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

Part of paid clinical trials in Saint Cloud, Minnesota.

Sponsor
Angiodynamics, Inc.
Study ID
NCT07280247
Status
Recruiting
Apply to this trial

Conditions

  • Pulmonary Embolism Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AlphaVac MMA F1885 System and AlphaReturn Blood Management System
    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.

Primary Outcome Measure

Rate of Device-Related Adverse Events (AEs) [ Time Frame: Through 30 days post-procedure ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
CentraCare Heart and Vascular CenterSaint CloudMinnesota56303
Kelly Kobylinski
[email protected]
320-251-2700
Brian Stegman, MD (PRINCIPAL_INVESTIGATOR)
University at BuffaloBuffaloNew York14203
Monica Nowak
[email protected]
716-888-4712
David Zlotnick, MD (PRINCIPAL_INVESTIGATOR)
Jacobi Medical CenterThe BronxNew York10461
Cidney Schultz
[email protected]
718-918-6212
Seth Sokol, MD (PRINCIPAL_INVESTIGATOR)
Kettering HealthKetteringOhio45429
Chris Seger
[email protected]
937-395-8365
Ammar Safar, MD (PRINCIPAL_INVESTIGATOR)
Baylor Heart Hospital PlanoPlanoTexas75093
Christopher Quiocho
[email protected]
469-814-4735
Sameh Sayfo, MD (PRINCIPAL_INVESTIGATOR)
Methodist HealthcareSan AntonioTexas78229
Susana Mondaca
[email protected]
210-575-9766
Chandra Kunavarapu, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Saint Cloud, MN

By research site
CentraCare Heart and Vascular Center· Saint Cloud, MNUniversity at Buffalo· Buffalo, NYJacobi Medical Center· The Bronx, NYKettering Health· Kettering, OHBaylor Heart Hospital Plano· Plano, TXMethodist Healthcare· San Antonio, TX

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