ClotTriever Outcomes (CLOUT) Registry

Inari Medical499 enrolled

Overview

Evaluate real world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity deep vein thrombosis (DVT) with the ClotTriever Thrombectomy System.

The CLOUT Registry is a prospective, multi-center, observational registry of subjects with proximal lower extremity DVT treated with the ClotTriever Thrombectomy System. The Registry will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through 2 years of follow-up.

Study Type

OBSERVATIONAL

Enrollment

499

Conditions

Deep Vein Thrombosis Leg DVT Chronic DVT of Lower Extremity Acute DVT of Lower Extremity

Interventions

ClotTrieverDEVICE

Thrombectomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Proximal lower extremity DVT involving the femoral, common femoral, iliac veins, or inferior vena cava (IVC), alone or in combination. * Willing and able to provide informed consent. Exclusion Criteria: * Prior venous stent in the target venous segment * IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins * IVC filter in place at the time of the planned index procedure * Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used * Life expectancy less than 1 year * Chronic non-ambulatory status * Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically-managed throughout the study period * Unavailability of a lower extremity venous access site

Locations (43)

Outcomes

Primary Outcomes

Primary Safety Endpoint: Proportion Participants With Major Adverse Events

The primary safety endpoint is the proportion of participants with Major Adverse Events (MAE). MAEs are defined as a composite endpoint triggered when any of four categories of events occurred through 30 days after the index procedure, as observed in the Primary Safety Cohort (the composite endpoints were not observed for the Full Analysis Population: * All-cause mortality * Major bleeding * New symptomatic pulmonary embolism (PE) documented by computed tomography pulmonary angiography (CTPA) * Rethrombosis of a target vessel segment (TVS)

Time frame: 30 days

Secondary Outcomes

Primary Effectiveness Endpoint (Primary Effectiveness Cohort): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus

Complete or near complete (≥75%) removal of venous thrombus from the TVS, as determined by the percent reduction in the Marder score for those segments. When more than one venous segment is treated, the change in Marder score is calculated as the total score for the treated segments prior to intervention with the study device (baseline score) minus the total score after treatment with the study device but before treatment with any adjunctive devices or pharmacologic agents (post-treatment score), divided by the baseline score.

Time frame: Index Procedure (approximately 0.5 hours on day 0)

Data from ClinicalTrials.gov

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St. Vincent's East

Birmingham, Alabama, United States

Affinity Cardiovascular Specialists

Birmingham, Alabama, United States

University of California, Los Angeles

Los Angeles, California, United States

Vascular and Interventional Specialists of Orange County

Orange, California, United States

University of Colorado, Denver

Denver, Colorado, United States

Yale University

New Haven, Connecticut, United States

MedStar Health Research Institution

Washington D.C., District of Columbia, United States

Manatee Memorial Hospital

Bradenton, Florida, United States

Memorial Hospital Jacksonville

Jacksonville, Florida, United States

Lakeland Vascular Institute

Lakeland, Florida, United States

...and 33 more locations