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NCT02112877 · ClinicalTrials.gov registry record · NA
VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction
A NA study of Chronic Venous Disorder and Venous Outflow Obstruction, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT02112877: Completed NA study of Chronic Venous Disorder and Venous Outflow Obstruction, sponsored by Boston Scientific Corporation.
NCT02112877 is a NA study of Chronic Venous Disorder and Venous Outflow Obstruction that has completed, run by Boston Scientific Corporation. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02112877, a NA study of Chronic Venous Disorder and Venous Outflow Obstruction, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The primary safety endpoint for this study will be a composite endpoint of any major adverse event (MAE) within 30 days, as adjudicated by a Clinical Events Committee.
Conditions Studied
Interventions
- DEVICE Veniti Vici™ Venous Stent System
Study Locations (20)
Other
- Infermerierie Protestante de Lyon - Décines-Charpieu
- Hôpital Nord de Marseille - Marsaille
- Klinikum Arnsberg, Karolinen Hospital - Arnsberg
- University Hospital Galway - Galway
New York
- NYU School of Medicine - New York
- Icahn School of Medicine at Mount Sinai - New York
- New York Presbyterian Hospital/Cornell University - New York
Arizona
- Abrazo Arizona Heart Hospital - Phoenix
- Healthfinity PLCC - Scottsdale
Arkansas
- Arkansas Site Management Services, LLC - Little Rock
California
- St. Joseph Hospital - Orange
Colorado
- Radiology Imaging Associates - Englewood
Connecticut
- Vascular Breakthroughs - Darien
Iowa
- Midwest Cardiovascular Foundation - Davenport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2014-06-26 |
| Est. Completion | 2020-12-18 |
| Phase | NA |
What the finished NCT02112877 record still lists
NCT02112877 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 3 conditions, with Chronic Venous Disorder appearing as the primary indexed condition, and to 1 intervention - of which Veniti Vici™ Venous Stent System is the first listed.
NCT02112877 names 20 study sites across 14 states, led by Other, New York, Arizona.
Frequently Asked Questions
What is clinical trial NCT02112877 about?
NCT02112877 is a clinical study titled "VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction". 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 patien...
What is the current status of trial NCT02112877?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2014-06-26. Estimated completion is 2020-12-18.
What conditions does trial NCT02112877 study?
This clinical trial studies the following conditions: Chronic Venous Disorder, Venous Outflow Obstruction, Symptomatic Venous Outflow Obstruction of Iliofemoral Vein.
What interventions are being tested in trial NCT02112877?
The interventions under investigation include: Veniti Vici™ Venous Stent System (DEVICE).
Who is sponsoring clinical trial NCT02112877?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02112877 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02112877's enrollment target sits among peer trials
200 506th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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