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

NCT07280247 | Recruiting FDA Device

• 1 other identifier: 2025-CAR-03
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Pulmonary Embolism Acute

Keywords

pulmonary embolism; alphareturn

Outcome Measures

Primary Outcomes (2)

• Rate of Device-Related Adverse Events (AEs)

  The number and proportion of subjects who experienced at least one device-related adverse event. This will be summarized, and the 95% confidence interval of the proportion will be presented. The incidence of device-related adverse events by type and seriousness through 30 days will also be summarized.

  Through 30 days post-procedure

• Rate of Technical Success

  Successful autologous blood transfusion using the AlphaReturn Blood Management System

  Periprocedural

Secondary Outcomes (8)

• Rate of Major Adverse Events (MAEs)

  Through 48 hours post-procedure

• Rate of Complications

  Through 48 hours post-procedure

• Rate of Device-Related SAEs

  Through 30 days post-procedure

• Rate of Symptomatic PE recurrence within 30 days

  Through 30 days post-procedure

• Reduction in RV/LV Ratio

  Through 48 hours post-procedure

Study Arms (1)

AlphaVac MMA F1885 System and AlphaReturn Blood Management System

EXPERIMENTAL

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.

Device: AlphaReturn Blood Management System

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.

AlphaVac MMA F1885 System and AlphaReturn Blood Management System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects who have FiO2 requirement \> 44% or \> 6 LPM to keep oxygen saturations \> 90%.
• Subjects with hematocrit \< 28% within 6 hours of index procedure.
• Subjects with platelets count \< 100,000/μL.
• Subjects with serum creatinine \> 1.8 mg/dL.
• Subjects with International Normalized Ratio (INR) \> 3.
• Subjects who have undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) \> 15.
• Subjects with the presence of cancer requiring active chemotherapy.
• Subjects with known bleeding diathesis or coagulation disorder.
• Subjects who have had a cardiovascular or pulmonary surgery within the past 7 days of index procedure.
• 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%.
• Subjects with known anaphylactic reaction to radiographic contrast agents that cannot be pretreated.

Sponsors & Collaborators

• Angiodynamics, Inc.: lead

Study Sites (4)

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States

RECRUITING

University at Buffalo

Buffalo, New York, 14203, United States

RECRUITING

Jacobi Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Kettering Health

Kettering, Ohio, 45429, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Elizabeth Manning

CONTACT

339-237-2765; liz.manning@angiodynamics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 12, 2025
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (4)