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

May 7, 2026 updated by: Angiodynamics, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicenter, single-arm investigational device study evaluating safety and effectiveness.

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Saint Cloud, Minnesota, United States, 56303
        • Recruiting
        • CentraCare Heart and Vascular Center
        • Principal Investigator:
          • Brian Stegman, MD
        • Contact:
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo
        • Principal Investigator:
          • David Zlotnick, MD
        • Contact:
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Jacobi Medical Center
        • Principal Investigator:
          • Seth Sokol, MD
        • Contact:
    • Ohio
      • Kettering, Ohio, United States, 45429
        • Recruiting
        • Kettering Health
        • Principal Investigator:
          • Ammar Safar, MD
        • Contact:
    • Texas
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Heart Hospital Plano
        • Principal Investigator:
          • Sameh Sayfo, MD
        • Contact:
      • San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: AlphaReturn Blood Management System
The AlphaReturn Blood Management System allows for autologous injection of aspirated blood from an AlphaVac MMA System thrombectomy procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Device-Related Adverse Events (AEs)
Time Frame: Through 30 days post-procedure
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
Time Frame: Periprocedural
Successful autologous blood transfusion using the AlphaReturn Blood Management System
Periprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Major Adverse Events (MAEs)
Time Frame: Through 48 hours post-procedure
The rate of MAEs within the first 48 hours after the index procedure. MAEs include device-related death, major bleeding, and device-related SAEs of clinical deterioration, pulmonary vascular injury, and cardiac injury.
Through 48 hours post-procedure
Rate of Complications
Time Frame: Through 48 hours post-procedure
Rate of complications including device-related clinical deterioration, device-related cardiac injury, device-related pulmonary vascular injury, major bleeding, and device-related death within 48 hours of the index procedure.
Through 48 hours post-procedure
Rate of Device-Related SAEs
Time Frame: Through 30 days post-procedure
Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post procedure.
Through 30 days post-procedure
Rate of Symptomatic PE recurrence within 30 days
Time Frame: Through 30 days post-procedure
Symptomatic PE recurrence within 30 days.
Through 30 days post-procedure
Reduction in RV/LV Ratio
Time Frame: Through 48 hours post-procedure
Reduction in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.
Through 48 hours post-procedure
Thrombolytics Use
Time Frame: Through 48 hours post-procedure
Use of thrombolytics during or within 48 hours of the procedure.
Through 48 hours post-procedure
Length of Stay in Intensive Care Unit
Time Frame: Through 30 days post-procedure
Length of stay in the Intensive Care Unit (ICU) within 30 days post-procedure.
Through 30 days post-procedure
Length of Stay in Hospital
Time Frame: Through 30 days post-procedure
Length of stay in the hospital within 30 days post-procedure.
Through 30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angiodynamics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-CAR-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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