NCT07280247 · 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)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- 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.
Exclusion criteria
- 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%.
- 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.
Where
- Saint Cloud, Minnesota
- Buffalo, New York
- The Bronx, New York
- Kettering, Ohio
- Plano, Texas
- San Antonio, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations