PEARL II: PEripheral Use of AngioJet® Rheolytic Thrombectomy With a Variety of Catheter Lengths
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 35
- 主要终点
- Rethrombosis
研究概览
简要总结
The Registry involves the collection of information for research and educational purposes only on the use of AngioJet in the peripheral vascular system.
详细描述
The PEARL II Registry is a prospective, multi-center, observational registry including 500 patients who meet eligibility from up to 50 sites worldwide. Patient participation will be 12 months including post procedure follow-up contact at 3, 6 and 12 months. The study duration is estimated at 36 months.
A patient's treatment is determined by the treating physician based on the clinical situation and local practices. In contrast to a randomized, controlled trial, there are no pre-defined experimental interventions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been treated in the peripheral vascular system with any of the AngioJet System catheters.
- •Patient has provided appropriate consent/authorization per the site's institutional policy and procedure.
排除标准
- •Patient has previously been enrolled in either the PEARL Registry or the PEARL II Registry in the last 12months.
结局指标
主要结局
Rethrombosis
时间窗: 3 Month , 6 Month and 12 Month Follow Up
The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.
Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.
时间窗: Day 1
From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms/venograms, each vessel was assigned a value by the treating physician. 1. complete occlusion (\>90% occlusion); 2. substantial occlusion (50-90% occlusion OR \<50% occlusion and \>3cm in length); 3. partial occlusion (\<50% occlusion AND \<3cm in length) 4. patent (without visable thrombus or occlusion) The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic/venographic value from the final value.
次要结局
- Concomitant Treatments Used With the AngioJet® System(Day 1)