ClotTriever Outcomes (CLOUT) Registry

NCT03575364 | Completed Results

• 1 other identifier: 18-001
• Study Type: observational
• Target: 499
• Locations: 1 country
• Sites: 43

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.

Conditions

Deep Vein Thrombosis Leg; DVT; Chronic DVT of Lower Extremity; Acute DVT of Lower Extremity

Keywords

ClotTriever; Thrombectomy

Outcome Measures

Primary Outcomes (1)

• Primary Safety Endpoint: Proportion Participants With Major Adverse Events

  The primary safety endpoint is the proportion of participants with Major Adverse Events (MAE). MAEs are defined as a composite endpoint triggered when any of four categories of events occurred through 30 days after the index procedure, as observed in the Primary Safety Cohort (the composite endpoints were not observed for the Full Analysis Population: * All-cause mortality * Major bleeding * New symptomatic pulmonary embolism (PE) documented by computed tomography pulmonary angiography (CTPA) * Rethrombosis of a target vessel segment (TVS)

  30 days

Secondary Outcomes (1)

• Primary Effectiveness Endpoint (Primary Effectiveness Cohort): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus

  Index Procedure (approximately 0.5 hours on day 0)

Other Outcomes (1)

• Primary Effectiveness Endpoint (Full Analysis Population): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus

  Index Procedure (approximately 0.5 hours on day 0)

Study Arms (2)

Primary Analysis Population

Patients with unilateral acute or subacute DVT of less than or equal to 6 weeks' duration without recent (≤ 3 month) history of venous intervention.

Device: ClotTriever

Full Analysis Population

Subjects with proximal lower extremity DVT involving the femoral, common, femoral, iliac veins or inferior vena cava (IVC), alone or in combination.

Device: ClotTriever

Interventions

ClotTriever DEVICE

Thrombectomy

Full Analysis Population; Primary Analysis Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with proximal lower extremity DVT.

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

Sponsors & Collaborators

• Inari Medical: lead

Study Sites (43)

St. Vincent's East

Birmingham, Alabama, 35235, United States

Location

Affinity Cardiovascular Specialists

Birmingham, Alabama, 35243, United States

Location

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

Vascular and Interventional Specialists of Orange County

Orange, California, 92868, United States

Location

University of Colorado, Denver

Denver, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

MedStar Health Research Institution

Washington D.C., District of Columbia, 20010, United States

Location

Manatee Memorial Hospital

Bradenton, Florida, 34208, United States

Location

Memorial Hospital Jacksonville

Jacksonville, Florida, 32216, United States

Location

Lakeland Vascular Institute

Lakeland, Florida, 33801, United States

Location

Mount Sinai Medical Center of Florida

Miami Beach, Florida, 33140, United States

Location

AdventHealth Tampa

Tampa, Florida, 33613, United States

Location

Longstreet Clinic

Gainesville, Georgia, 30506, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Surgical Care Associates

Louisville, Kentucky, 40207, United States

Location

Lafayette General

Lafayette, Louisiana, 70503, United States

Location

Opelousas General

Opelousas, Louisiana, 70570, United States

Location

McLaren Bay Heart and Vascular

Bay City, Michigan, 48708, United States

Location

Millenium Cardiology

Farmington Hills, Michigan, 48334, United States

Location

Ascension Genesys Hospital

Grand Blanc, Michigan, 48439, United States

Location

Beaumont Health

Royal Oak, Michigan, 48073, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Saint Luke's Hospital of Kansas City

Lee's Summit, Missouri, 64086, United States

Location

Washington University at St. Louis

St Louis, Missouri, 63130, United States

Location

Hackensack Meridian

Hackensack, New Jersey, 07601, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

SUNY, The University at Buffalo

Buffalo, New York, 14203, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Northwell Health

Staten Island, New York, 10305, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Mercy Health - The Heart Institute

Fairfield, Ohio, 45251, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74133, United States

Location

Thomas Jefferson

Philadelphia, Pennsylvania, 19107, United States

Location

Allegheny Health Network Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

Prisma Health - Upstate

Greenville, South Carolina, 29615, United States

Location

Methodist Healthcare Foundation

Germantown, Tennessee, 38138, United States

Location

Houston Healthcare Medical Center

Houston, Texas, 77004, United States

Location

University of Texas Health Sciences Center - Houston

Houston, Texas, 77030, United States

Location

Sentara Vascular Specialists

Norfolk, Virginia, 23452, United States

Location

Providence Sacred Heart

Spokane, Washington, 99204, United States

Location

Gunderson Health

La Crosse, Wisconsin, 54601, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (9)

• Dexter DJ, Kado H, Schor J, Annambhotla S, Olivieri B, Mojibian H, Maldonado TS, Gandhi S, Paulisin J, Bunte MC, Angel W, Roberts J, Veerina K, Abramowitz S, Elmasri F, Hnath J, Jung M, Long D, Sanchez L, Cosme O, Skripochnik E, Lodha A, Shaikh A, King C, Bisharat M, Beasley RE; CLOUT Investigators. Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry. J Vasc Surg Venous Lymphat Disord. 2022 Jul;10(4):832-840.e2. doi: 10.1016/j.jvsv.2022.02.013. Epub 2022 Feb 24.

  PMID: 35218955 BACKGROUND

• Maldonado TS, Dexter DJ, Kado H, Schor J, Annambhotla S, Mojibian H, Beasley RE; CLOUT Registry Investigators. Outcomes from the ClotTriever Outcomes Registry show symptom duration may underestimate deep vein thrombus chronicity. J Vasc Surg Venous Lymphat Disord. 2022 Nov;10(6):1251-1259. doi: 10.1016/j.jvsv.2022.04.015. Epub 2022 Jun 14.

