AlphaVac aspiration with AlphaReturn blood management for acute pulmonary embolism

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

This tries to see if using the AlphaVac mechanical aspiration device together with the AlphaReturn blood management system is safe and works for adults who have acute intermediate-risk pulmonary embolism.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Angiodynamics, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 6 sites (Saint Cloud, Minnesota and 5 other locations)
• Trial ID: NCT07280247 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, single-arm investigational device study treating adults with acute intermediate‑risk pulmonary embolism using the AlphaVac mechanical aspiration system together with the AlphaReturn blood management system. Eligible participants must have PE confirmed by CT angiography, present within 14 days of symptom onset, have an RV/LV ratio ≥0.9, systolic blood pressure ≥90 mmHg, and heart rate ≤130 bpm, and be judged eligible for an interventional procedure. The procedure uses mechanical aspiration to remove clot while AlphaReturn manages blood during the intervention. Investigators will follow patients for device-related safety events and measures of effectiveness such as thrombus reduction and right ventricular function over follow-up.

Who should consider this trial

Good fit: Adults aged 18 and older with CTA-confirmed acute intermediate‑risk pulmonary embolism within 14 days, RV/LV ratio ≥0.9, systolic BP ≥90 mmHg, heart rate ≤130 bpm, and deemed eligible for an interventional procedure are ideal candidates.

Not a fit: Patients who are pregnant, hemodynamically unstable (systolic BP <90 mmHg), have contraindications to interventional procedures, present beyond 14 days, or otherwise fail to meet inclusion criteria are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could remove pulmonary clots with less blood loss and improve right‑heart function, potentially shortening recovery.

How similar studies have performed: Other mechanical aspiration and catheter-based thrombectomy devices have shown promise in single-arm studies and registries for reducing thrombus burden and improving RV function, but the specific combination with AlphaReturn is novel and not yet proven in randomized trials.

Eligibility criteria

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.

Where this trial is running

Saint Cloud, Minnesota and 5 other locations

• CentraCare Heart and Vascular Center — Saint Cloud, Minnesota, United States (Recruiting)
• University at Buffalo — Buffalo, New York, United States (Recruiting)
• Jacobi Medical Center — The Bronx, New York, United States (Recruiting)
• Kettering Health — Kettering, Ohio, United States (Recruiting)
• Baylor Heart Hospital Plano — Plano, Texas, United States (Recruiting)
• Methodist Healthcare — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Elizabeth Manning

Conditions Pulmonary Embolism Acute; pulmonary embolism; alphareturn