Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
Condition(s) studied
Investigational drug(s) / intervention(s)
Laguna Thrombectomy System: Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism
Study 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
Primary outcome measure(s)
- A composite of the following major adverse events occurring within 48 (± 8) hours post-procedure: — within 48 (± 8) hours post-procedure
* Device-related death within 48 (± 8) hours post-procedure * Major bleeding as defined by GUSTO (moderate or severe) within 48 (± 8) hours post-procedure. * The following treatment-related adverse events within 48 (± 8) hours post-procedure: * Cardio-respiratory deterioration, * Pulmonary vascular injury, and/or * Cardiac injury - Reduction in RV/LV ratio from baseline to 48 (± 8) hours (or at discharge, whichever occurs first) as assessed by Computed Tomography Angiography (CTA) — from baseline to 48 (± 8) hours (or at discharge, whichever occurs first)
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Grandview Medical Center | Birmingham | Alabama | Recruiting |
| University of Arizona | Tucson | Arizona | Recruiting |
| University of California Irvine | Irvine | California | Recruiting |
| Memorial Care Long Beach Medical Center | Long Beach | California | Recruiting |
| Mission Hospital Regional Medical Center | Mission Viejo | California | Recruiting |
| St. Joseph Hospital of Orange | Orange | California | Recruiting |
| George Washington University | Washington D.C. | District of Columbia | Recruiting |
| Manatee Memorial Hospital | Bradenton | Florida | Recruiting |
| Physicians Regional Medical Center | Naples | Florida | Recruiting |
| AdventHealth Tampa | Tampa | Florida | Completed |
| Rush University Medical Center | Chicago | Illinois | Completed |
| Albany Medical Center | Albany | New York | Completed |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | Recruiting |
| OhioHealth Research Institute | Columbus | Ohio | Recruiting |
| Turkey Creek Medical Center | Knoxville | Tennessee | Recruiting |
| University of Texas Southwestern | Dallas | Texas | Recruiting |
| Ankara Bilkent City Hospital | Ankara | Turkey (Türkiye) | Completed |
| Ankara Etlik City Hospital | Ankara | Turkey (Türkiye) | Completed |
| Hacettepe University Hospital | Ankara | Turkey (Türkiye) | Completed |
| Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital | Istanbul | Turkey (Türkiye) | Completed |
| Dokuz Eylul University Research and Application Hospital | Izmir | Turkey (Türkiye) | Completed |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06041594 on ClinicalTrials.gov ↗ ← All trials in the USA