Safety and Feasibility of the Shockwave Lithoplasty® System for the Treatment of Peripheral Vascular Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Composite of new-onset Major Adverse Events (MAE)
研究概览
简要总结
To observe early safety and performance of the Shockwave Medical Lithoplasty® System (specifically, Lithoplasty® Catheters: 2.5 x 60mm, 2.75 x 60mm, 3.0 x 60mm, 3.25 x 60mm, and 3.5 x 60mm) in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized pulsatile mechanical energy for balloon dilation of calcified, stenotic, infrapopliteal arteries.
详细描述
Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the early safety and performance of the Shockwave Lithoplasty® System in subjects with moderate to heavily calcified peripheral arteries with 2.5mm to 3.5mm reference vessel diameter at the target site. The Shockwave Lithoplasty® System is indicated for lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to twenty subjects will be enrolled and treated with Lithoplasty® System.
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 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.
- •Age of subject is >
- •Rutherford Clinical Category 1 -
- •Angiographic Inclusion Criteria:
- •Single or multiple target lesion(s) is/are located in a de novo artery distal to the trifurcation vessels and extends to and ends above the ankle
- •Target vessel reference diameter is between 2.5mm and 3.5mm by visual estimate
- •Target lesion with diameter stenosis ≥50% by investigator via visual estimate
- •If inflow disease >50% proximal to the trifurcation vessels is present, and it can be treated with POBA, stent or Lithoplasty and without complications.
- •Target lesion is ≤150mm in length
- •Subject has at least one patent tibial vessel (>50%) with run-off to the foot.
- •No evidence of aneurysm or acute thrombus in target vessel.
- •Any presence of calcification within the target lesion as assessed by imaging (radiograph, CT or angiography).
排除标准
- •Rutherford Clinical Category
- •Target lesion is within only lower extremity vessel with < 50% stenosis.
- •Gangrene of the lower extremity.
- •Planned major amputation of the target leg.
- •Previously implanted stent in the treatment lesion
- •Target lesion length exceeds 150mm.
- •Patient has chronic total occlusion of target lesion.
- •Patient has significant stenosis (>50% stenosis) or occlusion of inflow tract (e.g., iliac or common femoral) not successfully treated with POBA, stent or Lithoplasty and without complications.
- •Patient in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
- •Patient has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
- •Patient has known allergy to urethane, nylon, or silicone.
- •Patient is pregnant or nursing.
- •Patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
研究组 & 干预措施
Lithoplasty Treatment
Patients in this group will receive treatment with the Shockwave Lithoplasty® System which uses lithotripsy-enhanced, low-pressure balloon dilation of calcified stenotic peripheral arteries.
干预措施: Shockwave Lithoplasty® System (Device)
结局指标
主要结局
Composite of new-onset Major Adverse Events (MAE)
时间窗: Procedure through 30 days post procedure
Death Myocardial infarction Need for emergency surgical revascularization of the target limb. Amputation of target limb.
Efficacy
时间窗: Peri-Procedural
Acute reduction in percent (%) diameter stenosis of target lesion
次要结局
- Procedural Success(Peri-Procedural)