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Clinical Trials in the USA / NCT07280247
Recruiting Not applicable

Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness

NCT07280247 · tracked via the Priya Life Science USA tracker
Sponsor
Angiodynamics, Inc.
Phase
Not applicable
Started
2026-03-30
Last updated
2026-05-11

Condition(s) studied

Pulmonary Embolism Acute

Investigational drug(s) / intervention(s)

AlphaReturn Blood Management System

AlphaReturn Blood Management System: The AlphaReturn Blood Management System allows for autologous injection of aspirated blood from an AlphaVac MMA System thrombectomy procedure.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: A potential subject will be included in the study if he/she meets all the following inclusion criteria: 1. Provision of signed and dated informed consent form. 2. Subject is 18 years of age and older. 3. Subject presents clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days. 4. Subject has a diagnosis of pulmonary embolism detected from computed tomography angiography (CTA). 5. Subject has a RV/LV ratio of 0.9 or higher. 6. Subject has a systolic blood pressure (SBP) of 90mmHg or higher. 7. Subject has a heart rate of 130 beats per minute (BPM) or less prior to the procedure. 8. Subject is deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment. Exclusion Criteria: A potential subject will be excluded from the study if he/she meets any of the following exclusion criteria: 1. Subjects who are or may be pregnant as determined by a positive pregnancy test or who are breastfeeding. 2. Subjects who have any contraindication to systemic or therapeutic doses of heparin or anticoagulants. 3. Subjects who have used thrombolytics in the 30 days prior to the baseline CTA. 4. Subjects who have pulmonary hypertension with peak pulmonary artery pressure (PAP) \> 70 mmHg. 5. Subjects who have FiO2 requirement \> 44% or \> 6 LPM to keep oxygen saturations \> 90%. 6. Subjects with hematocrit \< 28% within 6 hours of index procedure. 7. Subjects with platelets count \< 100,000/μL. 8. Subjects with serum creatinine \> 1.8 mg/dL. 9. Subjects with International Normalized Ratio (INR) \> 3. 10. Subjects who have undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) \> 15. 11. Subjects with the presence of cancer requiring active chemotherapy. 12. Subjects with known bleeding diathesis or coagulation disorder. 13. Subjects who have had a cardiovascular or pulmonary surgery within the past 7 days of index procedure. 14. 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%. 15. Subjects with known anaphylactic reaction to radiographic contrast agents that cannot be pretreated. 16. Subject requires vasopressor after fluids to keep pressure ≥ 90mmHg. 17. Subjects with left bundle branch block. 18. Subjects who have intracardiac lead in the right ventricle or atrium. 19. Evidence such as imaging or other that suggest the subject is not appropriate for this procedure. 20. Subjects that have life expectancy \< 90 days, in the opinion of the investigator at the time of enrollment. 21. Subjects dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO). 22. Participation in another investigational study.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
CentraCare Heart and Vascular Center Saint Cloud Minnesota Recruiting
University at Buffalo Buffalo New York Recruiting
Jacobi Medical Center The Bronx New York Recruiting
Kettering Health Kettering Ohio Recruiting
Baylor Heart Hospital Plano Plano Texas Recruiting
Methodist Healthcare San Antonio Texas Recruiting

More Angiodynamics, Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07280247 on ClinicalTrials.gov ↗ ← All trials in the USA