Deep Vein Thrombosis LegCLOUTNCT03575364
ClotTriever Outcomes (CLOUT) Registry
An observational study of Deep Vein Thrombosis Leg and DVT, run by Inari Medical at 43 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis Leg, DVT, Chronic DVT of Lower Extremity
- What is being tested?
- ClotTriever
- Type of treatment
- Medical device
- How many people
- 499 participants
- Where
- 43 sitesUnited States
- Study dates
- 1 Sep 2018to 2 Jul 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with proximal lower extremity DVT.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Albany Medical College
Albany, New York, 12208
McLaren Bay Heart and Vascular
Bay City, Michigan, 48708
St. Vincent's East
Birmingham, Alabama, 35235
Affinity Cardiovascular Specialists
Birmingham, Alabama, 35243
Manatee Memorial Hospital
Bradenton, Florida, 34208
SUNY, The University at Buffalo
Buffalo, New York, 14203
The Christ Hospital
Cincinnati, Ohio, 45219
University of Missouri
Columbia, Missouri, 65212
University of Colorado, Denver
Denver, Colorado, 80045
Mercy Health - The Heart Institute
Fairfield, Ohio, 45251
Millenium Cardiology
Farmington Hills, Michigan, 48334
Longstreet Clinic
Gainesville, Georgia, 30506
Methodist Healthcare Foundation
Germantown, Tennessee, 38138
Ascension Genesys Hospital
Grand Blanc, Michigan, 48439
Prisma Health - Upstate
Greenville, South Carolina, 29615
Hackensack Meridian
Hackensack, New Jersey, 07601
Houston Healthcare Medical Center
Houston, Texas, 77004
University of Texas Health Sciences Center - Houston
Houston, Texas, 77030
Memorial Hospital Jacksonville
Jacksonville, Florida, 32216
Gunderson Health
La Crosse, Wisconsin, 54601
Lafayette General
Lafayette, Louisiana, 70503
Lakeland Vascular Institute
Lakeland, Florida, 33801
Saint Luke's Hospital of Kansas City
Lee's Summit, Missouri, 64086
University of California, Los Angeles
Los Angeles, California, 90024
Surgical Care Associates
Louisville, Kentucky, 40207
Mount Sinai Medical Center of Florida
Miami Beach, Florida, 33140
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Yale University
New Haven, Connecticut, 06511
NYU Langone Medical Center
New York, New York, 10016
Columbia University Irving Medical Center
New York, New York, 10032
Sentara Vascular Specialists
Norfolk, Virginia, 23452
Opelousas General
Opelousas, Louisiana, 70570
Vascular and Interventional Specialists of Orange County
Orange, California, 92868
Thomas Jefferson
Philadelphia, Pennsylvania, 19107
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, 15212
Beaumont Health
Royal Oak, Michigan, 48073
Providence Sacred Heart
Spokane, Washington, 99204
Washington University at St. Louis
St Louis, Missouri, 63130
Northwell Health
Staten Island, New York, 10305
AdventHealth Tampa
Tampa, Florida, 33613
Oklahoma Heart Institute
Tulsa, Oklahoma, 74133
MedStar Health Research Institution
Washington D.C., District of Columbia, 20010
Wesley Medical Center
Wichita, Kansas, 67214
About this study
Evaluate real world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity deep vein thrombosis (DVT) with the ClotTriever Thrombectomy System.
Read the detailed description
The CLOUT Registry is a prospective, multi-center, observational registry of subjects with proximal lower extremity DVT treated with the ClotTriever Thrombectomy System. The Registry will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through 2 years of follow-up.
- Conditions
- Deep Vein Thrombosis Leg, DVT, Chronic DVT of Lower Extremity, Acute DVT of Lower Extremity
- Being tested
- ClotTriever
- Keywords
- ClotTriever, Thrombectomy
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClotTrieverDevice
Thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: ClotTriever |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days
Secondary outcomes (1)
Primary Effectiveness Endpoint (Primary Effectiveness Cohort): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus
Complete or near complete (≥75%) removal of venous thrombus from the TVS, as determined by the percent reduction in the Marder score for those segments. When more than one venous segment is treated, the change in Marder score is calculated as the total score for the treated segments prior to intervention with the study device (baseline score) minus the total score after treatment with the study device but before treatment with any adjunctive devices or pharmacologic agents (post-treatment score), divided by the baseline score.
Measured: Index Procedure (approximately 0.5 hours on day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Sep 2018
- Primary completion25 Mar 2022
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Deep Vein Thrombosis LegStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 499 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Inari Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Dexter, MD, Principal investigator, Sentara Vascular SpecialistsRobert Beasley, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575364
- Sponsor's protocol ID
- 18-001
- Acronym
- CLOUT
- Status last verified
- Aug 2025
- First submitted
- 21 Jun 2018
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35218955Maldonado 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.
PubMed 35714903Dexter 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.
PubMed 39129803Abramowitz 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.
PubMed 37105663Shaikh 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.
PubMed 37580422Abramowitz 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.
PubMed 37802419Bisharat 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.
PubMed 39131784Abramowitz 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.
PubMed 37981003Abramowitz 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.
PubMed 38278173