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Compares treatment options for Venous Thromboembolism
Official title DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
ClinicalTrials.gov ID: NCT05701917
What this study is testing
What is Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.?
Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc. is an investigational medicine, being studied as a potential treatment for venous thromboembolism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 \ 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 treatment 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...
- Subject has previously completed or withdrawn from this study
- Patient unwilling or unable to conduct the follow up visits per protocol
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Orange, California, United States
- Pasadena, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Bradenton, Florida, United States
- Jacksonville, Florida, United States
- Lakeland, Florida, United States
- Largo, Florida, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Savannah, Georgia, United States
- Munster, Indiana, United States
- Edgewood, Kentucky, United States
- Baltimore, Maryland, United States
- Bay City, Michigan, United States
- Detroit, Michigan, United States
- Midland, Michigan, United States
+ 41 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Tucson, Arizona, United States; Orange, California, United States; Pasadena, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States and 55 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.