Laguna Thrombectomy System for Pulmonary Embolism
(TRUST Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have had any fibrinolytic agents (medications that dissolve blood clots) in the last 30 days. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the Laguna Thrombectomy System treatment for pulmonary embolism?
The research suggests that catheter-directed interventions, like the Laguna Thrombectomy System, can be effective for treating pulmonary embolism, as similar treatments have shown improved patient outcomes and reduced hospital stays. Additionally, the use of aspiration thrombectomy combined with low-dose thrombolysis has been evaluated for safety and efficacy in treating acute unstable pulmonary embolism.12345
Is the Laguna Thrombectomy System generally safe for use in humans?
How is the Laguna Thrombectomy System treatment different from other treatments for pulmonary embolism?
The Laguna Thrombectomy System is unique because it likely offers a mechanical approach to removing blood clots in the lungs, similar to the Inari FlowTriever System, which removes clots without the need for clot-dissolving drugs, reducing the risk of bleeding associated with those medications.311121314
Eligibility Criteria
Adults aged 18-85 with a recent pulmonary embolism (PE), which is a blockage in the lung arteries, can join this trial. They must have certain heart and blood pressure levels and be considered fit for the procedure by a specialist. People are excluded if they don't meet these health criteria or have other conditions not listed here.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the Laguna Thrombectomy procedure for the treatment of pulmonary embolism
Immediate Post-procedure Monitoring
Participants are monitored for major adverse events within 48 (± 8) hours post-procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Laguna Thrombectomy System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Innova Vascular, Inc.
Lead Sponsor