NCT04580160

Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Vesper Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, single-arm, non-blinded clinical trial designed to investigate the safety and efficacy of the Vesper DUO Venous Stent System as compared to a pre-defined performance goal (PG) established from published, peer reviewed scientific literature related to stenting of iliofemoral venous outflow obstructions.

Conditions

• May-Thurner Syndrome
• Deep Vein Thrombosis
• Chronic Venous Insufficiency

Interventions

Type	Name	Description
DEVICE	Duo Venous Stent System	Subjects with nonmalignant iliofemoral venous outflow obstruction presenting with nonthrombotic (NT), acute thrombotic (AT) or chronic postthrombotic (CPT) disease pathogenesis will be selected for study participation.

Timeline

• Start date: 2020-11-30
• Primary completion: 2022-12-03
• Completion: 2025-04-15
• First posted: 2020-10-08
• Last updated: 2025-05-15
• Results posted: 2025-01-13

Locations

30 sites across 2 countries: United States, Poland

Regulatory

• FDA-regulated device study