Study Results
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View full resultsBasic Information
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COMPLETED
499 participants
OBSERVATIONAL
2018-09-01
2024-07-02
Brief Summary
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Retrospective Analysis for the ClotTriever Catheter to Investigate Safety and Effectiveness in the Treatment of Acute and Subacute Iliofemoral Deep Vein Thrombosis (DVT)
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
ClotTriever
Thrombectomy
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.
ClotTriever
Thrombectomy
Interventions
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ClotTriever
Thrombectomy
Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide informed consent.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Inari Medical
INDUSTRY
Responsible Party
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Principal Investigators
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David Dexter, MD
Role: PRINCIPAL_INVESTIGATOR
Sentara Vascular Specialists
Robert Beasley, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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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
Albany Medical College
Albany, New York, United States
SUNY, The University at Buffalo
Buffalo, New York, United States
NYU Langone Medical Center
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Northwell Health
Staten Island, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
Mercy Health - The Heart Institute
Fairfield, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Thomas Jefferson
Philadelphia, Pennsylvania, United States
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, United States
Prisma Health - Upstate
Greenville, South Carolina, United States
Methodist Healthcare Foundation
Germantown, Tennessee, United States
Houston Healthcare Medical Center
Houston, Texas, United States
University of Texas Health Sciences Center - Houston
Houston, Texas, United States
Sentara Vascular Specialists
Norfolk, Virginia, United States
Providence Sacred Heart
Spokane, Washington, United States
Gunderson Health
La Crosse, Wisconsin, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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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
Other Identifiers
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18-001
Identifier Type: -
Identifier Source: org_study_id
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