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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

Tracking Information
First Submitted Date June 21, 2018
First Posted Date July 2, 2018
Last Update Posted Date April 19, 2021
Actual Study Start Date September 1, 2018
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 29, 2018)
Composite of Major Adverse Events (MAEs) [ Time Frame: 30 days ]
All-cause mortality, major bleeding, symptomatic PE, or rethrombosis of target venous segment
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 29, 2018)
Technical Success [ Time Frame: Index procedure ]
Complete or near complete (75% or greater) removal of venous thrombus from the target venous segment
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ClotTriever Outcomes (CLOUT) Registry
Official Title ClotTriever Outcomes (CLOUT) Registry
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with proximal lower extremity DVT.
Condition
  • Deep Vein Thrombosis Leg
  • DVT
  • Chronic DVT of Lower Extremity
  • Acute DVT of Lower Extremity
Intervention Device: ClotTriever
Thrombectomy
Study Groups/Cohorts
  • Primary Analytic
    Patients with unilateral acute or subacute DVT of less than 6 weeks' duration.
    Intervention: Device: ClotTriever
  • Registry
    Patients with proximal lower extremity DVT.
    Intervention: Device: ClotTriever
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: June 29, 2018)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2024
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03575364
Other Study ID Numbers 18-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Inari Medical
Study Sponsor Inari Medical
Collaborators Not Provided
Investigators Not Provided
PRS Account Inari Medical
Verification Date April 2021