CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 162 enrolled
Drug / intervention
Duo Venous Stent Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04580160
NCT04580160N/ACompleted
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Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System

Vesper Medical, Inc.·interventional·Posted Oct 8, 2020·Updated May 15, 2025

In Brief

A clinical study evaluating Duo Venous Stent System for May-Thurner Syndrome and 2 related conditions. Completed, enrolled 162 participants across 30 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMay-Thurner Syndrome, Deep Vein Thrombosis, Chronic Venous Insufficiency
CountriesPoland, United States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 8, 2020
Enrollment StartNov 30, 2020
Primary CompletionDec 3, 2022
Study CompletionApr 15, 2025
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.7 years ago

Interventions

Duo Venous Stent Systemdevice

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.