NCT05971394招募中不适用
A Prospective, Multicentre, Single Arm Clinical 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
Biotyx Medical (Shenzhen) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年7月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Freedom from Primary Efficacy Failure
研究概览
简要总结
The goal of this prospective, multicentre, single arm clinical trial is 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. 100 participants will be implanted with IBS Titan™, and be followed up for 1-month, 6-month and 12-month after discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General criteria
- •Subject between 18 and 85 years old.
- •Subject who can understand the purpose of the trial, voluntarily participate in, and sign the informed consent form, and who are willing to participate until the 12 months follow-up.
- •Subject has symptomatic Critical Limb Ischemia, Rutherford category 3-
- •Subject requires primary treatment of de novo infrapopliteal lesions.
- •Angiographic criteria
- •Target lesion stenosis ≥ 70% or occlusion in no more than two infrapopliteal arteries.
- •The distal margin of the target lesion must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise.
- •The target lesion must be located in the proximal 2/3 of native infrapopliteal vessels, length is ≤ 200mm, with vessel diameter of 2.5-4 mm.
- •Only two infrapopliteal vessels are allowed to be treated at the same time.
- •A maximum of two stents can be deployed at one target vessel.
- •There must be at least one unimpaired artery (< 30% stenosis) to the ankle.
排除标准
- •General criteria：
- •Severe renal insufficiency, hepatic dysfunction (Cr > 2 times normal limit or renal dialysis, ALT or AST > 5 times normal limit).
- •Major amputation before index procedure or plan for major amputation.
- •Any coagulation disorder.
- •Lower extremity arteries surgery or thrombolytic therapy in the ipsilateral extremity in the past 6 weeks.
- •Stroke within 3 months, or stroke with severe hemiplegia and aphasia sequelae more than 3 months before inclusion in the study.
- •Acute myocardial infarction or acute ischemia within 30 days before inclusion in the study.
- •Thromboangiitis obliterans (Buerger's disease).
- •Any previous treatment with drug eluting balloon or drug eluting stent within 90 days before inclusion.
- •Any surgery in target vessel before index procedure.
- •Volume reduction operation in target vessel before inclusion.
- •Subject known to be allergic to aspirin, heparin, clopidogrel, Polylactic acid, iron, zinc and its degradation products, contrast agents, sirolimus, etc., and those who cannot tolerate postoperative dual anti-platelet therapy.
- •Subject with a history of iron overload or iron disorders related diseases, such as hereditary hemochromatosis, etc.
- •Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
- •Women of child-bearing potential not using an effective contraception; pregnant or lactating women.
- •Subject is not suitable to participate in the trial as per investigators discretion.
- •Life expectancy ≤ 12 months as per investigators judgement.
- •Angiographic criteria
- •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.
- •Significant stenosis (≥50% stenosis) of the arterial outflow tract perfused by the target vessel.
- •In-stent restenosis in any lower extremity artery.
- •Thrombosis in target vessel, or acute thrombosis requiring thrombolysis and thrombectomy.
- •Guide wire cannot pass target lesion.
- •Angiography suggests intraoperative thromboendarterectomy, percutaneous transluminal rotational atherectomy or laser therapy are needed.
- •Aneurysm of lower extremity artery in the ipsilateral leg.
结局指标
主要结局
Freedom from Primary Efficacy Failure
时间窗: 6 months
Defined as freedom from the composite of total occlusion of target lesion and clinically driven target lesion revascularization (CD-TLR), and freedom from major amputation.
次要结局
- Rate of Technical success(Immediately post-procedure)
- Incidence of Target lesion restenosis(1 month, 6 months, 12 months)
- Change in Rutherford Category compared to baseline (before treatment)(1 month, 6 months, 12 months)
- Change in ankle-brachial index (ABI) compared to baseline (before treatment)(1 month, 6 months, 12 months)
- Major adverse event (MAE)(1 month, 6 months, 12 months)
- Rate of Device success(Immediately post-procedure)
- Rate of Procedural success(Immediately post-procedure)
研究者
研究点 (1)
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