ClotTriever Outcomes (CLOUT) Registry (CLOUT)

August 22, 2025 updated by: Inari Medical
Evaluate real world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity deep vein thrombosis (DVT) with the ClotTriever Thrombectomy System.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 (Actual)

499

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • St. Vincent's East
      • Birmingham, Alabama, United States, 35243
        • Affinity Cardiovascular Specialists
    • California
      • Los Angeles, California, United States, 90024
        • University of California, Los Angeles
      • Orange, California, United States, 92868
        • Vascular and Interventional Specialists of Orange County
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado, Denver
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • MedStar Health Research Institution
    • Florida
      • Bradenton, Florida, United States, 34208
        • Manatee Memorial Hospital
      • Jacksonville, Florida, United States, 32216
        • Memorial Hospital Jacksonville
      • Lakeland, Florida, United States, 33801
        • Lakeland Vascular Institute
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center of Florida
      • Tampa, Florida, United States, 33613
        • AdventHealth Tampa
    • Georgia
      • Gainesville, Georgia, United States, 30506
        • Longstreet Clinic
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Wesley Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Surgical Care Associates
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Lafayette General
      • Opelousas, Louisiana, United States, 70570
        • Opelousas General
    • Michigan
      • Bay City, Michigan, United States, 48708
        • McLaren Bay Heart and Vascular
      • Farmington Hills, Michigan, United States, 48334
        • Millenium Cardiology
      • Grand Blanc, Michigan, United States, 48439
        • Ascension Genesys Hospital
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Health
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri
      • Lee's Summit, Missouri, United States, 64086
        • Saint Luke's Hospital of Kansas City
      • St Louis, Missouri, United States, 63130
        • Washington University at St. Louis
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack Meridian
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Buffalo, New York, United States, 14203
        • SUNY, The University at Buffalo
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • Staten Island, New York, United States, 10305
        • Northwell Health
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Fairfield, Ohio, United States, 45251
        • Mercy Health - The Heart Institute
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Oklahoma Heart Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Health Network Research Institute
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Prisma Health - Upstate
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Methodist Healthcare Foundation
    • Texas
      • Houston, Texas, United States, 77004
        • Houston Healthcare Medical Center
      • Houston, Texas, United States, 77030
        • University of Texas Health Sciences Center - Houston
    • Virginia
      • Norfolk, Virginia, United States, 23452
        • Sentara Vascular Specialists
    • Washington
      • Spokane, Washington, United States, 99204
        • Providence Sacred Heart
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gunderson Health
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with proximal lower extremity DVT.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary Analysis Population
Patients with unilateral acute or subacute DVT of less than or equal to 6 weeks' duration without recent (≤ 3 month) history of venous intervention.
Device: ClotTriever
Thrombectomy
Full Analysis Population
Subjects with proximal lower extremity DVT involving the femoral, common, femoral, iliac veins or inferior vena cava (IVC), alone or in combination.
Device: ClotTriever
Thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint: Proportion Participants With Major Adverse Events
Time Frame: 30 days

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)
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint (Primary Effectiveness Cohort): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus
Time Frame: Index Procedure (approximately 0.5 hours on day 0)
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.
Index Procedure (approximately 0.5 hours on day 0)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint (Full Analysis Population): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus
Time Frame: Index Procedure (approximately 0.5 hours on day 0)
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.
Index Procedure (approximately 0.5 hours on day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inari Medical

Investigators

  • Principal Investigator: Robert Beasley, MD, Icahn School Of Medicine At Mount Sinai
  • Principal Investigator: David Dexter, MD, Sentara Vascular Specialists

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

March 25, 2022

Study Completion (Actual)

July 2, 2024

Study Registration Dates

First Submitted

June 21, 2018

First Submitted That Met QC Criteria

June 29, 2018

First Posted (Actual)

July 2, 2018

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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