Prospective Multi-Center, Post-Market, Observational Study (OS) of the Shockwave Medical, Inc. Intravascular Lithotripsy System in Peripheral Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,373
- 试验地点
- 30
- 主要终点
- Procedural Success - Primary Effectiveness Endpoint
研究概览
简要总结
The Disrupt PAD III study was designed as a randomized controlled trial (RCT) with an additional observational registry component. The registry, referred to as the Disrupt PAD III Observational Study (PAD III OS), was a global, prospective, multi-center, single-arm registry of the Shockwave Peripheral Intravascular Lithotripsy (IVL) System. The objective of this study was to assess the real-world acute performance of IVL in the treatment of calcified, stenotic, peripheral arteries that may not qualify for inclusion in the RCT. The study was designed to enroll a maximum of 1500 subjects from up to 60 global sites with a minimum of 200 subjects treated with the S4 IVL catheter, a line extension designed to treat smaller diameter peripheral vessels, including calcified below-the-knee (BTK) lesions.
Subjects were required to have target lesions in the iliac, femoral, ilio-femoral, popliteal, or infra-popliteal arteries with at least moderate calcification as determined by the investigator, defined as calcification within the lesion on both sides of the vessel assessed by angiography. Adjunctive therapies such as atherectomy, specialty balloons, and stents were allowed. Subjects were followed through discharge.
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
- •Subjects were required to meet ALL of the following inclusion criteria in order to be included in this clinical study:
- •Subjects intended to be treated with Shockwave Medical Lithoplasty for de-novo or restenotic lesions of the femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
- •Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limb.
- •Age of subject is >
- •Subject of subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
- •Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.
排除标准
- •Subjects that met ANY of the following exclusion criteria were not included in this clinical study:
- •Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Lithoplasty as per Instructions for Use (IFU) or investigator's opinion.
- •Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
结局指标
主要结局
Procedural Success - Primary Effectiveness Endpoint
时间窗: Peri-procedural, approximately 2 hours
Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ grade D) by angiographic core lab. In the primary analysis, Procedural Success was assessed on a per-subject basis; for subjects with multiple IVL-treated lesions, Procedural Success was achieved if all lesions met criteria.
次要结局
- Procedural Success - Secondary Effectiveness Endpoint(Peri-procedural, approximately 2 hours)