At a glance
ClinicalIndex Comparison RecordN/ACompleted· 200 enrolled
Drug / intervention
Veniti Vici™ 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.
VIRTUS Safety and Efficacy of the Veniti Vici™ Venous Stent System (Veniti, Inc.) When Used to Treat Clinically Significant Chronic Non-malignant Obstruction of the Iliofemoral Venous Segment
In Brief
A clinical study evaluating Veniti Vici™ Venous Stent System for Chronic Venous Disorder and 2 related conditions. Completed, enrolled 200 participants across 24 sites in 7 countries.
Detailed Summary
This is a prospective, multi-center, single arm, non-randomized study to define safety and efficacy of the Veniti Vici™ Venous Stent System in relation to pre-defined Objective Performance goals. A maximum of 200 patients at up to 45 centers worldwide will be enrolled. Thirty (30) feasibility patients will be enrolled at approximately 7-10 centers and 170 pivotal patients will be enrolled at approximately 45 centers worldwide. The follow-up period is 36 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Venous Disorder, Venous Outflow Obstruction, Symptomatic Venous Outflow Obstruction of Iliofemoral Vein
CountriesFrance, Germany, Ireland, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartJun 2014
Primary CompletionDec 2017
Study CompletionDec 2020
TodayJul 2026
First PostedApr 14, 2014
Enrollment StartJun 26, 2014
Primary CompletionDec 5, 2017
Study CompletionDec 18, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 12.2 years ago
Interventions
Veniti Vici™ Venous Stent Systemdevice