.
- Systematic coagulation disorder or hypercoagulability.
- Lower extremity arteries surgery or thrombolytic therapy in the ipsilateral extremity in the past 6 weeks.
- Stroke occurs within 3 months before surgery, or stroke occurs with severe hemiplegia aphasia sequelae more than 3 months before treatment.
- Acute myocardial infarction or angina pectoris within 30 days before treatment.
- In-stent restenosis.
- Guide wire cannot pass target lesion.
- Previously treated with drug eluting balloon within 1 year before treatment.
- More than two infrapopliteal arteries needed treatment.
- The inflow tract (including ipsilateral iliac artery, femoral artery, popliteal artery) has lumen stenosis \>30% with or without intervention.
- The inflow tract (including ipsilateral iliac artery, femoral artery, popliteal artery) has \> 150 mm stenosis or occlusion before treatment.
- Aneurysm of lower extremity artery.
- Thromboangiitis obliterans (Buerger's disease).
- Significant (≥ 50% stenosis) lesion in a distal outflow artery that would be perfused by the target vessel and that requires treatment at the time of the index procedure.
- Patients known to be allergic to aspirin, heparin, Plavix, contrast agents, Sirolimus, poly lactic acid polymer, iron, zinc and their degradation product, and those who cannot tolerate postoperative dual anti-platelet therapy.
- Patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc.
- Patients who are participating in another clinical trial that has not yet completed its primary endpoint.
- Pregnant or those who plan pregnancy during the clinical investigation follow-up period.
- Angiography suggests intraoperative thromboendarterectomy, percutaneous transluminal rotational atherectomy or laser therapy are needed.
- Patients have life expectancy ≤ 1 year.
- Patients who are not suitable for participating the trial judged by investigator.
Key Trial Info
Start Date :
December 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04849325
Start Date
December 9 2021
End Date
October 1 2024
Last Update
March 17 2022
Active Locations (29)
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1
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
2
Beijing Hospital
Beijing, China
3
Beijing Tsinghua Changgung Hospital
Beijing, China
4
Peking Union Medical College Hospital
Beijing, China