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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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