Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System an… (NCT07280247) | Clinical Trial Compass
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Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness
United States39 participantsStarted 2026-03-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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.
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.