DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
NCT ID: NCT05701917
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
300 participants
INTERVENTIONAL
2023-01-06
2027-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Retrospective Analysis for the ClotTriever Catheter to Investigate Safety and Effectiveness in the Treatment of Acute and Subacute Iliofemoral Deep Vein Thrombosis (DVT)
NCT05740410
Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)
NCT00067093
A Study to Learn More About How Well BAY3018250 Works and How Safe it is for People With Proximal Deep Vein Thrombosis
NCT06149520
Venous Thrombectomy/Thrombolysis Outcome Registry
NCT02113475
Calf Deep Vein Thrombosis Treatment Trial
NCT03590743
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Interventional
Interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm).
ClotTriever System
Mechanical thrombectomy
Conservative Medical Management
Conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm).
Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
Anticoagulants are a group of medications that decrease your blood's ability to clot.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ClotTriever System
Mechanical thrombectomy
Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
Anticoagulants are a group of medications that decrease your blood's ability to clot.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Proximal lower extremity unilateral DVT involving at least the common femoral, external iliac, or common iliac veins, alone or in combination
* Symptom onset within 12 weeks of enrollment in the study
* Significant symptoms, as defined by a Villalta score \> 9
* 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 enrollment
* Limb-threatening circulatory compromise (e.g., phlegmasia)
* Clot in transit including IVC thrombus presenting as extension of \>2cm into the IVC from the CIV
* Symptomatic PE with right heart strain where the physician judges that a DVT intervention is inappropriate at this time.
* Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement
* Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
* Severe allergy to iodinated contrast agents that cannot be mitigated
* Hemoglobin \< 8.0 g/dL, INR \> 1.7 before warfarin was started, or platelets \< 50,000/µl which cannot be corrected prior to enrollment
* Severe renal impairment (estimated GFR \< 30 ml/min) in patients who are not yet on dialysis
* Inability to provide therapeutic anticoagulation per Investigator discretion
* Uncontrolled severe hypertension on repeated readings (systolic \> 180mmHg or diastolic \> 105mmHg)
* Recently (\< 30 days) had DVT interventional procedure
* Subject is participating in another study that may interfere with this study
* Life expectancy \< 6 months or chronic non-ambulatory status
* Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period
* Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject (e.g., contraindication to use of ClotTriever per local approved labeling, compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments)
* Subject has previously completed or withdrawn from this study
* Patient unwilling or unable to conduct the follow up visits per protocol
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Inari Medical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steven Abramowitz, MD
Role: PRINCIPAL_INVESTIGATOR
MedStar Health Research Institution
Xhorlina Marko, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health
Stephen Black, MD
Role: PRINCIPAL_INVESTIGATOR
St Thomas' Hospital (UK)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Honor Health
Scottsdale, Arizona, United States
Pima Heart and Vascular
Tucson, Arizona, United States
UCI Medical Center
Orange, California, United States
Vascular and Interventional Specialists of Orange County
Orange, California, United States
University Of Colorado
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
Baptist Health Research Institute
Jacksonville, Florida, United States
Lakeland Vascular Institute
Lakeland, Florida, United States
HCA Florida Largo Hospital
Largo, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
BayCare Health System
Tampa, Florida, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Community Healthcare System
Munster, Indiana, United States
St. Elizabeth Edgewood
Edgewood, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
McLaren Healthcare
