Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

ClotTriever Outcomes (CLOUT) Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03575364
Recruitment Status : Enrolling by invitation
First Posted : July 2, 2018
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Inari Medical

Brief Summary:
Evaluate real world patient outcomes after treatment of acute and non-acute lower extremity deep vein thrombosis (DVT) with the ClotTriever Thrombectomy System.

Condition or disease Intervention/treatment
Deep Vein Thrombosis Leg DVT Chronic DVT of Lower Extremity Acute DVT of Lower Extremity Device: ClotTriever

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: ClotTriever Outcomes (CLOUT) Registry
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Group/Cohort Intervention/treatment
Primary Analytic
Patients with unilateral acute and/or chronic DVT of less than six weeks' duration.
Device: ClotTriever
Thrombectomy

Registry
Patients with iliac and/or femoral DVT
Device: ClotTriever
Thrombectomy




Primary Outcome Measures :
  1. Composite of Major Adverse Events (MAEs) [ Time Frame: 30 days ]
    All-cause mortality, major bleeding, symptomatic PE, or rethrombosis of target venous segment


Secondary Outcome Measures :
  1. Technical Success [ Time Frame: Index procedure ]
    Complete or near complete (75% or greater) removal of venous thrombus from the target venous segment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with iliac and/or femoral DVT
Criteria

Inclusion Criteria:

  • Lower extremity DVT involving the femoral, common femoral, iliac veins or inferior vena cava (IVC), alone or in combination.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575364


Locations
Layout table for location information
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
United States, Florida
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Georgia
Longstreet Clinic
Gainesville, Georgia, United States, 30506
United States, Kentucky
Baptist East
Louisville, Kentucky, United States, 40207
United States, Michigan
Millenium Cardiology
Farmington Hills, Michigan, United States, 48334
Ascension Genesys Hospital
Grand Blanc, Michigan, United States, 48439
United States, Missouri
Saint Luke's Cardiovascular Consultants
Lee's Summit, Missouri, United States, 64086
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Northwell Health/Lenox Hill
New York, New York, United States, 10075
Northwell Health/Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, Ohio
Lindner Center for Research and Education at the The Christ Hospital
Cincinnati, Ohio, United States, 45219
United States, South Carolina
Prisma Health - Upstate
Greenville, South Carolina, United States, 29615
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23452
Sponsors and Collaborators
Inari Medical
Additional Information:

Layout table for additonal information
Responsible Party: Inari Medical
ClinicalTrials.gov Identifier: NCT03575364    
Other Study ID Numbers: 18-001
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inari Medical:
ClotTriever
Thrombectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases