- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03575364
ClotTriever Outcomes (CLOUT) Registry (CLOUT)
March 20, 2024 updated by: Inari Medical
Evaluate real world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity deep vein thrombosis (DVT) with the ClotTriever Thrombectomy System.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35235
- St. Vincent's East
-
Birmingham, Alabama, United States, 35243
- Affinity Cardiovascular Specialists
-
-
California
-
Los Angeles, California, United States, 90024
- University of California, Los Angeles
-
Orange, California, United States, 92868
- Vascular and Interventional Specialists of Orange County
-
-
Colorado
-
Denver, Colorado, United States, 80045
- University of Colorado, Denver
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Yale University
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- MedStar Health Research Institution
-
-
Florida
-
Bradenton, Florida, United States, 34208
- Manatee Memorial Hospital
-
Jacksonville, Florida, United States, 32216
- Memorial Hospital Jacksonville
-
Lakeland, Florida, United States, 33801
- Lakeland Vascular Institute
-
Miami Beach, Florida, United States, 33140
- Mount Sinai Medical Center of Florida
-
Tampa, Florida, United States, 33613
- AdventHealth Tampa
-
-
Georgia
-
Gainesville, Georgia, United States, 30506
- Longstreet Clinic
-
-
Kansas
-
Wichita, Kansas, United States, 67214
- Wesley Medical Center
-
-
Kentucky
-
Louisville, Kentucky, United States, 40207
- Surgical Care Associates
-
-
Louisiana
-
Lafayette, Louisiana, United States, 70503
- Lafayette General
-
Opelousas, Louisiana, United States, 70570
- Opelousas General
-
-
Michigan
-
Bay City, Michigan, United States, 48708
- McLaren Bay Heart and Vascular
-
Farmington Hills, Michigan, United States, 48334
- Millenium Cardiology
-
Grand Blanc, Michigan, United States, 48439
- Ascension Genesys Hospital
-
Royal Oak, Michigan, United States, 48073
- Beaumont Health
-
-
Missouri
-
Columbia, Missouri, United States, 65212
- University of Missouri
-
Lee's Summit, Missouri, United States, 64086
- Saint Luke's Hospital of Kansas City
-
Saint Louis, Missouri, United States, 63130
- Washington University at St. Louis
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Hackensack Meridian
-
-
New York
-
Albany, New York, United States, 12208
- Albany Medical College
-
Buffalo, New York, United States, 14203
- SUNY, The University at Buffalo
-
New York, New York, United States, 10032
- Columbia University Irving Medical Center
-
New York, New York, United States, 10016
- NYU Langone Medical Center
-
Staten Island, New York, United States, 10305
- Northwell Health
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- The Christ Hospital
-
Fairfield, Ohio, United States, 45251
- Mercy Health - The Heart Institute
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74133
- Oklahoma Heart Institute
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson
-
Pittsburgh, Pennsylvania, United States, 15212
- Allegheny Health Network Research Institute
-
-
South Carolina
-
Greenville, South Carolina, United States, 29615
- Prisma Health - Upstate
-
-
Tennessee
-
Germantown, Tennessee, United States, 38138
- Methodist Healthcare Foundation
-
-
Texas
-
Houston, Texas, United States, 77004
- Houston Healthcare Medical Center
-
Houston, Texas, United States, 77030
- University of Texas Health Sciences Center - Houston
-
-
Virginia
-
Norfolk, Virginia, United States, 23452
- Sentara Vascular Specialists
-
-
Washington
-
Spokane, Washington, United States, 99204
- Providence Sacred Heart
-
-
Wisconsin
-
La Crosse, Wisconsin, United States, 54601
- Gunderson Health
-
Milwaukee, Wisconsin, United States, 53215
- Aurora St. Luke's Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with proximal lower extremity DVT.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Primary Analytic
Patients with unilateral acute or subacute DVT of less than 6 weeks' duration.
|
Thrombectomy
|
Registry
Patients with proximal lower extremity DVT.
|
Thrombectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite of Major Adverse Events (MAEs)
Time Frame: 30 days
|
All-cause mortality, major bleeding, symptomatic PE, or rethrombosis of target venous segment
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical Success
Time Frame: Index procedure
|
Complete or near complete (75% or greater) removal of venous thrombus from the target venous segment
|
Index procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Actual)
March 25, 2022
Study Completion (Estimated)
March 31, 2024
Study Registration Dates
First Submitted
June 21, 2018
First Submitted That Met QC Criteria
June 29, 2018
First Posted (Actual)
July 2, 2018
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on DVT
-
Bayside HealthUnknown
-
Philips Clinical & Medical Affairs GlobalRecruitingCAD | PAD | DVTUnited States
-
Tel-Aviv Sourasky Medical CenterUnknownVentilated Patients | DVT Prevention
-
University of California, Los AngelesCompletedPregnancy Related | Antepartum DVTUnited States
-
New York Institute of TechnologyTerminatedSedentary Behavior | Compression; Vein | Compression; Artery | DVT of LegsUnited States
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompletedPulmonary Embolism | Isolated Distal DVT | Proximal DVTItaly
-
University Health Network, TorontoCompleted
-
Penumbra Inc.RecruitingDeep Vein Thrombosis | DVTUnited States
-
Ottawa Hospital Research InstituteCompletedOsteoarthritis | DVTCanada
Clinical Trials on ClotTriever
-
Klinikum ArnsbergCompleted
-
Inari MedicalRecruitingVenous Thromboembolism | Deep Venous Thrombosis | Post-Thrombotic SyndromeUnited States, Germany, Switzerland