Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism
NCT ID: NCT05318092
Last Updated: 2024-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
2022-10-19
2024-01-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for the treatment of acute pulmonary embolism
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
The AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE has five main components, a flexible cannula (F1885), sheath, tapered obturator, aspirator handle, and waste bag.
Interventions
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AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
The AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE has five main components, a flexible cannula (F1885), sheath, tapered obturator, aspirator handle, and waste bag.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Angiodynamics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2021-EVT-01
Identifier Type: -
Identifier Source: org_study_id
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