NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT05701917

RecruitingNA

Sponsor: Inari Medical

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

Interventions: ClotTriever System, Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.

Countries: United States, Austria, Finland, Germany, Switzerland, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (64)

Scottsdale, Arizona, United States
Tucson, Arizona, United States
Orange, California, 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
Columbia, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Camden, New Jersey, United States
Teaneck, New Jersey, United States
Bay Shore, New York, United States
Brooklyn, New York, United States
Buffalo, New York, United States
+ 34 more on CT.gov