Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism
- Conditions
- Pulmonary EmbolismAcute Pulmonary Embolism
- Interventions
- Device: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
- Registration Number
- NCT05318092
- Lead Sponsor
- Angiodynamics, Inc.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
- 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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE 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
- Primary Outcome Measures
Name Time Method Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA) At 48 hours post-procedure Change in Right Ventricle to Left Ventricle (RV/LV) ratio between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the study's core lab.
Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure. Within 48 hours post-procedure Rate of Major Adverse Events (MAEs) within the first 48 hours after the index procedure, defined as:
Device-related death Major bleeding
Device-related SAEs of:
* Clinical Deterioration
* Pulmonary Vascular Injury
* Cardiac Injury
- Secondary Outcome Measures
Name Time Method Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA). At 48 hours post-procedure Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the study's core lab. Modified Miller Index ranges from 0 - 16 (higher values mean higher thrombus burden) and a greater negative change is a better outcome.
Use of Thrombolytics Within 48 Hours of the Procedure. Within 48 hours of the procedure Use of thrombolytics within 48 hours of the procedure.
Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days. Within 30 days of the procedure Symptomatic PE recurrence within 30 days.
Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure. Within 48 hours of the procedure Rate of device related complications including clinical deterioration, cardiac injury, pulmonary vascular injury, major bleeding, and device-related death within 48 hours of the index procedure.
Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure. Within 30 days of the procedure Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure.
Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure. Within 30 days of the procedure Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure.
Trial Locations
- Locations (25)
UCLA Health
🇺🇸Los Angeles, California, United States
Emory University at Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
UPMC Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Community Hospital
🇺🇸Munster, Indiana, United States
Oshner Medical Center
🇺🇸Jefferson, Louisiana, United States
Tennova Healthcare -Turkey Creek Medical Center
🇺🇸Knoxville, Tennessee, United States
OSF Healthcare
🇺🇸Peoria, Illinois, United States
Kettering Health
🇺🇸Miamisburg, Ohio, United States
HonorHealth
🇺🇸Scottsdale, Arizona, United States
Rutgers University
🇺🇸Newark, New Jersey, United States
Yale University
🇺🇸New Haven, Connecticut, United States
UPMC Hamot
🇺🇸Erie, Pennsylvania, United States
Einstein Medical Center
🇺🇸Montgomery, Pennsylvania, United States
HCA Memorial Hospital Jacksonville
🇺🇸Jacksonville, Florida, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
CentraCare Heart and Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
Columbia University Medical Center/NYPH
🇺🇸New York, New York, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
University of Buffalo
🇺🇸Buffalo, New York, United States
Baylor Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
Aurora Health Care
🇺🇸Milwaukee, Wisconsin, United States
Memorial Hermann (University of Texas at Houston)
🇺🇸Houston, Texas, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Methodist Hospital
🇺🇸San Antonio, Texas, United States