Safety and Effectiveness Evaluation of Eximo Medical's B-Laser™ Atherectomy Device, in Subjects Affected With Infrainguinal PAD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 22
- 主要终点
- Acute Technical Success
研究概览
简要总结
This is a prospective, single-arm, multi-center, international, open-label, clinical study.
详细描述
The aim of the study is to assess the safety and efficacy of the Eximo Medical's B-Laser™ Atherectomy catheter in subjects with infrainguinal Peripheral Artery Disease (PAD).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 18 years old.
- •Subject is a candidate for atherectomy for infrainguinal peripheral artery disease.
- •Documented symptomatic atherosclerotic peripheral artery disease Rutherford Classification 2-
- •Subject has an infrainguinal target lesion(s) with any type of stenosis (naïve recurrent, or in-stent) estimated to be ≥70% based on CT angiogram or any other imaging modality.
- •Subject is capable and willing to comply with the scheduled follow up
- •Subject or appropriate legal surrogate is able and willing to sign a written Informed Consent Form (ICF).
- •Intraoperative inclusion criteria (by fluoroscopy angiogram):
- •Target lesion has a stenosis estimated to be ≥70%.
- •In ATK subjects - at least one patent tibial run-off vessel into the foot
排除标准
- •Target lesion is in a vessel graft or synthetic graft.
- •Target lesion length <1cm and >15 cm (in ISR cases could be >25cm).
- •Endovascular or surgical procedure in the target limb performed less than or equal to 30 days prior to the index procedure OR Planned endovascular or surgical procedure 30 days after the index procedure.
- •Intent to use other atherectomy device in the same procedure.
- •Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
- •Evidence or history of aneurysm in the target vessel within the past 2 months.
- •History of bleeding diathesis, coagulopathy or inability to accept blood transfusions.
- •History of heparin-induced thrombocytopenia (HIT) or inability to tolerate antiplatelet medication(s), anticoagulation, or thrombolytic therapy.
- •Subjects requiring dialysis.
- •Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
- •Serious illness that may affect subject compliance to protocol and 30-day follow-up.
- •Participating in another clinical study
- •Subject is pregnant or planning to become pregnant during the study period.
- •Life expectancy < 12 months
- •Any planned amputation above the ankle.
- •Intraoperative exclusion criteria (by fluoroscopy angiogram):
- •Inability to intraluminally cross and secure a 0.014" wire across the target lesion.
- •Target lesion length <1cm and >15 cm (in ISR cases >25cm).
- •Reference vessel lumen diameter proximal to target lesion is <150% of the outer diameter of the B-LaserTM.
- •Any clinical and/or angiographic complication prior to the planed insertion of B-laser™.
研究组 & 干预措施
B-Laser™ Atherectomy System
B-Laser™ Atherectomy System
干预措施: B-Laser™ Atherectomy System (Device)
结局指标
主要结局
Acute Technical Success
时间窗: Perioperative
Reduction from baseline in residual diameter stenosis (%), prior to any adjunctive therapy, achieved by the B-Laser™ catheter A change (always a reduction) between two time points (baseline time-point and post B-Laser treatment time-point, both perioperative) is reported: * As assessed quantitatively by the core laboratory. * This endpoint will be met if the mean reduction in residual diameter stenosis is greater than 20%. * A greater reduction means better results.
Number of Participants With Freedom From 30 Days Major Adverse Events (MAEs)
时间窗: 30 (+/-5) days post procedure
1. Unplanned target limb amputation above the ankle 2. Clinically Driven Target Lesion Revascularization (CDTLR) 3. Cardiovascular related deaths * As adjudicated by the Clinical Event Committee (CEC). * This endpoint will be met if the freedom from MAE rate is greater than 85%.
次要结局
- Number of Lesions With Freedom From Non-Clinically Significant [1] Device Related Adverse Events (AEs) in the Target Vessel(Perioperative and up to 30 (+/-5) days post procedure)
- Number of Lesions With Residual Stenosis by Angiography of ≤ 30% Post-procedure Including Any Adjunctive Therapy, With no Flow Limiting Dissection.(Perioperative)
- PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (1)(30 (+/-5) days post procedure)
- Number of Lesions With Freedom From Clinically Significant [1] Device Related Adverse Events (AEs) Requiring Intervention in the Target Vessel(Perioperative and up to 30 (+/-5) days post procedure)
- Number of Lesions With Clinical Success at 30 Days(30 (+/-5) days post procedure)
- PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (2)(30 (+/-5) days post procedure)