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Clinical Trials in the USA / NCT05701917
Recruiting Not applicable

DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis

NCT05701917 · tracked via the Priya Life Science USA tracker
Sponsor
Inari Medical
Phase
Not applicable
Started
2023-01-06
Last updated
2026-09-09

Condition(s) studied

Venous ThromboembolismDeep Venous ThrombosisPost-Thrombotic Syndrome

Investigational drug(s) / intervention(s)

ClotTriever SystemCommercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.

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.

Study summary

This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT. The study will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria * Age ≥ 18 years * 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 * Bilateral iliofemoral DVT * 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

Primary outcome measure(s)

Trial sites (64)

FacilityCityRegionStatus
Honor Health Scottsdale Arizona Recruiting
Pima Heart and Vascular Tucson Arizona Recruiting
UCI Medical Center Orange California Recruiting
Vascular and Interventional Specialists of Orange County Orange California Recruiting
Huntington Health Pasadena California Recruiting
University Of Colorado Denver Colorado Recruiting
Yale University New Haven Connecticut Recruiting
MedStar Health Research Institution Washington D.C. District of Columbia Recruiting
Manatee Memorial Hospital Bradenton Florida Terminated
Baptist Health Research Institute Jacksonville Florida Recruiting
Lakeland Vascular Institute Lakeland Florida Terminated
HCA Florida Largo Hospital Largo Florida Terminated
Sarasota Memorial Hospital Sarasota Florida Recruiting
BayCare Health System Tampa Florida Recruiting
Memorial Health University Medical Center Savannah Georgia Terminated
Community Healthcare System Munster Indiana Terminated
St. Elizabeth Edgewood Edgewood Kentucky Terminated
University of Maryland Baltimore Maryland Recruiting
McLaren Healthcare Bay City Michigan Recruiting
Henry Ford Health Detroit Michigan Recruiting
MyMichigan Medical Center Midland Michigan Recruiting
University of Missouri Columbia Missouri Recruiting
Saint Luke's Hospital of Kansas City Kansas City Missouri Terminated
St. Louis University St Louis Missouri Recruiting
University Medical Center of Southern Nevada Las Vegas Nevada Recruiting
Cooper University Hospital Camden New Jersey Recruiting
Holy Name Medical Center Teaneck New Jersey Terminated
Northwell Health Bay Shore New York Recruiting
NYP-Brooklyn Methodist Brooklyn New York Recruiting
SUNY, The University at Buffalo Buffalo New York Terminated
NYU Langone Medical Center New York New York Recruiting
Columbia University Irving Medical Center New York New York Recruiting
Mission Health Asheville North Carolina Terminated
Mercy Health - The Heart Institute Cincinnati Ohio Terminated
Cleveland Clinic Cleveland Ohio Recruiting
Saint Francis Hospital Tulsa Oklahoma Recruiting
Allegheny St. Vincent Hospital Erie Pennsylvania Recruiting
Thomas Jefferson University Philadelphia Pennsylvania Recruiting
Allegheny General Health Research Network Pittsburgh Pennsylvania Recruiting
Rhode Island Hospital Providence Rhode Island Recruiting

+ 24 more sites — see the full list on the official registry below.

More Inari Medical trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05701917 on ClinicalTrials.gov ↗ ← All trials in the USA