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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 : July 18, 2018
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

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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
Estimated Study Start Date : August 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

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Ages Eligible for Study:   18 Years to 75 Years   (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
  • Poor inflow to the treated segments
  • IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins
  • Diagnosed or suspected PE with hemodynamic instability any time within 3 months of the planned index procedure
  • PE signs or symptoms within 3 months of the planned index procedure without CTPA assessment performed within 7 days 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
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United States, Florida
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, North Carolina
UNC Heart & Vascular
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
Inari Medical

Additional Information:

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Responsible Party: Inari Medical
ClinicalTrials.gov Identifier: NCT03575364     History of Changes
Other Study ID Numbers: 18-001
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases