RecruitingNot ApplicableNCT07280247

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

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


Sponsor

Angiodynamics, Inc.

Enrollment

39 participants

Start Date

Mar 30, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called AlphaReturn Blood Management System for people with pulmonary embolism acute. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAlphaReturn Blood Management System

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


Locations(6)

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, United States

University at Buffalo

Buffalo, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

Kettering Health

Kettering, Ohio, United States

Baylor Heart Hospital Plano

Plano, Texas, United States

Methodist Healthcare

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07280247


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