Trials / Completed
CompletedNCT02112877
VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The objective of this prospective study is to assess the safety and efficacy of the Veniti Vici™ Venous Stent System in achieving patency of the target venous lesion in patients who present with clinically significant chronic non-malignant obstruction of the iliofemoral venous outflow tract.
Conditions
- Chronic Venous Disorder
- Venous Outflow Obstruction
- Symptomatic Venous Outflow Obstruction of Iliofemoral Vein
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Veniti Vici™ Venous Stent System |
Timeline
- Start date
- 2014-06-26
- Primary completion
- 2017-12-05
- Completion
- 2020-12-18
- First posted
- 2014-04-14
- Last updated
- 2021-04-15
- Results posted
- 2019-07-30
Locations
24 sites across 7 countries: United States, France, Germany, Ireland, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02112877. Inclusion in this directory is not an endorsement.