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

Venous Thromboembolism Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. Up to 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). ;

Related Conditions & MeSH terms

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

• NCT number: NCT05701917
• Study type: Interventional
• Source: Inari Medical
• Contact: Christine Wills
• Phone: 6027992920
• Email: christine.wills@inarimedical.com
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2023
• Completion date: October 31, 2025