PATHFINDER Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease (EX-PAD-05)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 15
- 主要终点
- Primary Safety: Freedom from Peri-procedural major adverse events (PPMAE)
研究概览
简要总结
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term) of the AURYON Atherectomy System, within the initial launch phase of the product in the market.
详细描述
US multicenter, prospective, single-arm, observational post market Registry. A pilot registry aimed to evaluate the safety and efficacy of Auryon Atherectomy System in the treatment of de novo, re-stenotic and ISR lesions in infra-inguinal arteries of Peripheral Artery Diseases (PAD) subjects, in a real-world setting within the initial launch phase of the product in the market.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 infra-inguinal peripheral artery disease.
- •Documented symptomatic atherosclerotic peripheral artery disease with claudication or critical limb ischemia (CLI) (Rutherford Classification 2-5 ).
- •Subject is capable and willing to comply with the scheduled follow up
- •Subject is able and willing to sign a written Informed Consent Form (ICF).
排除标准
- •Target lesion is in an arterial bypass.
- •Planned use of another atherectomy device in the same procedure
- •Co-morbid condition(s) with less than 1yr anticipated survival that could limit the subject's ability to participate in the trial or to comply with follow-up requirements or impact the scientific integrity of the study.
- •Participating in another study on an interventional non-cleared device, that could impact the study results
结局指标
主要结局
Primary Safety: Freedom from Peri-procedural major adverse events (PPMAE)
时间窗: Till discharge, an average of 5 days
Percentage of subjects with freedom from peri-procedural major adverse events (PPMAE), defined as (a) flow-limiting dissection, (b) clinically significant distal embolization, (c) bailout stenting, (d) major/unplanned amputation, (e) target vessel perforation requiring endovascular or surgical repair or (f) death, till discharge.
Primary Efficacy: Acute Procedural Success
时间窗: Peri-procedural (by the end of the index procedure)
Percentage of lesions with successful revascularization of target vessel defined as ≤30% residual stenosis at the treated lesion post Auryon atherectomy and final adjunctive treatment (if required), as evaluated by angiographic corelab.
次要结局
- Rate of device related complications requiring intervention(Till discharge, an average of 5 days)
- Rates of MAEs over time(Post-discharge (at 30-days, 6-, 12-, and 24-months))
- Patency rate(Post-discharge (at 6-, 12-, and 24-months))
- Occlusion freedom(Post-discharge (at 6-, 12-, and 24-months))
- Clinical outcome 1 - ankle brachial index (ABI)(Post-discharge (at 6-, 12-, and 24-months))
- Clinical outcome 2 - walking impairment questionnaire (WIQ)(Post-discharge (at 6-, 12-, and 24-months))
- Clinical outcome 3 - Rutherford clinical categories (RCC)(Post-discharge (at 6-, 12-, and 24-months))