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ClotTriever Outcomes (CLOUT) Registry

Key facts

Who runs it
Inari Medical
Where
Albany, Bay City, Birmingham, Bradenton, Buffalo, Cincinnati, Columbia, Denver, Fairfield, Farmington Hills, Gainesville, Germantown, Grand Blanc, Greenville, Hackensack, Houston, Jacksonville, La Crosse, Lafayette, Lakeland, Lee's Summit, Los Angeles, Louisville, Miami Beach, Milwaukee, New Haven, New York, Norfolk, Opelousas, Orange, Philadelphia, Pittsburgh, Royal Oak, Spokane, St Louis, Staten Island, Tampa, Tulsa, Washington D.C., and Wichita, United StatesSee the 43 sites
Trial code
Status
Completed
People taking part
499 people enrolled
Started
1 Sept 2018
Ended
2 Jul 2024
Type of study
Observational, 2 groups
Treatments tested
  • ClotTriever
Record updated
26 August 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior venous stent in the target venous segment
  • Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used
  • 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
  • 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

Where in United States

  • Albany Medical CollegeAlbany, United States
  • McLaren Bay Heart and VascularBay City, United States
  • Affinity Cardiovascular SpecialistsBirmingham, United States
  • St. Vincent's EastBirmingham, United States
  • Manatee Memorial HospitalBradenton, United States
  • SUNY, The University at BuffaloBuffalo, United States
  • The Christ HospitalCincinnati, United States
  • University of MissouriColumbia, United States
  • University of Colorado DenverDenver, United States
  • Mercy Health - The Heart InstituteFairfield, United States
  • Millenium CardiologyFarmington Hills, United States
  • Longstreet ClinicGainesville, United States
  • Methodist Healthcare FoundationGermantown, United States
  • Ascension Genesys HospitalGrand Blanc, United States
  • Prisma Health-UpstateGreenville, United States
  • Hackensack MeridianHackensack, United States
  • Houston Healthcare Medical CenterHouston, United States
  • University of Texas Health Sciences Center - HoustonHouston, United States
  • Memorial Hospital JacksonvilleJacksonville, United States
  • Gunderson HealthLa Crosse, United States
  • Lafayette GeneralLafayette, United States
  • Lakeland Vascular InstituteLakeland, United States
  • Saint Luke's Hospital of Kansas CityLee's Summit, United States
  • University of California, Los AngelesLos Angeles, United States
  • Surgical Care AssociatesLouisville, United States
  • Mount Sinai Medical Center of FloridaMiami Beach, United States
  • Aurora St. Luke's Medical CenterMilwaukee, United States
  • Yale UniversityNew Haven, United States
  • Columbia University Irving Medical CenterNew York, United States
  • NYU Langone Medical CenterNew York, United States
  • Sentara Vascular SpecialistsNorfolk, United States
  • Opelousas GeneralOpelousas, United States
  • Vascular and Interventional Specialists of Orange CountyOrange, United States
  • Thomas JeffersonPhiladelphia, United States
  • Allegheny Health Network Research InstitutePittsburgh, United States
  • Beaumont HealthRoyal Oak, United States
  • Providence Sacred HeartSpokane, United States
  • Washington University at St. LouisSt Louis, United States
  • Northwell HealthStaten Island, United States
  • AdventHealth TampaTampa, United States
  • Oklahoma Heart InstituteTulsa, United States
  • MedStar Health Research InstitutionWashington D.C., United States
  • Wesley Medical CenterWichita, United States

About the trial

What the trial wants to find out

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 2 groups in the trial

  • 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.

    Treatment: ClotTriever

  • 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.

    Treatment: ClotTriever

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
26 August 2025