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

Study Overview
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Brief Summary
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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.

Detailed Description
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The study will compare the clinical outcomes of patients treated with 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 symptomatic unilateral iliofemoral DVT. Up to 300 subjects will be enrolled and randomized. All subjects who sign informed consent and who meet all of the inclusion criteria and none of the exclusion criteria will be randomized (1:1, ClotTriever Intervention Arm or Conservative Medical Management Arm).

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

Conditions
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Venous Thromboembolism, Deep Venous Thrombosis, Post-Thrombotic Syndrome

Intervention / Treatment
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* Device: ClotTriever System
* Drug: Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interventional<br>Interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm). | Device: ClotTriever System<br>* Mechanical thrombectomy<br>|
| Active Comparator: Conservative Medical Management<br>Conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm). | Drug: Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.<br>* Anticoagulants are a group of medications that decrease your blood's ability to clot.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: | Occurrence of treatment failure or therapy escalation Assessment of PTS severity, as defined by the Villalta scale | 180 Days (+-14 Days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: | Vessel compressibility assessed by duplex ultrasound Pain as assessed by the NPRS An improvement of edema as assessed by leg calf circumference measurements | 10 Days (+- 3 Days) | 
| Assessment of PTS Severity: | a. Assessment of PTS severity, as defined by the Villalta scale | 180 Days (+-14 Days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous Thromboembolism, Deep Venous Thrombosis, Post-Thrombotic Syndrome, Anticoagulation, Percutaneous Mechanical Thrombectomy