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
Qualifiers
≥ 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
Treatments tested in this trial
- Laguna Thrombectomy System
Treatment groups
107 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov