Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism

Completed · Not applicable

Conditions studied: Pulmonary Embolism, Acute Pulmonary Embolism

In brief

To evaluate the safety and effectiveness of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE).

Key facts

Study ID

NCT05318092

Run by

Angiodynamics, Inc.

People needed

122

Starts

2022-10-19

Expected to finish

2024-01-04

Last updated by the study team

2024-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed and dated informed consent form.
• 18 years of age and older.
• Clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days.
• Diagnosis of pulmonary embolism detected from 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 (BPM) or less prior to the procedure.
• Deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment.

You may not qualify if…

• Excluded from the study if he/she meets any of the following exclusion criteria
• May be pregnant as determined by a positive pregnancy test or who are breastfeeding.
• Has any contraindication to systemic or therapeutic doses of heparin or anticoagulants.
• Has used thrombolytics (tPA) in the past 30 days of baseline CTA.
• Has pulmonary hypertension with peak pulmonary artery pressure (PAP) > 70 mmHg.
• Fraction of inspired oxygen (FiO2) requirement >40% or >6 liters per minute (LPM) to keep oxygen saturations >90%
• Hematocrit <28% within 6 hours of the index procedure.
• Platelets count < 100,000/µL.
• Serum creatinine >1.8 mg/dL.
• International Normalized Ratio (INR) > 3
• Has undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) > 15.
• Presence of cancer requiring active chemotherapy.
• Known bleeding diathesis or coagulation disorder.
• Has had a cardiovascular or pulmonary surgery within the past 7 days of index procedure.
• 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%.
• Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated.
• Requires Vasopressor after fluids to keep pressure ≥ 90 mmHg.
• With left bundle branch block.
• Has intracardiac lead in the right ventricle or atrium.
• Evidence such as imaging or other that suggests the subject is not appropriate for this procedure.
• Has life expectancy < 90 days.
• Dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO).
• Participation in another investigational study

Where it is running

• HonorHealth — Scottsdale, Arizona, United States
• UCLA Health — Los Angeles, California, United States
• Yale University — New Haven, Connecticut, United States
• HCA Memorial Hospital Jacksonville — Jacksonville, Florida, United States
• Emory University at Grady Memorial Hospital — Atlanta, Georgia, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• OSF Healthcare — Peoria, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Community Hospital — Munster, Indiana, United States
• Oshner Medical Center — Jefferson, Louisiana, United States
• CentraCare Heart and Vascular Center — Saint Cloud, Minnesota, United States
• Rutgers University — Newark, New Jersey, United States
• University of Buffalo — Buffalo, New York, United States
• Columbia University Medical Center/NYPH — New York, New York, United States
• Jacobi Medical Center — The Bronx, New York, United States
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Kettering Health — Miamisburg, Ohio, United States
• UPMC Hamot — Erie, Pennsylvania, United States
• Einstein Medical Center — Montgomery, Pennsylvania, United States
• UPMC Pittsburgh — Pittsburgh, Pennsylvania, United States
• Tennova Healthcare -Turkey Creek Medical Center — Knoxville, Tennessee, United States
• Baylor Heart and Vascular Hospital — Dallas, Texas, United States
• Memorial Hermann (University of Texas at Houston) — Houston, Texas, United States
• Methodist Hospital — San Antonio, Texas, United States
• Aurora Health Care — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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