ClotTriever Outcomes (CLOUT) Registry (CLOUT)

• ClinicalTrials.gov Identifier: NCT03575364
• Recruitment Status: Active, not recruiting
• First Posted: July 2, 2018
• Last Update Posted: March 22, 2024
• Sponsor: Inari Medical
• 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: March 22, 2024
• Actual Study Start Date: September 1, 2018
• Actual Primary Completion Date: March 25, 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

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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 29, 2018): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2024
• Actual Primary Completion Date: March 25, 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

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

• Current Responsible Party: Inari Medical
• Original Responsible Party: Same as current
• Current Study Sponsor: Inari Medical
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Inari Medical
• Verification Date: March 2024