NCT07280247招募中不适用
Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness (APEX-Return)
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 6
- 主要终点
- Rate of Technical Success
研究概览
简要总结
The investigation is intended to evaluate the safety and effectiveness of the AlphaReturn Blood Management System when used in conjunction with the cleared AlphaVac MMA F1885 System for the treatment of acute pulmonary embolism.
详细描述
This is a prospective, multicenter, single-arm investigational device study evaluating safety and effectiveness.
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
- •A potential subject will be included in the study if he/she meets all the following inclusion criteria:
- •Provision of signed and dated informed consent form.
- •Subject is 18 years of age and older.
- •Subject presents clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days.
- •Subject has a diagnosis of pulmonary embolism detected from computed tomography angiography (CTA).
- •Subject has a RV/LV ratio of 0.9 or higher.
- •Subject has a systolic blood pressure (SBP) of 90mmHg or higher.
- •Subject has a heart rate of 130 beats per minute (BPM) or less prior to the procedure.
- •Subject is deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment.
排除标准
- •A potential subject will be excluded from the study if he/she meets any of the following exclusion criteria:
- •Subjects who are or may be pregnant as determined by a positive pregnancy test or who are breastfeeding.
- •Subjects who have any contraindication to systemic or therapeutic doses of heparin or anticoagulants.
- •Subjects who have used thrombolytics in the 30 days prior to the baseline CTA.
- •Subjects who have pulmonary hypertension with peak pulmonary artery pressure (PAP) > 70 mmHg.
- •Subjects who have FiO2 requirement > 44% or > 6 LPM to keep oxygen saturations > 90%.
- •Subjects with hematocrit < 28% within 6 hours of index procedure.
- •Subjects with platelets count < 100,000/μL.
- •Subjects with serum creatinine > 1.8 mg/dL.
- •Subjects with International Normalized Ratio (INR) >
- •Subjects who have undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) >
- •Subjects with the presence of cancer requiring active chemotherapy.
- •Subjects with known bleeding diathesis or coagulation disorder.
- •Subjects who have had a cardiovascular or pulmonary surgery within the past 7 days of index procedure.
- •Subjects with a 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%.
- •Subjects with known anaphylactic reaction to radiographic contrast agents that cannot be pretreated.
- •Subject requires vasopressor after fluids to keep pressure ≥ 90mmHg.
- •Subjects with left bundle branch block.
- •Subjects who have intracardiac lead in the right ventricle or atrium.
- •Evidence such as imaging or other that suggest the subject is not appropriate for this procedure.
- •Subjects that have life expectancy < 90 days, in the opinion of the investigator at the time of enrollment.
- •Subjects dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO).
- •Participation in another investigational study.
研究组 & 干预措施
AlphaVac MMA F1885 System and AlphaReturn Blood Management System
Experimental
Following mechanical thrombectomy using the AlphaVac MMA System, the treating physician will filter the aspirated blood using the AlphaReturn Blood Management System and reinfuse the filtered autologous blood back into the patient.
干预措施: AlphaReturn Blood Management System (Device)
结局指标
主要结局
Rate of Technical Success
时间窗: Periprocedural
Successful autologous blood transfusion using the AlphaReturn Blood Management System
Rate of Device-Related Adverse Events (AEs)
时间窗: Through 30 days post-procedure
The number and proportion of subjects who experienced at least one device-related adverse event. This will be summarized, and the 95% confidence interval of the proportion will be presented. The incidence of device-related adverse events by type and seriousness through 30 days will also be summarized.
次要结局
- Length of Stay in Intensive Care Unit(Through 30 days post-procedure)
- Length of Stay in Hospital(Through 30 days post-procedure)
- Rate of Major Adverse Events (MAEs)(Through 48 hours post-procedure)
- Rate of Complications(Through 48 hours post-procedure)
- Rate of Device-Related SAEs(Through 30 days post-procedure)
- Rate of Symptomatic PE recurrence within 30 days(Through 30 days post-procedure)
- Reduction in RV/LV Ratio(Through 48 hours post-procedure)
- Thrombolytics Use(Through 48 hours post-procedure)
研究者
研究点 (6)
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