NCT05318092已完成不适用
Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 50
- 主要终点
- Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA)
研究概览
简要总结
To evaluate the safety and effectiveness of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in a prospective trial of patients with acute intermediate-risk 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
- •Signed and dated informed consent form.
- •18 years of age and older.
- •Clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days.
- •Diagnosis of pulmonary embolism detected from computed tomography angiography (CTA).
- •Right Ventricle to Left Ventricle (RV/LV) ratio of 0.9 or higher.
- •Systolic blood pressure (SBP) of 90 mmHg or higher
- •Heart rate of 130 beats per minute (BPM) or less prior to the procedure.
- •Deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment.
排除标准
- •Excluded from the study if he/she meets any of the following exclusion criteria
- •May be pregnant as determined by a positive pregnancy test or who are breastfeeding.
- •Has any contraindication to systemic or therapeutic doses of heparin or anticoagulants.
- •Has used thrombolytics (tPA) in the past 30 days of baseline CTA.
- •Has pulmonary hypertension with peak pulmonary artery pressure (PAP) > 70 mmHg.
- •Fraction of inspired oxygen (FiO2) requirement >40% or >6 liters per minute (LPM) to keep oxygen saturations >90%
- •Hematocrit <28% within 6 hours of the index procedure.
- •Platelets count < 100,000/µL.
- •Serum creatinine >1.8 mg/dL.
- •International Normalized Ratio (INR) > 3
- •Has undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) >
- •Presence of cancer requiring active chemotherapy.
- •Known bleeding diathesis or coagulation disorder.
- •Has had a cardiovascular or pulmonary surgery within the past 7 days of index procedure.
- •History of severe or chronic pulmonary hypertension, uncompensated heart failure, chest irradiation, underlying lung disease that is oxygen dependent, Heparin-induced thrombocytopenia (HIT) and/or chronic left heart disease with left ventricular ejection fraction ≤ 30%.
- •Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated.
- •Requires Vasopressor after fluids to keep pressure ≥ 90 mmHg.
- •With left bundle branch block.
- •Has intracardiac lead in the right ventricle or atrium.
- •Evidence such as imaging or other that suggests the subject is not appropriate for this procedure.
- •Has life expectancy < 90 days.
- •Dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO).
- •Participation in another investigational study
结局指标
主要结局
Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA)
时间窗: At 48 hours post-procedure
Change in Right Ventricle to Left Ventricle (RV/LV) ratio between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the study's core lab.
Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure.
时间窗: Within 48 hours post-procedure
Rate of Major Adverse Events (MAEs) within the first 48 hours after the index procedure, defined as: Device-related death Major bleeding Device-related SAEs of: * Clinical Deterioration * Pulmonary Vascular Injury * Cardiac Injury
次要结局
- Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA).(At 48 hours post-procedure)
- Use of Thrombolytics Within 48 Hours of the Procedure.(Within 48 hours of the procedure)
- Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days.(Within 30 days of the procedure)
- Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure.(Within 48 hours of the procedure)
- Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure.(Within 30 days of the procedure)
- Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure.(Within 30 days of the procedure)
研究者
研究点 (50)
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