Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

Recruiting N/A Interventional Study
Pulmonary Embolism
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
107 (estimated)
Sponsor
Innova Vascular, Inc. · Industry
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About 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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. ≥ 18 years of age; \< 85 years old 2. RV/LV ratio \> 0.9 as determined by CTA 3. Systolic blood pressure \> 90 mmHg 4. Heart rate ≤ 120 5. Patient is deemed eligible for procedure by the interventional investigator 6. CTA evidence of proximal PE (filling defect in at least on…
Contacts

Sanjay Shrivastava, Ph.D.

949-295-6040

ss@innovavascular.com

CONTACT