To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
The Cleaner™ Pro Thrombectomy System ("Cleaner Pro") is a catheter-based aspiration thrombectomy device comprised of a handpiece, an aspiration catheter, a dilator, and an aspiration canister.
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGChange in Right Ventricle (RV)/Left Ventricle (LV) Ratio
Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.
Time frame: At 48 hours post-procedure
Rate of Major Adverse Events (MAEs)
Rate of MAEs within the first 48 hours after the index procedure, defined as: Device-related death Major bleeding, and Device-related Serious Adverse Events which includes clinical deterioration, pulmonary vascular injury, and cardiac injury.
Time frame: At 48 hours post-procedure
Rate of device-related complications and device-related death
Rate of device-related complications including major bleeding, clinical deterioration, pulmonary vascular injury, and cardiac injury, and device-related death within 48 hours of the index procedure.
Time frame: Within 48 hours of the procedure
Rate of device-related SAEs and all-cause mortality
Rate of device-related serious adverse events (SAEs) and death for any cause within 30 days post-procedure.
Time frame: Within 30 days of procedure
Rate of Symptomatic PE Recurrence
Rate of Symptomatic PE recurrence within 30 days.
Time frame: Within 30 days of the procedure
Volume of blood aspirated
The amount of blood aspirated during the procedure.
Time frame: At index procedure
Use of thrombolytics
Use of thrombolytics within 48 hours of the procedure.
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Medstar Health Research Institute
Washington D.C., District of Columbia, United States
RECRUITINGAscension Sacred Heart Hospital
Pensacola, Florida, United States
RECRUITINGBayCare Health System
Tampa, Florida, United States
RECRUITINGInsight Hospital and Medical Center
Chicago, Illinois, United States
RECRUITINGIndiana University
Indianapolis, Indiana, United States
RECRUITINGAscension St. Vincent Hospital
Indianapolis, Indiana, United States
RECRUITINGUMass Chan Medical School
Worcester, Massachusetts, United States
RECRUITINGUniversity Medical Center of Southern Nevada
Las Vegas, Nevada, United States
RECRUITINGUniversity at Buffalo
Buffalo, New York, United States
RECRUITING...and 7 more locations
Time frame: Within 48 hours of the procedure
Change in Modified Miller Index
Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA. This index score quantifies arterial obstruction in pulmonary embolism. The higher the score, the more perfusion is reduced.
Time frame: At 48 hours post-procedure
Quality of Life assessed via PEmb-QoL
Self-assessment of PE-related complaints and daily living limitations (including work and social). The PEmb-QoL measures 6 dimensions, with higher scores being worse.
Time frame: At 30 days post-procedure
Quality of Life assessed via EQ-5D-5L
Self-assessment of activities for daily living. The EQ-5D-5L measures 5 dimensions, with higher scores being worse.
Time frame: At 30 days post-procedure