NCT06189313暂停不适用
A Prospective, Multicenter Study to Evaluate the Safety and Efficacy of an Aspiration Thrombectomy System in Acute Pulmonary Embolism
Argon Medical Devices20 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2025年1月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 125
- 试验地点
- 20
- 主要终点
- Change in Right Ventricle (RV)/Left Ventricle (LV) Ratio
研究概览
简要总结
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age at the time of consent
- •Clinical signs, symptoms, and presentation consistent with acute PE
- •Onset of PE symptoms occurred within 14 days of presentation
- •Filling defect in at least one main or lobar pulmonary artery evidenced by CTA
- •RV dysfunction on CTA or echocardiography defined as RV/LV ratio >0.9
排除标准
- •tPA use within 14 days prior to baseline CTA
- •Systolic BP <90 mmHg for 15 min or the requirement of inotropic support to maintain systolic BP ≥90 mmHg
- •Diagnosis of pulmonary hypertension primary type I or CTEPH; if patient does not have diagnosis of pulmonary hypertension but peak PA >70 mmHg by right heart catheterization or elevated main pulmonary artery to aorta ratio (MPA:A), up to investigator discretion.
- •History of severe or chronic pulmonary hypertension
- •FiO2 requirement >40% or >6 LPM to keep oxygen saturations >90%
- •Hematocrit <28%
- •Platelets <100,000/µL
- •Serum creatinine >1.8 mg/dL
- •aPTT (or PTT) >50 seconds on no anticoagulation
- •History of heparin-induced thrombocytopenia (HIT)
- •Recent (within six months) history of stroke, transient ischemic attack (TIA), or intracranial bleeding
- •Recent (within one month) history of active bleeding from a major organ
- •Absolute contraindication to anticoagulation
- •Major trauma such as head trauma, or other active intracranial, or intraspinal disease within 14 days
- •Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
- •Cardiovascular or pulmonary surgery within last 7 days
- •Cancer which requires active chemotherapy
- •Known serious, uncontrolled sensitivity to radiographic agents
- •Life expectancy <90 days, as determined by investigator
- •Female who is pregnant
- •Intracardiac thrombus
- •Patients who present with cardiac arrest and/or are on extracorporeal membrane oxygenation (ECMO) or ECMO required to perform interventional procedure
- •Simultaneous participation in another investigational study
- •Patients with known coagulation disorders such as antiphospholipid, Protein C, and Protein S
- •Presentation of PE with paradoxical emboli which may be diagnosed by concurrent stroke or concurrent arterialization
研究组 & 干预措施
Mechanical Thrombectomy via Cleaner Pro
Experimental
Participants will receive catheter-directed therapy via mechanical aspiration thrombectomy for the treatment of pulmonary embolism (PE) using the Cleaner Pro Thrombectomy System.
干预措施: Cleaner Pro Thrombectomy System (Device)
结局指标
主要结局
Change in Right Ventricle (RV)/Left Ventricle (LV) Ratio
时间窗: At 48 hours post-procedure
Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.
Rate of Major Adverse Events (MAEs)
时间窗: At 48 hours post-procedure
Rate of MAEs within the first 48 hours after the index procedure, defined as: Device-related death Major bleeding, and Device-related Serious Adverse Events which includes clinical deterioration, pulmonary vascular injury, and cardiac injury.
次要结局
- Volume of blood aspirated(At index procedure)
- Rate of device-related SAEs and all-cause mortality(Within 30 days of procedure)
- Use of thrombolytics(Within 48 hours of the procedure)
- Rate of device-related complications and device-related death(Within 48 hours of the procedure)
- Rate of Symptomatic PE Recurrence(Within 30 days of the procedure)
- Quality of Life assessed via PEmb-QoL(At 30 days post-procedure)
- Quality of Life assessed via EQ-5D-5L(At 30 days post-procedure)
- Change in Modified Miller Index(At 48 hours post-procedure)
研究者
研究点 (20)
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