Laguna Thrombectomy System for Pulmonary Embolism
(TRUST Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Innova Vascular, Inc.

No Placebo Group

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.

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

I am between 18 and 85 years old.

RV/LV ratio > 0.9 as determined by CTA

Heart rate ≤ 120

+4 more

Exclusion Criteria

International Normalized Ratio (INR): > 3

Systolic pulmonary artery pressure > 70 mmHg on initial invasive hemodynamic assessments

Hematocrit: < 28%

+21 more

Participant Groups

The TRUST trial is testing the Laguna Thrombectomy System, an experimental device designed to remove clots from lung arteries in patients with PE. It includes two components: the Laguna Clot Retriever™ and Malibu Aspiration Catheter™, both made by Innova Vascular, Inc.

1Treatment groups

Experimental Treatment

Group I: Laguna Thrombectomy SystemExperimental Treatment1 Intervention