What is the AlphaReturn Blood Management System studying for acute pulmonary embolism?

The study is evaluating the safety and effectiveness of the AlphaReturn Blood Management System used with the AlphaVac MMA System in treating acute pulmonary embolism. Researchers aim to understand how well the device performs during and after the procedure. This research is led by Angiodynamics, Inc. to improve treatment options for patients with this condition.

Who may be eligible for this acute pulmonary embolism clinical trial?

Adults 18 years and older with a diagnosis of acute intermediate-risk pulmonary embolism confirmed by CTA may be eligible. Participants should have specific heart rate and blood pressure ranges and be medically suitable for the procedure. This trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this acute pulmonary embolism clinical trial?

Study-related care, including the use of the investigational devices and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07280247

Study of Safety and Effectiveness of AlphaVac Mechanical Aspiration and AlphaReturn Blood Management Systems for Treating Acute Pulmonary Embolism in Adults

Led by Angiodynamics, Inc. · Updated on 2026-05-11

Participants Needed

Research Sites

N/A

Total Duration

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 RVLV 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 procedures 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

Age: 18Years +

All Genders

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.

Research Team

Elizabeth Manning

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Study of Safety and Effectiveness of AlphaVac Mechanical Aspiration and AlphaReturn Blood Management Systems for Treating Acute Pulmonary Embolism in Adults

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria