ClotTriever Outcomes (CLOUT) Registry

Completed

Conditions studied: Deep Vein Thrombosis Leg, DVT, Chronic DVT of Lower Extremity, Acute DVT of Lower Extremity

In brief

Evaluate real world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity deep vein thrombosis (DVT) with the ClotTriever Thrombectomy System.

Key facts

Study ID

NCT03575364

Run by

Inari Medical

People needed

499

Starts

2018-09-01

Expected to finish

2024-07-02

Last updated by the study team

2025-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• St. Vincent's East — Birmingham, Alabama, United States
• Affinity Cardiovascular Specialists — Birmingham, Alabama, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Vascular and Interventional Specialists of Orange County — Orange, California, United States
• University of Colorado, Denver — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• MedStar Health Research Institution — Washington D.C., District of Columbia, United States
• Manatee Memorial Hospital — Bradenton, Florida, United States
• Memorial Hospital Jacksonville — Jacksonville, Florida, United States
• Lakeland Vascular Institute — Lakeland, Florida, United States
• Mount Sinai Medical Center of Florida — Miami Beach, Florida, United States
• AdventHealth Tampa — Tampa, Florida, United States
• Longstreet Clinic — Gainesville, Georgia, United States
• Wesley Medical Center — Wichita, Kansas, United States
• Surgical Care Associates — Louisville, Kentucky, United States
• Lafayette General — Lafayette, Louisiana, United States
• Opelousas General — Opelousas, Louisiana, United States
• McLaren Bay Heart and Vascular — Bay City, Michigan, United States
• Millenium Cardiology — Farmington Hills, Michigan, United States
• Ascension Genesys Hospital — Grand Blanc, Michigan, United States
• Beaumont Health — Royal Oak, Michigan, United States
• University of Missouri — Columbia, Missouri, United States
• Saint Luke's Hospital of Kansas City — Lee's Summit, Missouri, United States
• Washington University at St. Louis — St Louis, Missouri, United States
• Hackensack Meridian — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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