A Prospective, Multicenter Study to Evaluate the Safety and Efficacy of an Aspiration Thrombectomy System in Acute Pulmonary Embolism
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• At least 18 years of age at the time of consent
• Clinical signs, symptoms, and presentation consistent with acute PE
• Onset of PE symptoms occurred within 14 days of presentation
• Filling defect in at least one main or lobar pulmonary artery evidenced by CTA
• RV dysfunction on CTA or echocardiography defined as RV/LV ratio \>0.9
Locations
United States
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Washington, D.c.
Medstar Health Research Institute
RECRUITING
Washington D.c.
Florida
Ascension Sacred Heart Hospital
RECRUITING
Pensacola
Illinois
Insight Hospital and Medical Center
RECRUITING
Chicago
Indiana
Ascension St. Vincent Hospital
RECRUITING
Indianapolis
Indiana University
RECRUITING
Indianapolis
Massachusetts
UMass Chan Medical School
RECRUITING
Worcester
New Jersey
Rutgers New Jersey Medical School
RECRUITING
Newark
Nevada
University Medical Center of Southern Nevada
RECRUITING
Las Vegas
New York
University at Buffalo
RECRUITING
Buffalo
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
Promedica Toledo Hospital
RECRUITING
Toledo
Oklahoma
Ascension St. John Jane Phillips Medical Center
RECRUITING
Bartlesville
Ascension St. John Hospital
RECRUITING
Tulsa
Texas
Baylor Scott & White The Heart Hospital - Plano
RECRUITING
Plano
Contact Information
Primary
Danyel C Carr, MS
Clinical@argonmedical.com
4697311421
Backup
Holly Harrison
4697313561
Time Frame
Start Date: 2025-01-03
Estimated Completion Date: 2026-09-23
Participants
Target number of participants: 125
Treatments
Experimental: Mechanical Thrombectomy via Cleaner Pro
Participants will receive catheter-directed therapy via mechanical aspiration thrombectomy for the treatment of pulmonary embolism (PE) using the Cleaner Pro Thrombectomy System.
Related Therapeutic Areas
Sponsors
Leads: Argon Medical Devices
Collaborators: NAMSA