A First-in-human, Single-arm, Single-center, Feasibility Study 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
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Technical Success (On Procedure Day)
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
A first-in-human, single-arm, single-center, feasibility 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 10 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
- •The patient, or the patient's legal guardian has 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 confirmation of a de novo, CTO, infrainguinal ligament including above the knee, below the knee, or below the ankle vessels.
排除标准
- •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.
- •Evidence of active infection, including but not limited to the target limb.
- •Current use of cocaine or other substance 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 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.
- •Platelet count < 50,000.
结局指标
主要结局
Technical Success (On Procedure Day)
时间窗: Day 1
Ability of the FastWire to successfully cross angiographically confirmed chronic total occlusions and provide a platform for delivery of other treatment devices.
Clinical success (On Procedure Day)
时间窗: Day 1
Clinical success is assessed as the angiographically confirmed passage of the FastWire tip through the lesion and the successful delivery and retrieval of FastWire and the delivery of a treatment device to the target site.
Freedom from Serious Adverse Events related to the use of FastWire, at 30 days post procedure:
时间窗: Up to Day 30
* Cardiovascular deaths. * Vessel dissection requiring an intervention to resolve. * Unplanned index limb amputation. * Symptomatic distal embolization.
次要结局
- Freedom from Serious Adverse Device Effects (SADE) (Up to Day 30)(Up to Day 30)
- Procedural success (On Procedure Day)(Day 1)
- Procedure related mortality (Up to Day 7 & Day 30)(Up to Day 7 & Day 30)
- Freedom from Vessel dissection or bleeding (Within 24 Hours)(Within 24 Hours)