Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a prospective, multi-center, pivotal study to demonstrate the safety and effectiveness of the Laguna Thrombectomy System for the treatment of pulmonary embolism. The Laguna Thrombectomy System is an investigational device which consists of the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System. These devices are manufactured by Innova Vascular, Inc.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• ≥ 18 years of age; \< 85 years old
• RV/LV ratio \> 0.9 as determined by CTA
• Systolic blood pressure \> 90 mmHg
• Heart rate ≤ 120
• Patient is deemed eligible for procedure by the interventional investigator
• CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
• PE Symptom duration ≤ 14 days
Locations
United States
California
University of California Irvine
RECRUITING
Irvine
Memorial Care Long Beach Medical Center
RECRUITING
Long Beach
Mission Hospital Regional Medical Center
RECRUITING
Mission Viejo
St. Joseph Hospital of Orange
RECRUITING
Orange
Washington, D.c.
George Washington University
RECRUITING
Washington D.c.
Florida
Manatee Memorial Hospital
RECRUITING
Bradenton
AdventHealth Tampa
RECRUITING
Tampa
Illinois
Rush University Medical Center
RECRUITING
Chicago
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New York
Albany Medical Center
RECRUITING
Albany
Other Locations
Turkey
Ankara Bilkent City Hospital
RECRUITING
Ankara
Hacettepe University Hospital
RECRUITING
Ankara
Sancaktepe Sehit Prof. Dr. Ilhan Varan Training and Research Hospital
RECRUITING
Istanbul
Dokuz Eylul University Research and Application Hospital
RECRUITING
Izmir
Contact Information
Primary
Sanjay Shrivastava, Ph.D.
ss@innovavascular.com
949-295-6040
Time Frame
Start Date: 2024-08-19
Estimated Completion Date: 2026-04
Participants
Target number of participants: 107
Treatments
Experimental: Laguna Thrombectomy System
Related Therapeutic Areas
Sponsors
Leads: Innova Vascular, Inc.