A Multicenter, International, Retrospective Observational Study Evaluating the Safety and Effectiveness of the AngioVac System Across Clinical Indications
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Safety and technical effectiveness of AngioVac
研究概览
简要总结
As a structured, multinational retrospective registry the AVATAR Registry addresses the following scientific aspects through systematic data collection, centralized quality control, and robust statistical analysis in patients that were treated with the AngioVac Aspiration System:
- Quantify Real-World Safety: Composite adverse event rates across diverse populations and indications
- Assess Effectiveness: Technical and clinical success rates stratified by indication
- Identify Predictors: Clinical, procedural, and anatomical factors predicting success versus complications
- Generate Publishable Cohorts: Sufficient statistical power (approx. 1000 patients across 8 indication cohorts) for:
- Indication-specific outcomes
- Multivariable prediction models
- Time-to-event analyses (30-day and 12-month mortality)
- Establish Best Practices: Evidence-based recommendations for patient selection, procedural technique, and follow-up
详细描述
The AngioVac Aspiration System is a percutaneous device that enables removal of intravascular and intracardiac thrombotic or infectious material using a venovenous extracorporeal circuit with blood filtration and reinfusion. The system combines:
- Direct aspiration of thrombi or vegetations
- In-line blood filtration (protecting distal circulation)
- Lower embolic risk compared to surgical extraction
The AngioVac applications include the following clinical situations:
- CIED-Related Pathology: Lead-associated thrombus and vegetations during cardiac implantable electronic device (CIED) extraction
- Infective Endocarditis: Right-sided infective endocarditis with large vegetations
- Venous Thrombosis: Central venous thrombi (SVC, IVC, iliofemoral) and right atrial/ventricular thrombi
- Pulmonary Artery: Acute pulmonary artery thrombotic material
- Malignancy-Associated: Cancer-associated thrombosis and catheter-associated thrombi
Despite increasing clinical adoption, the evidence base remains limited:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age ≥18 years at time of AngioVac procedure
- •Patient underwent percutaneous AngioVac aspiration (any AngioVac model or version used clinically during study period)
- •Procedure performed within study period (January 2018 (or site's institutional start date) - June 2026)
- •Written informed consent OR documented waiver/exemption from ethics authority (per local regulations per GDPR)
排除标准
- •Insufficient documentation to assess primary safety or effectiveness endpoints (e.g. defined as >20% missing data in core endpoint variables)
- •Patient objection to retrospective data use (where required by local law; GDPR Article 21 opt-out; honored without study impact)
- •Non-AngioVac procedures: Patients undergoing thrombus/vegetation removal by surgery or other percutaneous devices only (not AngioVac)
结局指标
主要结局
Safety and technical effectiveness of AngioVac
时间窗: From intervention to the end of 12month
Evaluation of in-hospital safety and procedural effectiveness of AngioVac in real-world practice across indications.
次要结局
- Various secondary endpoints(From intervention to the end of 12month)
研究者
Christoph Starck
Senior Consultant
Charite University, Berlin, Germany