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

Not Applicable

Recruiting

• Conditions: Venous Thromboembolism; Deep Venous Thrombosis; Post-Thrombotic Syndrome
• Interventions: Device: ClotTriever System

• Registration Number: NCT05701917
• Lead Sponsor: Inari Medical

Brief 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).

Study Timeline

• Study Start: 2023-01-06
• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-27
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-07
• Last Update Posted: 2025-10-09
• Primary Completion: 2026-06-30
• Study Completion: 2027-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	ClotTriever System	Interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm).

Primary Outcome Measures

Name	Time	Method
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:	180 Days (+-14 Days)	1. Occurrence of treatment failure or therapy escalation; 2. Assessment of PTS severity, as defined by the Villalta scale

Secondary Outcome Measures

Name	Time	Method
Assessment of PTS Severity:	180 Days (+-14 Days)	a. Assessment of PTS severity, as defined by the Villalta scale
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:	10 Days (+- 3 Days)	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

Trial Locations

Locations (60)

University Medical Center of Southern Nevada; 🇺🇸 Las Vegas, Nevada, United States

Honor Health; 🇺🇸 Scottsdale, Arizona, United States

Pima Heart and Vascular; 🇺🇸 Tucson, Arizona, United States

UCI Medical Center; 🇺🇸 Orange, California, United States

Vascular and Interventional Specialists of Orange County; 🇺🇸 Orange, California, United States

University Of Colorado; 🇺🇸 Denver, Colorado, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

MedStar Health Research Institution; 🇺🇸 Washington D.C., District of Columbia, United States

Manatee Memorial Hospital; 🇺🇸 Bradenton, Florida, United States

Lakeland Vascular Institute; 🇺🇸 Lakeland, Florida, United States

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