NCT04798261招募中不适用
STRIKE-PE: A Prospective, Multicenter Study of the Indigo™ Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 126
- 主要终点
- Performance: Change in RV/LV Ratio
研究概览
简要总结
The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).
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
- •Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
- •RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram
- •Frontline endovascular treatment with the Indigo Aspiration System per IFU
- •Patient is ≥ 18 years of age
- •Informed consent obtained per Institutional Review Board/Ethics Committee requirements
排除标准
- •Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)
- •Stage IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation
- •Known serious, uncontrolled sensitivity to radiographic agents
- •Life expectancy < 180 days
- •Patients on ECMO
- •Pregnant patients
- •Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies
- •Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
研究组 & 干预措施
Patients with acute pulmonary embolism
干预措施: Indigo Aspiration System (Device)
结局指标
主要结局
Performance: Change in RV/LV Ratio
时间窗: 48 hours post-procedure
Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available)
Safety: Composite of major adverse events
时间窗: 48 hours
A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury
次要结局
- Any-cause mortality(Within 30 days)
- Symptomatic PE recurrence(Within 30 days)
- Functional outcome assessed NYHA(90 days post-procedure)
- Functional outcome assessed via 6MWT(90 days post-procedure)
- Quality of Life assessed via PEmb-QoL(90 days post-procedure)
- Quality of Life assessed via EQ-5D-5L(90 days post-procedure)
- Perceived dyspnea assessed via Borg Scale(90 days post-procedure)
- Incidence of device related SAE(s)(365 days)
研究者
研究点 (126)
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