Bay City, Michigan, United States
Henry Ford Health
Detroit, Michigan, United States
MyMichigan Medical Center
Midland, Michigan, United States
University of Missouri
Columbia, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
St. Louis University
St Louis, Missouri, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Cooper University Hospital
Camden, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Northwell Health
Bay Shore, New York, United States
NYP-Brooklyn Methodist
Brooklyn, 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
Mission Health
Asheville, North Carolina, United States
Mercy Health - The Heart Institute
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Saint Francis Hospital
Tulsa, Oklahoma, United States
Allegheny St. Vincent Hospital
Erie, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Allegheny General Health Research Network
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Prisma Health Upstate
Greenville, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Lexington Medical Center
West Columbia, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Clements University Hospital (UTSW)
Dallas, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Providence Sacred Heart Med Center
Spokane, Washington, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Vienna General Hospital (AKH Wien)
Vienna, , Austria
Helsinki University Hospital
Helsinki, , Finland
Universitätsklinikum Tübingen
Tübingen, Baden-Würtemberg, Germany
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt am Main, Hesse, Germany
Klinikum Hochsauerland GmbH
Arnsberg, North Rhine-Westphalia, Germany
Universität Leipzig
Leipzig, Saxony, Germany
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
Universitätsklinikum Augsburg
Augsburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Kantonsspital Baden
Baden, , Switzerland
Inselspital, Universitätsspital Bern
Bern, , Switzerland
Luzerner Kantonsspital
Lucerne, , Switzerland
GSST London/St Thomas
London, , United Kingdom
Imperial College
London, , United Kingdom
Freeman Hospital Newcastle upon Tyne
Newcastle upon Tyne, , United Kingdom
Oxford - John Radcliffe
Oxford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Venkataramanan Gangadharan, MD
Role: primary
Joseph Sabat, MD
Role: primary
Anthony H Chau, MD
Role: primary
Theodore Bryan, MD
Role: primary
Jonathan D Lindquist, MD
Role: primary
Hamid R Mojibian, MD
Role: primary
Saher S Sabri, MD
Role: primary
Bharat Gummadi, MD
Role: primary
Jesse Klein, DO
Role: primary
Juan C Camacho-Vasquez, MD
Role: primary
Nicholas Turman, MD
Role: primary
Alexander H Hou, MD
Role: primary
Khanjan Nagarsheth, MD
Role: primary
Nicolas Mouawad, MD
Role: primary
Scott Kaatz, MD
Role: primary
Contantinos Constantinou, MD
Role: primary
Ambarish Bhat, MD
Role: primary
Keith Pereira, MD
Role: primary
Ryan Rimer, MD
Role: primary
Laurel Hastings, MD
Role: primary
Jonathan A Schor, MD
Role: primary
Rajesh K Malik, MD
Role: primary
Katherine Teter, MD
Role: primary
Edvard Skripochnik, MD
Role: primary
Aravinda Nanjundappa, MD
Role: primary
Tucker J Harrison, DO
Role: primary
Orestis Pappas, MD
Role: primary
Robert W Ford, MD
Role: primary
Abdullah A Shaikh, MD
Role: primary
John Lee, MD
Role: primary
Brian J Brown, MD
Role: primary
Mark D Iafrati, MD
Role: primary
Michael C Siah, MD
Role: primary
David J Dexter, MD
Role: primary
Douglas A Murrey Jr., MD
Role: primary
Oliver Schlager, Dr. med
Role: primary
Matti Laine, MD, PhD
Role: primary
Gerd Grözinger, Dr. med.
Role: primary
Michael Piorkowski, Dr. med.
Role: primary
Michael Lichtenberg, MD
Role: primary
Andrej Schmidt, Prof Dr med
Role: primary
Christian Scheurig-Münkler, PD Dr.
Role: primary
Christian Erbel, Prof. Dr.
Role: primary
Michael Kostrzewa, Dr.
Role: primary
Marc Schindewolf, Dr. med.
Role: primary
Thorsten Grumann, Dr. med.
Role: primary
Taha Khan, Mr
Role: primary
Alun H Davies, Prof.
Role: primary
Sandip Nandhra, Dr.
Role: primary
Andrew Wigham, Dr
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Abramowitz SD, Marko X, D'Souza D, Noor S, Pereira K, Silver MJ, Rosenberg SP, Markovitz CD, Tu T, Weinberg I, Black S. Rationale and design of the DEFIANCE study: A randomized controlled trial of mechanical thrombectomy versus anticoagulation alone for iliofemoral deep vein thrombosis. Am Heart J. 2025 Mar;281:92-102. doi: 10.1016/j.ahj.2024.10.016. Epub 2024 Nov 3.
Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.