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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
Sponsor: Angiodynamics, Inc.
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.
Official title: Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness (APEX-Return)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
39
Start Date
2026-03
Completion Date
2026-11
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
AlphaReturn Blood Management System
The AlphaReturn Blood Management System allows for autologous injection of aspirated blood from an AlphaVac MMA System thrombectomy procedure.
Locations (3)
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, United States
University at Buffalo
Buffalo, New York, United States
Kettering Health
Kettering, Ohio, United States