A Pivotal, Single-arm, Multi-centre, Prospective Clinical Investigation to Assess the Efficacy and Safety of the FastWire REvascularisation of Extremities, (For LOWer Limbs) (FREEFLOW).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 65
- 试验地点
- 12
- 主要终点
- Clinical success (On Day of Procedure)
研究概览
简要总结
This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs)
详细描述
Single-arm, multi-center, pivotal study to assess the efficacy and safety of the FastWire System in patients who have a chronic total occlusion in their peripheral vasculature causing an ischemic limb. The enrollment will consist of up to 65 patients meeting the inclusion/exclusion criteria.
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 Inclusion Criteria: Subjects who meet all the following criteria are eligible for this clinical investigation:
- •The patient signed and dated an Informed Consent Form.
- •Aged between 18 years and 85 years (inclusive).
- •Severe claudication assessed as Rutherford category 3 or CLTI assessed as Rutherford category 4 or 5 LEAD.
- •Angiographic Inclusion Criteria
- •Unless otherwise specified, the Investigator performing the procedure bases angiographic inclusion on the visual determination of qualification imaging taken at the time of the procedure. Subject must meet ALL the following angiographic inclusion criteria:
- •Angiographic confirmation at the time of the procedure of a de novo CTO below the origin of the superficial femoral artery (SFA) including above the knee or below the knee. (Note: Multilevel CTOs are included as long as the total length from the beginning of the most proximal total occlusion to the end of the most distal total occlusion is less than 40 cm.)
- •100% stenosis by a visual estimate of angiography at the time of procedure.
- •For below-the-knee CTOs, the target limb shall have at least one patent (<50% stenosis) run-off vessel confirmed by angiography or magnetic resonance angiography at the time of the procedure.
排除标准
- •Subjects who meet any of the following criteria are not eligible for this clinical investigation:
- •Life expectancy of less than 12 months.
- •Females who are pregnant or lactating (urine test for women of childbearing age).
- •Myocardial infarction or stroke in two months prior to the index procedure.
- •Known, unstable coronary artery disease or other, uncontrolled comorbidity.
- •Any known haemorrhagic or coagulation deficiency.
- •Known sensitivity to nickel, titanium, or their alloys.
- •Evidence of active infection, including but not limited to the target limb.
- •Current use of cocaine or other substances of abuse.
- •Patients who have received any thrombolytic therapy in the last two weeks.
- •History of severe allergy or contraindication, to contrast medium or other medications used during or after endovascular therapy.
- •Subject participating in another study involving an investigational drug or device.
- •Patient has surgery or vascular intervention planned within 30 days of the index procedure.
- •Patient has had a previous peripheral bypass that includes the target vessel.
- •Patient has had a previous intervention in the target CTO (angioplasty, stenting) including previous attempt at time of index procedure.
- •Patient tests positive for coronavirus disease (COVID-2019), as per site standard practice.
- •Estimated Glomerular Filtration Rate (eGFR) of less than 30 ml/min or creatine level >2.5mg/ml.
- •Platelet count < 50,000/μL.
- •Angiographic Exclusion Criteria
- •Unless otherwise specified, the Investigator performing the procedure bases angiographic exclusion on a visual determination of qualification imaging taken at the time of the procedure. Subject is excluded if ANY of the following angiographic exclusion criteria is met:
- •For below-the-knee CTOs, a target limb without at least one patent (<50% stenosis) run-off vessel confirmed by angiography or magnetic resonance angiography at the time of the procedure.
- •Has an acute or sub-acute intraluminal thrombus within the target vessel.
- •Aneurysm distal to puncture access site at least twice the reference vessel diameter, located in the index vessel, abdominal aorta, iliac, or popliteal.
- •Has perforation, dissection, or other injury of the access site or index vessel requiring stenting or surgical intervention prior to attempting crossing of the target lesion with the FastWire System.
研究组 & 干预措施
FastWire System - Peripheral
This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs).
干预措施: FastWire System - Peripheral (Device)
结局指标
主要结局
Clinical success (On Day of Procedure)
时间窗: Day 1
Ability to facilitate treatment of the target lesion using the FastWire as a crossing device only and by allowing additional devices to cross the CTO as required. This will be angiographically confirmed.
Freedom from Serious Adverse Events
时间窗: Up to Day 30
Freedom from Serious Adverse Events related to the use of the FastWire System, at 30 days post procedure: * Cardiovascular deaths. * Vessel dissection (Grade C or greater) requiring an intervention to resolve. * Unplanned index limb amputation. * Symptomatic distal embolization is defined as clinical signs or symptoms of distal emboli detected in the treated limb distal to the treated lesion after the index procedure or noted angiographically after the index procedure and requiring mechanical or pharmacologic means to improve flow.
次要结局
- Technical success (On Day of Procedure)(Day 1)
- SADE (Up to Day 30)(Up to Day 30)
- Vessel dissection or bleeding (Within 24 Hours, Max 36 hrs)(Within 24 Hours, Max 36 hrs)
- Traverse the CTO (On Day of Procedure)(Day 1)
- Procedural success (On Day of Procedure)(Day 1)
- Procedure-related mortality (Up to Day 7 & Day 30)(Up to Day 7 & Day 30)