Comparison of ClotTriever System and Anticoagulation for Deep Vein Thrombosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of the ClotTriever System in treating symptomatic unilateral iliofemoral deep vein thrombosis (DVT) compared to standard anticoagulation therapy. It is a multicenter, randomized controlled trial that will enroll up to 300 participants who meet specific inclusion criteria. Participants will be randomly assigned to either the ClotTriever Intervention Arm or the Conservative Medical Management Arm, and their clinical outcomes will be monitored over a six-month follow-up period. Data collected will include demographics, comorbidities, and details regarding DVT diagnosis and treatment.

Why it matters

Who can join: the full rules

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 it's running

• Honor Health
  Scottsdale, Arizona, United States Recruiting
• Pima Heart and Vascular
  Tucson, Arizona, United States Recruiting
• UCI Medical Center
  Orange, California, United States Recruiting
• Vascular and Interventional Specialists of Orange County
  Orange, California, United States Recruiting
• Huntington Health
  Pasadena, California, United States Recruiting
• University Of Colorado
  Denver, Colorado, United States Recruiting

+14 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Steven Abramowitz, MD — MedStar Health Research Institution
• Study coordinator: Mark Sung
• Email: mark.sung@stryker.com
• Phone: 949-466-9458

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.