NCT04849325RecruitingNot Applicable
A Prospective, Multi-Center, Randomized Trial Comparing the IBS Titan™ Sirolimus-Eluting Iron Bioresorbable Peripheral Scaffold System vs. Standard Balloon Angioplasty for Treatment of Below-the-Knee Arteries: GENIUS TRIAL
Biotyx Medical (Shenzhen) Co., Ltd.29 sites in 1 country120 target enrollmentStarted: December 9, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 29
- Primary Endpoint
- Primary Patency Rate
Study Overview
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 infrapopliteal arterial stenosis or occlusive disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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-
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Primary Patency Rate
Time Frame: 180 days
Defined as freedom from total occlusion of target lesion and clinically driven target lesion revascularization (CD-TLR) of target lesion, and freedom from major amputation.
Secondary Outcomes
- All-cause mortality(30 days, 180 days, 365 days)
- Incidence of Target lesion restenosis(30 days, 180 days, 365 days)
- Change in ankle-brachial index (ABI) compared to baseline (before treatment)(30 days, 180 days, 365 days)
- Incidence of major amputation(30 days, 180 days, 365 days)
- Rate of Device Success(Immediately after the procedure)
- Rate of Participants with Technical Success(Immediately after the procedure)
- Rate of Participants with Procedural Success(Immediately after the procedure)
- Wound healing rate of ulcer patients(30 days, 180 days, 365 days)
- Late Lumen Loss(180 days)
- Change in Rutherford-Becker category compared to baseline (before treatment)(30 days, 180 days, 365 days)
- Incidence of Clinically-driven Target Vessel Revascularization (CD-TLR)(30 days, 180 days, 365 days)
Investigators
Study Sites (29)
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