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Pulmonary Embolism AcuteAPEX-ReturnNCT07280247

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

A study testing AlphaReturn Blood Management System in people with Pulmonary Embolism Acute, run by Angiodynamics, Inc. at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism Acute
What is being tested?
AlphaReturn Blood Management System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
6 sitesUnited States
Study dates
30 Mar 2026to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A potential subject will be included in the study if he/she meets all the following inclusion criteria:
  • 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.
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  • 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.

Who cannot join

  • A potential subject will be excluded from the study if he/she meets any of the following exclusion criteria:
  • 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%.
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  • 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.
  • Subject requires vasopressor after fluids to keep pressure ≥ 90mmHg.
  • Subjects with left bundle branch block.
  • Subjects who have intracardiac lead in the right ventricle or atrium.
  • Evidence such as imaging or other that suggest the subject is not appropriate for this procedure.
  • Subjects that have life expectancy < 90 days, in the opinion of the investigator at the time of enrollment.
  • Subjects dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO).
  • Participation in another investigational study.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elizabeth Manning contact

339-237-2765

liz.manning@angiodynamics.com

6 sites in 1 country

United States6 sites, 6 recruiting

  • University at Buffalo

    Buffalo, New York, 14203

    Monica Nowak, 716-888-4712, monicano@buffalo.edu

    David Zlotnick, MD

    Recruiting

  • Kettering Health

    Kettering, Ohio, 45429

    Chris Seger, 937-395-8365, chris.seger@ketteringhealth.org

    Ammar Safar, MD

    Recruiting

  • Baylor Heart Hospital Plano

    Plano, Texas, 75093

    Christopher Quiocho, 469-814-4735 ext. 44-4735, Christopher.Quiocho@BSWHealth.org

    Sameh Sayfo, MD

    Recruiting

  • CentraCare Heart and Vascular Center

    Saint Cloud, Minnesota, 56303

    Kelly Kobylinski, 320-251-2700 ext. 58316, kelly.kobylinski@centracare.com

    Brian Stegman, MD

    Recruiting

  • Methodist Healthcare

    San Antonio, Texas, 78229

    Susana Mondaca, 210-575-9766, Susana.MondacaBolanos@hcahealthcare.com

    Chandra Kunavarapu, MD

    Recruiting

  • Jacobi Medical Center

    The Bronx, New York, 10461

    Cidney Schultz, 718-918-6212, Cidney.Schultz@nychhc.org

    Seth Sokol, MD

    Recruiting

Other trials in United States

About this study

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)

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.

Read the detailed description

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

Being tested
AlphaReturn Blood Management System
Keywords
pulmonary embolism, alphareturn
Medical subject headings
Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlphaReturn Blood Management SystemDevice

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

Study groups in NCT07280247
Study groupRoleWhat they receive
AlphaVac MMA F1885 System and AlphaReturn Blood Management SystemExperimentalFollowing 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.
Receives: Device: AlphaReturn Blood Management System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through 30 days post-procedure

  2. Rate of Technical Success

    Successful autologous blood transfusion using the AlphaReturn Blood Management System

    Measured: Periprocedural

Secondary outcomes (8)

  1. Rate of Major Adverse Events (MAEs)

    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.

    Measured: Through 48 hours post-procedure

  2. Rate of Complications

    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.

    Measured: Through 48 hours post-procedure

  3. Rate of Device-Related SAEs

    Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post procedure.

    Measured: Through 30 days post-procedure

  4. Rate of Symptomatic PE recurrence within 30 days

    Symptomatic PE recurrence within 30 days.

    Measured: Through 30 days post-procedure

  5. Reduction in RV/LV Ratio

    Reduction in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.

    Measured: Through 48 hours post-procedure

  6. Thrombolytics Use

    Use of thrombolytics during or within 48 hours of the procedure.

    Measured: Through 48 hours post-procedure

  7. Length of Stay in Intensive Care Unit

    Length of stay in the Intensive Care Unit (ICU) within 30 days post-procedure.

    Measured: Through 30 days post-procedure

  8. Length of Stay in Hospital

    Length of stay in the hospital within 30 days post-procedure.

    Measured: Through 30 days post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start30 Mar 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07280247
Sponsor's protocol ID
2025-CAR-03
Acronym
APEX-Return
Status last verified
May 2026
First submitted
25 Nov 2025
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing AlphaReturn Blood Management System in people with Pulmonary Embolism Acute, run by Angiodynamics, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elizabeth Manning (339-237-2765, liz.manning@angiodynamics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Device-Related Adverse Events (AEs) (time frame: Through 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07280247.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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