Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
ConditionPulmonary Embolism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorInnova Vascular, Inc.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years of age; < 85 years old
RV/LV ratio > 0.9 as determined by CTA
Systolic blood pressure > 90 mmHg
Heart rate ≤ 120
Disqualifiers
Systolic pulmonary artery pressure > 70 mmHg on initial invasive hemodynamic assessments
Life expectancy of < 90 days in the opinion of investigator at the time of enrollment
Subject pregnant or breast feeding
Current participation in another drug or medical device treatment study
Trial design
Design model
Single group
Treatments tested in this trial
Laguna Thrombectomy System
DeviceRemoval of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism
Treatment groups
107 Participants
are divided into 1 treatment groupGroup A: Laguna Thrombectomy SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
A composite of the following major adverse events occurring 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
Time frame
within 48 (± 8) hours post-procedure2
Reduction in RV/LV ratio from baseline to 48 (± 8) hours (or at discharge, whichever occurs first) as assessed by Computed Tomography Angiography (CTA)
Time frame
from baseline to 48 (± 8) hours (or at discharge, whichever occurs first)Sponsors and contacts
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Source ClinicalTrials.gov