A Prospective, Single-Arm, Multicenter, Feasibility Study to Evaluate Safety and Performance of the Amplitude Vascular System (AVS) Pulse Peripheral Intravascular Lithotripsy (IVL) for Treating Subjects With Calcific Femoropopliteal Arteries in Conjunction With Adjunctive Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 5
- 主要终点
- Device Success
研究概览
简要总结
The POWER-PAD-1 Study is a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter to enroll up to twenty (20) subjects.
详细描述
Amplitude Vascular System intendeds to conduct a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter in subjects with stenotic lesions of the superficial femoral and/or popliteal arteries (Rutherford Category 2 to 4 of the target limb) with a reference vessel diameter (RVD) of 4mm to 6mm and a total length of <60mm. Up to twenty subjects will be enrolled and treated with the Pulse IVL lithotripsy and followed for 6 months. The Pulse Intravascular Lithotripsy Catheter is intended for the pulsatile lithotripsy-enhanced balloon dilation of lesions, including calcified and fibro-calcific lesions in the peripheral vasculature, such as the superficial femoral and popliteal arteries.
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.
- •Subject is able and willing to comply with all assessments in the study.
- •Subject or subject's legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved consent form approved by the local Ethics Committee.
- •Rutherford clinical category 2, 3, or 4 of the target limb.
- •Resting ankle-brachial index (ABI) of ≤0.90, or ≤0.75 after exercise, of the target leg.
- •Moderate to severe calcification of target lesion(s) per pre-procedure CT scan. (Calcification must be: ≥180 degrees circumferential at some point in the lesion AND extend ≥50% length of lesion or absolute length ≥20mm.)
- •Flow-limiting target lesion reference vessel diameter is between 4.0mm and 6.5mm as determined by investigator
- •Target lesion length is ≤150mm
- •Subject life expectancy >1 year
- •Subject is intended to undergo angiographic and endovascular intervention in the opinion of the investigator(s) and/or per hospital protocols.
- •Subject agrees to undergo treatment with Pulse Peripheral Intravascular Lithotripsy.
排除标准
- •Rutherford Category 0, 1, 5, and
- •Subject has active infection in the target leg requiring antibiotic therapy.
- •Planned major amputation of the target leg (transmetatarsal or higher).
- •In-stent restenosis within the target lesion(s).
- •Significant target vessel tortuosity (bends >30 degrees over the arc length of the balloon) or other parameters prohibiting access to the target lesion.
- •Chronic total occlusion of the target lesion(s) > 40mm.
- •Target lesion(s) within native or synthetic vessel grafts.
- •Chronic total occlusion of inflow vessel.
- •Lesion in contralateral limb requiring intervention within the next 30 days.
- •Subject has had any major (e.g., cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure.
- •Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract (upstream disease) not successfully treated with percutaneous transluminal angioplasty (PTA) or percutaneous stent.
- •Deep heel ulcers or any evidence of osteomyelitis.
- •Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target lesion(s) at the time of the enrollment / index procedure.
- •Subject has a known coagulopathy or has a bleeding diathesis, thrombocytopenia with platelet counts <100,000/microliter, or international normalized ratio >1.
- •Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
- •Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
- •Subject has known allergy to urethane, nylon, or silicone.
- •Myocardial infarction within 60 days prior to enrollment.
- •History of stroke within 60 days prior to enrollment.
- •Subjects that are non-ambulatory and confined to bed.
- •Subject has life expectancy <12 months.
- •History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
- •History of thrombolytic therapy within 2 weeks of enrollment.
- •Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 µmol/L or is on dialysis).
- •Women who are pregnant, breast-feeding, or intend to become pregnant
- •Subject is participating in another investigational drug, biological, or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints of this study, or subject is planning to participate in such studies prior to the completion of this study.
- •Subject has any other condition that, at the discretion of the Investigator, would preclude them completing the study protocol.
结局指标
主要结局
Device Success
时间窗: up to 24 hours
Defined as successful delivery, balloon inflation, deflation, and retrieval of the intact study device without bust below rated burst pressure
Technical Success
时间窗: up to 24 hours
Defined as successful vascular access, completion of endovascular procedure with or without adjunctive therapy, and immediate achievement of less than or equal to 50% residual stenosis of the treated lesion on completion of angiography.
Procedural Success
时间窗: up to 24 hours
Defined as Device Success or Technical Success and absence of procedural complications
Major Adverse Events
时间窗: 30 days
A composite of either unplanned major amputation (above the ankle) or major reintervention of target limb defined as new unplanned surgical bypass graft, the use of thrombectomy or thrombolysis, major surgical graft revision such as a jump graft or an interposition graft, or bail-out stenting at 30 days.
次要结局
- Freedom from target limb revascularization(30 days and 6 months)
- Rutherford Clinical Category(6 months)
- Quality of Life at 30 days and 6 months(30 days and 6 months)
- Ankle-Brachial Index(30 days)
- Walking Capacity(30 days and 6 months)
- VacuQol(30 days and 6 months)
- Major Adverse Event(30 days)
- Clinical Success(up to 24 hours)
- Major Unplanned Amputation(6 months)