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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
122
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.
HonorHealth
Scottsdale, Arizona, United States
Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA)
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.
Time frame: At 48 hours post-procedure
Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index 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
Time frame: Within 48 hours post-procedure
Use of Thrombolytics Within 48 Hours of the Procedure.
Use of thrombolytics within 48 hours of the procedure.
Time frame: Within 48 hours of the procedure
Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure.
Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure.
Time frame: Within 30 days of the procedure
Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA).
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.
Time frame: At 48 hours post-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.
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Los Angeles, California, United States
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...and 15 more locations
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.
Time frame: Within 48 hours of the procedure
Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure.
Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure.
Time frame: Within 30 days of the procedure
Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days.
Symptomatic PE recurrence within 30 days.
Time frame: Within 30 days of the procedure