ClotTriever Outcomes (CLOUT) Registry
- Conditions
- DVTChronic DVT of Lower ExtremityAcute DVT of Lower ExtremityDeep Vein Thrombosis Leg
- Interventions
- Device: ClotTriever
- Registration Number
- NCT03575364
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Primary Analytic ClotTriever Patients with unilateral acute or subacute DVT of less than 6 weeks' duration. Registry ClotTriever Patients with proximal lower extremity DVT.
- Primary Outcome Measures
Name Time Method Composite of Major Adverse Events (MAEs) 30 days All-cause mortality, major bleeding, symptomatic PE, or rethrombosis of target venous segment
- Secondary Outcome Measures
Name Time Method Technical Success Index procedure Complete or near complete (75% or greater) removal of venous thrombus from the target venous segment
Trial Locations
- Locations (43)
Allegheny Health Network Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
MedStar Health Research Institution
🇺🇸Washington, District of Columbia, United States
Mount Sinai Medical Center of Florida
🇺🇸Miami Beach, Florida, United States
Beaumont Health
🇺🇸Royal Oak, Michigan, United States
McLaren Bay Heart and Vascular
🇺🇸Bay City, Michigan, United States
Millenium Cardiology
🇺🇸Farmington Hills, Michigan, United States
Lafayette General
🇺🇸Lafayette, Louisiana, United States
University of Missouri
🇺🇸Columbia, Missouri, United States
Washington University at St. Louis
🇺🇸Saint Louis, Missouri, United States
Saint Luke's Hospital of Kansas City
🇺🇸Lee's Summit, Missouri, United States
Hackensack Meridian
🇺🇸Hackensack, New Jersey, United States
Albany Medical College
🇺🇸Albany, New York, United States
Houston Healthcare Medical Center
🇺🇸Houston, Texas, United States
University of Texas Health Sciences Center - Houston
🇺🇸Houston, Texas, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Vascular and Interventional Specialists of Orange County
🇺🇸Orange, California, United States
Longstreet Clinic
🇺🇸Gainesville, Georgia, United States
SUNY, The University at Buffalo
🇺🇸Buffalo, New York, United States
Northwell Health
🇺🇸Staten Island, New York, United States
Thomas Jefferson
🇺🇸Philadelphia, Pennsylvania, United States
Sentara Vascular Specialists
🇺🇸Norfolk, Virginia, United States
Providence Sacred Heart
🇺🇸Spokane, Washington, United States
Mercy Health - The Heart Institute
🇺🇸Fairfield, Ohio, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
St. Vincent's East
🇺🇸Birmingham, Alabama, United States
Affinity Cardiovascular Specialists
🇺🇸Birmingham, Alabama, United States
AdventHealth Tampa
🇺🇸Tampa, Florida, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
University of Colorado, Denver
🇺🇸Denver, Colorado, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Manatee Memorial Hospital
🇺🇸Bradenton, Florida, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Surgical Care Associates
🇺🇸Louisville, Kentucky, United States
Memorial Hospital Jacksonville
🇺🇸Jacksonville, Florida, United States
Lakeland Vascular Institute
🇺🇸Lakeland, Florida, United States
Gunderson Health
🇺🇸La Crosse, Wisconsin, United States
Opelousas General
🇺🇸Opelousas, Louisiana, United States
Ascension Genesys Hospital
🇺🇸Grand Blanc, Michigan, United States
Methodist Healthcare Foundation
🇺🇸Germantown, Tennessee, United States
Prisma Health - Upstate
🇺🇸Greenville, South Carolina, United States