NCT06062329已完成不适用
Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism
Imperative Care, Inc.19 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年12月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 19
- 主要终点
- Rate of Major Adverse Events
研究概览
简要总结
Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism
详细描述
SYMPHONY-PE is a pivotal study intended to assess the safety and efficacy of the Symphony Thrombectomy System to treat subjects with acute pulmonary embolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CTA evidence of acute PE within ≤14 days
- •Clinical signs and symptoms consistent with acute PE.
- •Systolic BP ≥90 mmHg with evidence of dilated RV with an RV/LV ratio >0.9 (based on Investigator's assessment of RV/LV ratio)
- •Stable heart rate <130 BPM prior to procedure
- •Subject is between 18 and 80 years of age
- •Subject is willing to sign an IRB-approved informed consent form
- •Subject is willing and able to comply with protocol follow-up
排除标准
- •Thrombolytic use within 14 days of baseline CTA
- •International Normalized Ratio (INR) >3
- •Platelets <100,000/µL
- •Kidney dysfunction as confirmed by serum creatinine >1.8 mg/dL or GFR <45 mL/min
- •Hematocrit <28% or hemoglobin <9 g/dL
- •Systolic BP <90 mmHg for 15 min or requirement of inotropic support to maintain systolic BP ≥90 mmHg any time after admission
- •Experienced cardiac arrest
- •Has left bundle branch block
- •Known bleeding diathesis or coagulation disorder
- •Presence of intracardiac lead in the right ventricle or right atrium
- •Presence of intracardiac thrombus
- •Major trauma within the past 14 days
- •Cardiovascular or pulmonary surgery within last 7 days
- •Known serious, uncontrolled sensitivity to radiographic agents
- •Contraindication to anticoagulants, i.e., heparin or alternative
- •Patient on extracorporeal membrane oxygenation (ECMO)
- •Cancer requiring active chemotherapy
- •Heparin-induced thrombocytopenia (HIT)
- •Pulmonary hypertension with peak pulmonary artery pressure >70 mmHg by right heart catheterization.
- •History of chronic severe pulmonary hypertension, and/or chronic left heart disease with left ventricular ejection fraction ≤30%
- •Life expectancy <90 days as determined by investigator
- •Pregnant or nursing
- •COVID-19 positive at hospital admission
- •Current participation in another investigational study
- •Evidence such as imaging or other that suggests the subject is not appropriate for this procedure (e.g., target vessel size is too small to accommodate 16F or 24F catheters).
研究组 & 干预措施
Symphony Thrombectomy system
Experimental
Mechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism.
干预措施: Symphony Thrombectomy System (Device)
结局指标
主要结局
Rate of Major Adverse Events
时间窗: 48 hours
A composite of all-cause major bleeding, device-related mortality, device-related serious adverse events
Mean Reduction of RV/LV Ratio
时间窗: Baseline to 48 hours
Change in RV/LV ratio from baseline to 48 hours post procedure assessed by CT Angiography (CTA) and adjudicated by an independent core-lab
次要结局
- Secondary Safety Endpoints: 48 Hours(48 Hours)
- Secondary Safety Endpoints: 30 Days(30 Days)
研究者
研究点 (19)
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