ClotTriever Outcomes (CLOUT) Registry

DVT Clinical Trial

— CLOUT  

Official title:

ClotTriever Outcomes (CLOUT) Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03575364
• Other study ID #: 18-001
• Status: Active, not recruiting
• Start date: September 1, 2018
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2024
• Source: Inari Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: March 31, 2024
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute DVT of Lower Extremity
• Chronic DVT of Lower Extremity
• Deep Vein Thrombosis Leg
• DVT
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• ClotTriever
Thrombectomy

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	McLaren Bay Heart and Vascular	Bay City	Michigan
United States	Affinity Cardiovascular Specialists	Birmingham	Alabama
United States	St. Vincent's East	Birmingham	Alabama
United States	Manatee Memorial Hospital	Bradenton	Florida
United States	SUNY, The University at Buffalo	Buffalo	New York
United States	The Christ Hospital	Cincinnati	Ohio
United States	University of Missouri	Columbia	Missouri
United States	University of Colorado, Denver	Denver	Colorado
United States	Mercy Health - The Heart Institute	Fairfield	Ohio
United States	Millenium Cardiology	Farmington Hills	Michigan
United States	Longstreet Clinic	Gainesville	Georgia
United States	Methodist Healthcare Foundation	Germantown	Tennessee
United States	Ascension Genesys Hospital	Grand Blanc	Michigan
United States	Prisma Health - Upstate	Greenville	South Carolina
United States	Hackensack Meridian	Hackensack	New Jersey
United States	Houston Healthcare Medical Center	Houston	Texas
United States	University of Texas Health Sciences Center - Houston	Houston	Texas
United States	Memorial Hospital Jacksonville	Jacksonville	Florida
United States	Gunderson Health	La Crosse	Wisconsin
United States	Lafayette General	Lafayette	Louisiana
United States	Lakeland Vascular Institute	Lakeland	Florida
United States	Saint Luke's Hospital of Kansas City	Lee's Summit	Missouri
United States	University of California, Los Angeles	Los Angeles	California
United States	Surgical Care Associates	Louisville	Kentucky
United States	Mount Sinai Medical Center of Florida	Miami Beach	Florida
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Yale University	New Haven	Connecticut
United States	Columbia University Irving Medical Center	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Sentara Vascular Specialists	Norfolk	Virginia
United States	Opelousas General	Opelousas	Louisiana
United States	Vascular and Interventional Specialists of Orange County	Orange	California
United States	Thomas Jefferson	Philadelphia	Pennsylvania
United States	Allegheny Health Network Research Institute	Pittsburgh	Pennsylvania
United States	Beaumont Health	Royal Oak	Michigan
United States	Washington University at St. Louis	Saint Louis	Missouri
United States	Providence Sacred Heart	Spokane	Washington
United States	Northwell Health	Staten Island	New York
United States	AdventHealth Tampa	Tampa	Florida
United States	Oklahoma Heart Institute	Tulsa	Oklahoma
United States	MedStar Health Research Institution	Washington	District of Columbia
United States	Wesley Medical Center	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Inari Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Major Adverse Events (MAEs)	All-cause mortality, major bleeding, symptomatic PE, or rethrombosis of target venous segment	30 days
Secondary	Technical Success	Complete or near complete (75% or greater) removal of venous thrombus from the target venous segment	Index procedure

External Links

•   Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry.
•   Mechanical Thrombectomy vs. Pharmacomechanical Catheter Directed Thrombolysis for the Treatment of Iliofemoral Deep Vein Thrombosis: A Propensity Score Matched Exploratory Analysis of 12 Month Clinical Outcomes
•   Outcomes from the ClotTriever Outcomes Registry show symptom duration may underestimate deep vein thrombus chronicity.
•   Safety and Effectiveness of Mechanical Thrombectomy From the Fully Enrolled Multicenter, Prospective CLOUT Registry.
•   Six-Month Deep Vein Thrombosis Outcomes by Chronicity: Analysis of the Real-World ClotTriever Outcomes Registry.
•   Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis from the 500-Patient CLOUT Registry.