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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

City, postcode or hospital

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

Other trials in United States

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 groups in NCT03575364
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.

1 Sep 20182 Jul 2024

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

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 35218955
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.
PubMed 35714903
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.
PubMed 39129803
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.
PubMed 37105663
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.
PubMed 37580422
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.
PubMed 37802419
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.
PubMed 39131784
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.
PubMed 37981003
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.
PubMed 38278173

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
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All Deep Vein Thrombosis Leg trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ClotTriever Outcomes (CLOUT) Registry
ClinicalTrials.gov ID: NCT03575364
Acronym / sponsor ID: CLOUT / 18-001
Conditions: Deep Vein Thrombosis Leg, DVT, Chronic DVT of Lower Extremity, Acute DVT of Lower Extremity
Keywords: ClotTriever, Thrombectomy
Study type: Observational
Recruitment status: Completed
Enrolment: 499 participants (actual)
Lead sponsor: Inari MedicalIndustry (pharma, biotech, devices)
Study start: 1 Sep 2018 (actual)
Primary completion: 25 Mar 2022 (actual)
Study completion: 2 Jul 2024 (actual)
First posted: 2 Jul 2018 (actual)
Results: Posted 26 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 2 Years
Number of arms: 2

Arm	Type	Receives
Primary Analysis Population	–	Device: ClotTrieverPatients with unilateral acute or subacute DVT of less than or equal to 6 weeks' duration without recent (≤ 3 month) history of venous intervention.
Full Analysis Population	–	Device: ClotTrieverSubjects with proximal lower extremity DVT involving the femoral, common, femoral, iliac veins or inferior vena cava (IVC), alone or in combination.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with proximal lower extremity DVT.

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ClotTrieverThrombectomy	Device	Full Analysis Population, Primary Analysis Population

Primary outcome

Primary Safety Endpoint: Proportion Participants With Major Adverse Events
Time frame: 30 days
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)

1 secondary outcome

Primary Effectiveness Endpoint (Primary Effectiveness Cohort): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus
Time frame: Index Procedure (approximately 0.5 hours on day 0)

Results and safety

Results posted to the registry on 26 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Full Analysis Population	499	285

Primary outcome: Primary Safety Endpoint: Proportion Participants With Major Adverse Events

Time frame: 30 days. Count of participants. Unit: Participants

Measure	Primary Safety Cohort n = 76
Value	15

Population analysed: The Primary Analysis Population is a subset of the Full Analysis Population, comprising the first 91 subjects with unilateral acute or subacute DVT of less than or equal to 6 weeks duration without recent (≤ 3 month) history of venous intervention. The Primary Safety Cohort are the 76 subjects in the Primary Analysis Population who had evaluable data for the primary safety endpoint.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Full Analysis Population	120 of 499 (24%)	76 of 499 (15.2%)	45 of 330

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 35218955Dexter 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.
Background: PubMed 35714903Maldonado 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.
Background: PubMed 39129803Dexter 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.
Background: PubMed 37105663Abramowitz 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.
Background: PubMed 37580422Shaikh 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.
Background: PubMed 37802419Abramowitz 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.
Background: PubMed 39131784Bisharat 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.
Background: PubMed 37981003Abramowitz 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.
Background: PubMed 38278173Abramowitz 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.
Six-Month Deep Vein Thrombosis Outcomes by Chronicity: Analysis of the Real-World ClotTriever Outcomes Registry.Link provided by the sponsor.
Safety and Effectiveness of Mechanical Thrombectomy From the Fully Enrolled Multicenter, Prospective CLOUT Registry.Link provided by the sponsor.
Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry.Link provided by the sponsor.
Outcomes from the ClotTriever Outcomes Registry show symptom duration may underestimate deep vein thrombus chronicity.Link provided by the sponsor.
Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis from the 500-Patient CLOUT Registry.Link provided by the sponsor.
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 OutcomesLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Dexter, MD principal investigator

Sentara Vascular Specialists

Robert Beasley, MD principal investigator

Icahn School of Medicine at Mount Sinai

43 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Deep Vein Thrombosis Leg and DVT, run by Inari Medical at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint: Proportion Participants With Major Adverse Events (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03575364, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.