  PMID: 35714903 BACKGROUND

• Dexter D, Kado H, Shaikh A, Schor J, Annambhotla S, Zybulewski A, Paulisin J, Bisharat M, Mouawad NJ, Bunte MC, Maldonado T, Skripochnik E, Raskin A, Gandhi S, Ichinose E, Beasley R, Mojibian H. Safety and Effectiveness of Mechanical Thrombectomy From the Fully Enrolled Multicenter, Prospective CLOUT Registry. J Soc Cardiovasc Angiogr Interv. 2023 Feb 23;2(2):100585. doi: 10.1016/j.jscai.2023.100585. eCollection 2023 Mar-Apr.

  PMID: 39129803 BACKGROUND

• Abramowitz SD, Kado H, Schor J, Annambhotla S, Mojibian H, Marino AG, Maldonado TS, Gandhi S, Paulisin J, Bunte MC, Angel W, Roberts J, Veerina K, Long D, Elmasri F, Shaikh A, Beasley RE, Dexter D; CLOUT Investigators. Six-Month Deep Vein Thrombosis Outcomes by Chronicity: Analysis of the Real-World ClotTriever Outcomes Registry. J Vasc Interv Radiol. 2023 May;34(5):879-887.e4. doi: 10.1016/j.jvir.2022.12.480.

  PMID: 37105663 BACKGROUND

• Shaikh A, Zybulewski A, Paulisin J, Bisharat M, Mouawad NJ, Raskin A, Ichinose E, Abramowitz S, Lindquist J, Azene E, Shah N, Nguyen J, Cockrell J, Khalsa B, Khetarpaul V, Murrey DA Jr, Veerina K, Skripochnik E, Maldonado TS, Bunte MC, Annambhotla S, Schor J, Kado H, Mojibian H, Dexter D; CLOUT Investigators. Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis from the 500-Patient CLOUT Registry. Cardiovasc Intervent Radiol. 2023 Nov;46(11):1571-1580. doi: 10.1007/s00270-023-03509-8. Epub 2023 Aug 14.

  PMID: 37580422 BACKGROUND

• Abramowitz S, Marko X, Willis VC, Mills C, Black SA. Association Between 30 Day Villalta Scores and Long Term Post-Thrombotic Syndrome Incidence and Severity Following Acute Deep Vein Thrombosis. Eur J Vasc Endovasc Surg. 2024 Jan;67(1):167-168. doi: 10.1016/j.ejvs.2023.09.045. Epub 2023 Oct 5. No abstract available.

  PMID: 37802419 BACKGROUND

• Bisharat MB, Ichinose EJ, Veerina KK, Khetarpaul V, Azene EM, Plotnik AN, Hnath J, Trestman E, Harlin SA, Bhat A, Li S, Long GW, O'Connor D, Winokur RS, Zia S, Dexter DJ. One-Year Clinical Outcomes Following Mechanical Thrombectomy for Deep Vein Thrombosis: A CLOUT Registry Analysis. J Soc Cardiovasc Angiogr Interv. 2024 Feb 15;3(3Part A):101307. doi: 10.1016/j.jscai.2024.101307. eCollection 2024 Mar.

  PMID: 39131784 BACKGROUND

• Abramowitz S, Bunte MC, Maldonado TS, Skripochnik E, Gandhi S, Mouawad NJ, Mojibian H, Schor J, Dexter DJ; CLOUT study collaborators. 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. Eur J Vasc Endovasc Surg. 2024 Apr;67(4):644-652. doi: 10.1016/j.ejvs.2023.11.017. Epub 2023 Nov 21.

  PMID: 37981003 BACKGROUND

• Abramowitz S, Shaikh A, Mojibian H, Mouawad NJ, Bunte MC, Skripochnik E, Lindquist J, Elmasri F, Khalsa B, Bhat A, Nguyen J, Shah N, Noor SS, Murrey D, Gandhi S, Raskin A, Schor J, Dexter DJ. Comparison of anticoagulation vs mechanical thrombectomy for the treatment of iliofemoral deep vein thrombosis. J Vasc Surg Venous Lymphat Disord. 2024 Jul;12(4):101825. doi: 10.1016/j.jvsv.2024.101825. Epub 2024 Jan 24.

  PMID: 38278173 BACKGROUND

Related Links

• Six-Month Deep Vein Thrombosis Outcomes by Chronicity: Analysis of the Real-World ClotTriever Outcomes Registry.
• Safety and Effectiveness of Mechanical Thrombectomy From the Fully Enrolled Multicenter, Prospective CLOUT Registry.
• Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry.
• Outcomes from the ClotTriever Outcomes Registry show symptom duration may underestimate deep vein thrombus chronicity.
• Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis from the 500-Patient 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
• Association Between 30 Day Villalta Scores and Long Term Post-Thrombotic Syndrome Incidence and Severity Following Acute Deep Vein Thrombosis
• Comparison of anticoagulation vs mechanical thrombectomy for the treatment of iliofemoral deep vein thrombosis.
• One-Year Clinical Outcomes Following Mechanical Thrombectomy for Deep Vein Thrombosis: A CLOUT Registry Analysis

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Ashleigh Willson
• Organization: Inari Medical

ashleigh.willson@inarimedical.com

925-330-3446

Study Officials

• David Dexter, MD

  Sentara Vascular Specialists

  PRINCIPAL INVESTIGATOR

• Robert Beasley, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 2, 2018
• Study Start: September 1, 2018
• Primary Completion: March 25, 2022
• Study Completion: July 2, 2024
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Locations

US (43)