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

ConditionsVenous ThromboembolismDeep Venous ThrombosisPost-Thrombotic Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInari Medical

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ClotTriever System

    Device

    Mechanical thrombectomy

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

    Drug

    Anticoagulants are a group of medications that decrease your blood's ability to clot.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: InterventionalActive comparator 1 intervention
Group B: Conservative Medical ManagementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:

1. Occurrence of treatment failure or therapy escalation 2. Assessment of PTS severity, as defined by the Villalta scale

Time frame
180 Days (+-14 Days)

Secondary outcomes

1

Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:

1. Vessel compressibility assessed by duplex ultrasound 2. Pain as assessed by the NPRS 3. An improvement of edema as assessed by leg calf circumference measurements

Time frame
10 Days (+- 3 Days)
2

Assessment of PTS Severity:

a. Assessment of PTS severity, as defined by the Villalta scale

Time frame
180 Days (+-14 Days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inari Medical

Lead sponsor

Source ClinicalTrials.gov
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