Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness
NCT ID: NCT07280247
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
39 participants
INTERVENTIONAL
2026-03-31
2026-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluating the Efficacy, Safety and Long Term Functional Outcomes of Percutaneous Mechanical Aspiration Thrombectomy for Treatment of Acute Pulmonary Embolism Using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
NCT06697314
Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism
NCT05318092
Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism
NCT02396758
Mechanical Thrombectomy for Acute Pulmonary Embolism
NCT07032025
Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II
NCT06576427
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AlphaVac MMA F1885 System and AlphaReturn Blood Management System
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.
AlphaReturn Blood Management System
The AlphaReturn Blood Management System allows for autologous injection of aspirated blood from an AlphaVac MMA System thrombectomy procedure.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AlphaReturn Blood Management System
The AlphaReturn Blood Management System allows for autologous injection of aspirated blood from an AlphaVac MMA System thrombectomy procedure.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subject is 18 years of age and older.
3. Subject presents clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days.
4. Subject has a diagnosis of pulmonary embolism detected from computed tomography angiography (CTA).
5. Subject has a RV/LV ratio of 0.9 or higher.
6. Subject has a systolic blood pressure (SBP) of 90mmHg or higher.
7. Subject has a heart rate of 130 beats per minute (BPM) or less prior to the procedure.
8. Subject is deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment.
Exclusion Criteria
2. Subjects who have any contraindication to systemic or therapeutic doses of heparin or anticoagulants.
3. Subjects who have used thrombolytics in the 30 days prior to the baseline CTA.
4. Subjects who have pulmonary hypertension with peak pulmonary artery pressure (PAP) \> 70 mmHg.
5. Subjects who have FiO2 requirement \> 44% or \> 6 LPM to keep oxygen saturations \> 90%.
6. Subjects with hematocrit \< 28% within 6 hours of index procedure.
7. Subjects with platelets count \< 100,000/μL.
8. Subjects with serum creatinine \> 1.8 mg/dL.
9. Subjects with International Normalized Ratio (INR) \> 3.
10. Subjects who have undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) \> 15.
11. Subjects with the presence of cancer requiring active chemotherapy.
12. Subjects with known bleeding diathesis or coagulation disorder.
13. Subjects who have had a cardiovascular or pulmonary surgery within the past 7 days of index procedure.
14. 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%.
15. Subjects with known anaphylactic reaction to radiographic contrast agents that cannot be pretreated.
16. Subject requires vasopressor after fluids to keep pressure ≥ 90mmHg.
17. Subjects with left bundle branch block.
18. Subjects who have intracardiac lead in the right ventricle or atrium.
19. Evidence such as imaging or other that suggest the subject is not appropriate for this procedure.
20. Subjects that have life expectancy \< 90 days, in the opinion of the investigator at the time of enrollment.
21. Subjects dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO).
22. Participation in another investigational study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Angiodynamics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-CAR-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.