Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
Status: Recruiting
Location: See all (21) 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
Alabama
Grandview Medical Center
RECRUITING
Birmingham
Arizona
University of Arizona
RECRUITING
Tucson
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
Physicians Regional Medical Center
RECRUITING
Naples
AdventHealth Tampa
COMPLETED
Tampa
Illinois
Rush University Medical Center
COMPLETED
Chicago
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New York
Albany Medical Center
COMPLETED
Albany
Ohio
OhioHealth Research Institute
RECRUITING
Columbus
Tennessee
Turkey Creek Medical Center
RECRUITING
Knoxville
Texas
University of Texas Southwestern
RECRUITING
Dallas
Other Locations
Turkey
Ankara Bilkent City Hospital
COMPLETED
Ankara
Ankara Etlik City Hospital
COMPLETED
Ankara
Hacettepe University Hospital
COMPLETED
Ankara
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
COMPLETED
Istanbul
Dokuz Eylul University Research and Application Hospital
COMPLETED
Izmir
Contact Information
Primary
Sanjay Shrivastava, Ph.D.
ss@innovavascular.com
949-295-6040
Time Frame
Start Date: 2024-08-19
Estimated Completion Date: 2026-09
Participants
Target number of participants: 107
Treatments
Experimental: Laguna Thrombectomy System
Related Therapeutic Areas
Sponsors
Leads: Innova Vascular, Inc.