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

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.

Inclusion CriteriaAge ≥ 18 yearsProximal lower extremity unilateral DVT involving at least the common femoral, external iliac, or common iliac veins, alone or in combinationSymptom onset within 12 weeks of enrollment in the studySignificant symptoms, as defined by a Villalta score > 9Willing and able to provide informed consentExclusion CriteriaBilateral iliofemoral DVTPrior venous stent in the target venous segmentIVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veinsIVC filter in place at the time of enrollmentLimb-threatening circulatory compromise (e.g., phlegmasia)Clot in transit including IVC thrombus presenting as extension of >2cm into the IVC from the CIVSymptomatic 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 judgementSevere allergy, hypersensitivity to, or thrombocytopenia from heparinSevere allergy to iodinated contrast agents that cannot be mitigatedHemoglobin < 8.0 g/dL, INR > 1.7 before warfarin was started, or platelets < 50,000/µl which cannot be corrected prior to enrollmentSevere renal impairment (estimated GFR < 30 ml/min) in patients who are not yet on dialysisInability to provide therapeutic anticoagulation per Investigator discretionUncontrolled severe hypertension on repeated readings (systolic > 180mmHg or diastolic > 105mmHg)Recently (< 30 days) had DVT interventional procedureSubject is participating in another study that may interfere with this studyLife expectancy < 6 months or chronic non-ambulatory statusKnown hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study periodSubject 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 studyPatient unwilling or unable to conduct the follow up visits per protocol