An interventional study of AlphaReturn Blood Management System in Pulmonary Embolism Acute, sponsored by Angiodynamics, Inc.. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Angiodynamics, Inc. · Not applicable, Interventional, and Treatment
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.
This is a prospective, multicenter, single-arm investigational device study evaluating safety and effectiveness.
832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.
This study's planned enrollment of 39 is below the median of 174 across 429 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Angiodynamics, Inc. is the lead sponsor of 22 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A potential subject will be included in the study if he/she meets all the following inclusion criteria:
Exclusion Criteria:
A potential subject will be excluded from the study if he/she meets any of the following exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Through 30 days post-procedure
Rate of Technical Success
Successful autologous blood transfusion using the AlphaReturn Blood Management System
Time frame: Periprocedural
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.
Time frame: Through 48 hours post-procedure
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.
Time frame: Through 48 hours post-procedure
Rate of Device-Related SAEs
Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post procedure.
Time frame: Through 30 days post-procedure
Rate of Symptomatic PE recurrence within 30 days
Symptomatic PE recurrence within 30 days.
Time frame: Through 30 days post-procedure
Reduction in RV/LV Ratio
Reduction in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.
Time frame: Through 48 hours post-procedure
Thrombolytics Use
Use of thrombolytics during or within 48 hours of the procedure.
Time frame: Through 48 hours post-procedure
Length of Stay in Intensive Care Unit
Length of stay in the Intensive Care Unit (ICU) within 30 days post-procedure.
Time frame: Through 30 days post-procedure
Length of Stay in Hospital
Length of stay in the hospital within 30 days post-procedure.
Time frame: Through 30 days post-procedure
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
Of 150 interventional studies with no phase under Pulmonary Embolism, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
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