International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Efficacy: Technical success - defined as intention-to-treat basis
研究概览
简要总结
Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.
The aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F/BEVAR.
详细描述
Standardized forms will collect data on the performed procedure, underlying pathology, cardiovascular risks and information on preoperative examinations. Physiological parameters routinely measured prior, during and after any surgical intervention will be recorded as well. A 1 month, 6-months and 12-months follow-up visit will be conducted to assess adverse events and outcome of the index procedure.
In addition, this study aims to analyze the technical and procedure success to gain access via hostile iliac access vessels withShockwave Peripheral Intravascular Lithotripsy Balloon in patients submitted for complex endovascualre thoracic, throaco-abdominal or abdominal aortic repair.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patient (m/f) age ≥ 18 years at time of enrollment.
- •Diagnosis of thoracic and/or thoraco-abdominal (Extent I-V) and juxta/para-renal/short-neck aneurysm requiring the implantation of a thoracic and/or thoraco-abdominal fenestrated/branched aortic endograft with delivery system introducer sheath diameter equal or larger than 18 Fr (6 mm).
- •Hostile iliac access was defined in the presence of:
- •Heavily circumferential calcified iliac arteries
- •Inner diameter ≤ 6 mm
- •Severe stenosis (> 50%; > 2.5 m/s peak velocity; absence of triphasic duplex signal in ipsilateral common femoral artery)
- •We will accept the following presentations of aneurysm:
- •urgent cases,
- •elective,
- •symptomatic
- •and fast growing.
- •The repair was performed using Shockwave™ before the introduction of the main endograft. The iliac procedures can be accompanied by angioplasty and/or stent and stent-graft positioning.
排除标准
- •Patients submitted to surgical conduit bypass.
- •Not-severely calcified disease (absence of calcification).
- •In-stent restenosis/occlusion.
- •Inability to cross with 0.014 guidewire.
- •Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study.
- •Pre-stented iliac access vessels at the level of Shockwave implementation.
结局指标
主要结局
Efficacy: Technical success - defined as intention-to-treat basis
时间窗: 30 days
* Successful dilatation of the access vessels to 8mm without rupture * Successful endovascular access and deployment of all aortic devices * Performance of the Shockwave™ IVL: Includes the definition for technical success as well as delivery of the intended main endograft without the need for surgical conversion, arterial rupture and iliac artery occlusion
次要结局
未报告次要终点