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RECRUITINGINTERVENTIONAL

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

DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

ClotTriever System

Mechanical thrombectomy

DRUG

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.

Locations (20)

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
Huntington Health
Pasadena, 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