NCT05701917

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

DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Inari Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study will compare the clinical outcomes of patients treated with 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 symptomatic unilateral iliofemoral DVT. Approximately 300 subjects will be enrolled and randomized. All subjects who sign informed consent and who meet all of the inclusion criteria and none of the exclusion criteria will be randomized (1:1, ClotTriever Intervention Arm or Conservative Medical Management Arm).

Conditions

• Venous Thromboembolism
• Deep Venous Thrombosis
• Post-Thrombotic Syndrome

Interventions

Type	Name	Description
DEVICE	ClotTriever System	Mechanical thrombectomy
DRUG	Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.	Anticoagulants are a group of medications that decrease your blood's ability to clot.

Timeline

• Start date: 2023-01-06
• Primary completion: 2026-06-30
• Completion: 2027-01-15
• First posted: 2023-01-27
• Last updated: 2026-03-31

Locations

64 sites across 6 countries: United States, Austria, Finland, Germany, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study