NCT05701917 · Inari Medical
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
(DEFIANCE)
What this study is about
This study is a forward-looking, conducted at multiple hospitals, randomly assigned controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention treatment group$1) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management treatment group$1) 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.
View original scientific description
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 can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Scottsdale, Arizona
- Tucson, Arizona
- Orange, California
- Pasadena, California
- Denver, Colorado
- New Haven, Connecticut
- Washington D.C., District of Columbia
- Bradenton, Florida
- Jacksonville, Florida
- Lakeland, Florida
- Largo, Florida
- Sarasota, Florida
And 34 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations