Actively Recruiting
Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness (APEX-Return)
Led by Angiodynamics, Inc. · Updated on 2026-05-11
39
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the AlphaReturn Blood Management System used together with the AlphaVac Multipurpose Mechanical Aspiration (MMA) System for treating acute pulmonary embolism. This prospective, multicenter, single-arm study focuses on patients with acute intermediate-risk pulmonary embolism confirmed by computed tomography angiography (CTA) and specific clinical signs. The study aims to assess device-related adverse events and the technical success of the procedure. Participants will undergo mechanical thrombectomy using the AlphaVac MMA System. After the procedure, the aspirated blood will be filtered through the AlphaReturn Blood Management System and reinfused back into the patient. This investigational device study involves a single treatment group using these combined systems to manage blood during the intervention. During the study, participants will be closely monitored for device-related adverse events up to 30 days after the procedure. Additional assessments include tracking major adverse events, complications, symptomatic pulmonary embolism recurrence, reduction in right ventricle to left ventricle (RV/LV) ratio, use of thrombolytics, and length of stay in intensive care and hospital. Safety and effectiveness outcomes will be collected throughout the follow-up period to evaluate the procedure's impact and participant health.
CONDITIONS
Brief Title
Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form.
- 18 years of age or older.
- Clinical signs and symptoms of acute intermediate-risk pulmonary embolism for 14 days or less.
- Diagnosis of pulmonary embolism confirmed by computed tomography angiography (CTA).
- Right ventricle to left ventricle (RV/LV) ratio of 0.9 or higher.
- Systolic blood pressure (SBP) of 90 mmHg or higher.
- Heart rate of 130 beats per minute or less before the procedure.
- Medically eligible for interventional procedure(s) according to institutional guidelines or clinical judgment.
You will not qualify if you...
- Pregnant or breastfeeding.
- Contraindication to systemic or therapeutic doses of heparin or anticoagulants.
- Use of thrombolytics within 30 days prior to baseline CTA.
- Pulmonary hypertension with peak pulmonary artery pressure over 70 mmHg.
- FiO2 requirement greater than 44% or over 6 LPM to maintain oxygen saturation above 90%.
- Hematocrit less than 28% within 6 hours of the procedure.
- Platelet count less than 100,000/µL.
- Serum creatinine greater than 1.8 mg/dL.
- International Normalized Ratio (INR) greater than 3.
- Major trauma within the past 14 days with Injury Severity Score over 15.
- Active cancer requiring chemotherapy.
- Known bleeding or coagulation disorders.
- Cardiovascular or pulmonary surgery within the past 7 days.
- Severe or chronic pulmonary hypertension, uncompensated heart failure, chest irradiation, oxygen-dependent lung disease, heparin-induced thrombocytopenia, or chronic left heart disease with ejection fraction 30% or less.
- Known anaphylactic reaction to contrast agents that cannot be pretreated.
- Need for vasopressors after fluids to maintain blood pressure at or above 90 mmHg.
- Left bundle branch block.
- Presence of intracardiac lead in the right ventricle or atrium.
- Imaging or other evidence that the procedure is inappropriate.
- Life expectancy less than 90 days.
- Dependence on extracorporeal life support like ECMO.
- Participation in another investigational study.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Periprocedural
Participants undergo mechanical thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration System followed by filtration and reinfusion of autologous blood using the AlphaReturn Blood Management System.
1 procedure visit (in-person)
Duration - 30 days post-procedure
Participants are monitored for safety and effectiveness outcomes including adverse events and recovery over 30 days post-procedure.
Approximately 3 to 5 follow-up visits
Trial Site Locations
Total: 6 locations
1
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, United States, 56303
Actively Recruiting
2
University at Buffalo
Buffalo, New York, United States, 14203
Actively Recruiting
3
Jacobi Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
4
Kettering Health
Kettering, Ohio, United States, 45429
Actively Recruiting
5
Baylor Heart Hospital Plano
Plano, Texas, United States, 75093
Actively Recruiting
6
Methodist Healthcare
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
E
Elizabeth Manning
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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