Actively Recruiting
Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness
Led by Angiodynamics, Inc. · Updated on 2026-05-11
39
Participants Needed
6
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official 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 provided
- 18 years of age or older
- Clinical signs and symptoms of acute intermediate-risk pulmonary embolism for 14 days or less
- Pulmonary embolism diagnosis 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 procedures per institutional guidelines or clinical judgment
You will not qualify if you...
- Pregnant or breastfeeding
- Contraindications to systemic or therapeutic doses of heparin or anticoagulants
- Use of thrombolytics within 30 days before baseline CTA
- Pulmonary hypertension with peak pulmonary artery pressure (PAP) above 70 mmHg
- Oxygen requirement exceeding 44% FiO2 or more than 6 LPM to maintain oxygen saturation above 90%
- Hematocrit below 28% within 6 hours before procedure
- Platelet count below 100,000/µL
- Serum creatinine above 1.8 mg/dL
- International Normalized Ratio (INR) above 3
- Major trauma within 14 days before procedure with Injury Severity Score over 15
- Active cancer requiring chemotherapy
- Known bleeding or coagulation disorders
- Cardiovascular or pulmonary surgery within 7 days before procedure
- 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
- Anaphylactic reaction to radiographic contrast agents without pretreatment
- Need for vasopressors after fluids to maintain blood pressure 90 mmHg or higher
- Left bundle branch block
- Presence of intracardiac lead in right ventricle or atrium
- Imaging or other evidence indicating unsuitability for the procedure
- Life expectancy less than 90 days
- Dependence on extracorporeal life support such as ECMO
- Participation in another investigational study
AI-Screening
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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
CONTACT
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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