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Completed

NCT Number: NCT03575364

ClotTriever Outcomes (CLOUT) Registry

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

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Key information

Conditions

Deep Vein Thrombosis Leg Acute DVT of Lower Extremity Cardiovascular Diseases Chronic DVT of Lower Extremity DVT Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Affinity Cardiovascular Specialists, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ClotTriever

Device

Thrombectomy

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Inari Medical

Industry

Registry information

Acronym: CLOUT

Important dates

Study start
2018
Primary completion
2022
Study completion
2024
First posted
Jul 2, 2018
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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