A prospective, multi-center, single-arm, non-blinded trial is designed to evaluate the safety and efficacy of the AVENTUS Thrombectomy System in patients with acute pulmonary embolism.
Evaluate the safety and efficacy of the AVENTUS Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.
A prospective, multi-center, single-arm, non-blinded pivotal study. The study will consist of up to 120 subjects across up to 35 sites in the U.S. Subjects will be followed for 30 days (±7 days).
Efficacy will be measured by core lab adjudicated change in RV/LV ratio from baseline to 48 hours (± 8 hours) postindex procedure as measured by CTA.
Efficacy will be measured by core lab adjudicated change in RV/LV ratio from baseline to 48 hours (± 8 hours) postindex procedure as measured by CTA.
Visit https://clinicaltrials.gov/study/NCT05907564 for more information. If you are a healthcare professional and want to learn more about this clinical trial, email clinical@inquismedical.com.
Visit https://clinicaltrials.gov/study
/NCT05907564 for more information. If you are a healthcare professional and want to learn more about this clinical trial, email clinical@inquismedical.com.
*CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use.
University Hospitals
Cleveland, OH
Ohio Health
Columbus, OH
Northwestern University
Chicago, IL
Long Beach Medical Center
Long Beach, CA
NorthBay Health Medical Center
Fairfield, CA
Alexian Brothers Medical Center
Elk Grove Village, IL
ProMedica Toledo Hospital
Toledo, OH
Atlanta, GA
Ascension Texas Cardiovascular
Austin, TX
Detroit, MI
El Camino Health
Mountain View, CA
Honor Health
Scottsdale, AZ
Southfield, MI
McLaren Healthcare
Bay City, MI
Washington, DC
Holy Name
Teaneck, NJ
Hackensack University Medical Center
Hackensack, NJ
Centennial Medical Center
Nashville, TN
Ascension St. John Bartlesville
Bartlesville, OK
Ascension St. John Tulsa
Tulsa, OK
CentraCare Heart and Vascular
St. Cloud, MN
Ascension St. Vincent
Indianapolis, IN
Miriam Hospital
Providence, RI
Mt. Sinai Medical Center
New York, NY
Ochsner Medical Center
New Orleans, LA
Hartford Hospital
Hartford, CT
Sutter Health
Sacramento, CA
AVENTUS Thrombectomy System
Indications for Use: The AVENTUS Thrombectomy System is indicated for:
The AVENTUS Thrombectomy System is intended for use in the peripheral vasculature.
The AVENTUS Clot Management System is indicated for use with the AVENTUS Thrombectomy System for autologous blood transfusion.
AVENTUS Thrombectomy System
Indications for Use: The AVENTUS Thrombectomy System is indicated for:
The AVENTUS Thrombectomy System is intended for use in the peripheral vasculature.
The AVENTUS Clot Management System is indicated for use with the AVENTUS Thrombectomy System for autologous blood transfusion.
