Health Trials

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

300 Participants
are divided into 2 treatment groups

Locations

64
Austria
Vienna General Hospital (AKH Wien) Vienna Austria
Finland
Helsinki University Hospital Helsinki Finland
Germany
Universitätsklinikum Tübingen72076, TübingenBaden-Würtemberg, Germany
MVZ CCB Frankfurt und Main-Taunus GbR60389, Frankfurt am MainHesse, Germany

Sponsors and collaborators

Inari Medical

Lead sponsor

Source ClinicalTrials.gov