NCT05821426尚未招募不适用
Evaluation of the Safety and Effectiveness of Magneto eTrieve™ PE Kit for Endovascular Thrombectomy in Subjects With Acute Pulmonary Embolism
Magneto Thrombectomy Solutions0 个研究点目标入组 130 人开始时间: 2026年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 主要终点
- MAE
研究概览
简要总结
Prospective, multi-center, open-label, single-arm clinical study of the safety and effectiveness of the eTrieve™ in subjects presenting with signs and symptoms of acute intermediate-risk 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Clinical signs, symptoms, and presentation consistent with acute pulmonary embolism (PE)
- •PE symptom duration ≤ 14 days
- •Filling defect in at least one main or lobar pulmonary artery on CTA
- •Right ventricle / left ventricle (RV/LV) ratio ≥ 0.9 on CTA (Investigator's reading)
- •Systolic blood pressure ≥ 90 mmHg
- •Stable heart rate < 130 BPM prior to the index procedure
- •Anatomy that, in the opinion of the interventionalist, allows safe passage of the eTrieve™ catheters
- •Written informed consent
排除标准
- •Patients with a combined reason for their decompensation (e.g., a patient with both sepsis and PE)
- •PE within 3 months prior to screening assessment
- •Thrombolytic use within 30 days prior to baseline CTA
- •Pulmonary hypertension with peak systolic PAP > 70 mmHg
- •Inotrope or vasopressor requirement after fluid administration to keep the systolic blood pressure ≥ 90 mmHg
- •Fraction of inspired Oxygen (FiO2) requirement > 40% or supplemental oxygen > 6 LPM to keep oxygen saturation > 90%
- •Any of the following laboratory findings (within 6 hours prior to index procedure):
- •Hematocrit < 28%
- •Platelets < 100,000/µL
- •Serum creatinine > 1.8 mg/dL
- •Major trauma Injury Severity Score (ISS) > 15 within 14 days prior to screening assessment
- •Intracardiac lead in right ventricle, right atrium or coronary sinus, placed within 6 months prior to screening assessment
- •Known presence of intracardiac clot
- •Cardiovascular or pulmonary surgery within last 7 days
- •Active malignancy and / or on chemotherapy
- •Known bleeding diathesis or coagulation disorder
- •Left bundle branch block
- •History of severe or chronic pulmonary arterial hypertension
- •History of left ventricular ejection fraction ≤ 30%
- •History of decompensated heart failure
- •History of underlying oxygen dependent lung disease
- •History of chest irradiation
- •History of Heparin Induced Thrombocytopenia (HIT)
- •Any contraindication to systemic therapeutic doses of heparin or other anticoagulants
- •Known anaphylactic reaction to radiographic contrast agents that cannot be adequately pre-medicated
- •Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
- •Imaging evidence or other evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention
- •Life expectancy of < 90 days as determined by the investigator
- •Co-morbid condition(s) that, in the opinion of the investigator, 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
- •Female who is pregnant or nursing
- •Current participation in another investigational drug or device treatment study
- •Previous enrollment in the eTrieve™ II Study
研究组 & 干预措施
eTrieve PE Kit
Experimental
干预措施: eTrieve PE Kit (Device)
结局指标
主要结局
MAE
时间窗: 48 hours
Number of Major Adverse Event (MAE) within 48 hours post-index procedure, as adjudicated by the Clinical Events Committee (CEC)
RV/LV ratio
时间窗: 48 hours
Change in RV/LV ratio from baseline to 48 hours post-index procedure (or discharge, whichever occurs first) as assessed by the CTA core laboratory
次要结局
- Mortality(within 30 days)
- Use of thrombolytics(within 48 hours)
- ICU/hospitalization length(within 30 days)
- Device related SAE(within 30 days)
- Modified Miller score(at 48 hours)
- PE reocurrence(within 30 days)
研究者
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