Status:
RECRUITING
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Lead Sponsor:
Inari Medical
Conditions:
Venous Thromboembolism
Deep Venous Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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) v...
Detailed Description
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) vers...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05701917
Start Date
January 6 2023
End Date
January 15 2027
Last Update
February 4 2026
Active Locations (63)
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1
Honor Health
Scottsdale, Arizona, United States, 85258
2
Pima Heart and Vascular
Tucson, Arizona, United States, 85704
3
UCI Medical Center
Orange, California, United States, 92868
4
Vascular and Interventional Specialists of Orange County
Orange, California, United States, 92868