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ClotTriever Outcomes (CLOUT) Registry (CLOUT)

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ClinicalTrials.gov Identifier: NCT03575364
Recruitment Status : Enrolling by invitation
First Posted : July 2, 2018
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Inari Medical

Brief Summary:
Evaluate real world patient outcomes after treatment of acute, subacute, and chronic proximal 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
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2024

Group/Cohort Intervention/treatment
Primary Analytic
Patients with unilateral acute or subacute DVT of less than 6 weeks' duration.
Device: ClotTriever
Thrombectomy

Registry
Patients with proximal lower extremity 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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with proximal lower extremity DVT.
Criteria

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

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
Show Show 34 study locations
Sponsors and Collaborators
Inari Medical
Additional Information:

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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: April 19, 2021
Last Verified: April 2021
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