VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction

Not Applicable

Completed

• Conditions: Symptomatic Venous Outflow Obstruction of Iliofemoral Vein; Venous Outflow Obstruction; Chronic Venous Disorder
• Interventions: Device: Veniti Vici™ Venous Stent System

• Registration Number: NCT02112877
• Lead Sponsor: Boston Scientific Corporation

Brief 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.

Study Timeline

• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-14
• Study Start: 2014-06-26
• Primary Completion: 2017-12-05
• Disposition First Submitted: 2018-12-14
• Disposition First Submitted QC: 2018-12-17
• Disposition First Posted: 2018-12-19
• Results First Submitted: 2019-05-24
• Results First Submitted QC: 2019-07-09
• Results First Posted: 2019-07-30
• Study Completion: 2020-12-18
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
VICI Stent Implantation - Pivotal	Veniti Vici™ Venous Stent System	Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
VICI Stent Implantation - Feasibility	Veniti Vici™ Venous Stent System	Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System

Primary Outcome Measures

Name	Time	Method
Number of Participants With Major Adverse Events (MAE)	30 days	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.
Percentage of Participants That Demonstrated Primary Patency	12 months post-intervention	The primary effectiveness endpoint is the primary patency rate at 12 months post-intervention, defined as freedom from occlusion by thrombosis, freedom from surgical or endovascular intervention on target vessel which are found to have re-stenosis or stent occlusion to maintain patency, and freedom from in-stent stenosis more than 50% by venogram.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Improvement in Venous Clinical Severity Score (VCSS)	12 months post-intervention	The secondary effectiveness endpoint for this study will be a binary response variable based on an improvement in Venous Clinical Severity Score (VCSS) by at least 50% at 12 months post-intervention. VCSS measures 10 clinical attributes of venous disease (Pain, Varicose Veins, Venous Edema, Skin Pigmentation, Inflammation, Induration, No. Active Ulcers, Active Ulcer Size, Ulcer Duration and Compression Therapy) on a scale of 0 - 3 (Absent 0, Mild 1, Moderate 2, and Severe 3).

Trial Locations

Locations (24)

Michigan Vascular Center; 🇺🇸 Flint, Michigan, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

University Hospital Galway; 🇮🇪 Galway, Ireland

Rijnstate Ziekenhuis; 🇳🇱 Arnhem, Netherlands

Abrazo Arizona Heart Hospital; 🇺🇸 Phoenix, Arizona, United States

St. Joseph Hospital; 🇺🇸 Orange, California, United States

Radiology Imaging Associates; 🇺🇸 Englewood, Colorado, United States

New York Presbyterian Hospital/Cornell University; 🇺🇸 New York, New York, United States

Vascular Breakthroughs; 🇺🇸 Darien, Connecticut, United States

Dr. Ediberto Soto-Cora; 🇺🇸 El Paso, Texas, United States

University College London; 🇬🇧 London, United Kingdom

Healthfinity PLCC; 🇺🇸 Scottsdale, Arizona, United States

Arkansas Site Management Services, LLC; 🇺🇸 Little Rock, Arkansas, United States

Midwest Cardiovascular Foundation; 🇺🇸 Davenport, Iowa, United States

NYU School of Medicine; 🇺🇸 New York, New York, United States

Imperial Health, LLP; 🇺🇸 Lake Charles, Louisiana, United States

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Sentara Vascular Specialists; 🇺🇸 Norfolk, Virginia, United States

Infermerierie Protestante de Lyon; 🇫🇷 Decines Charpieu, France

Hôpital Nord de Marseille; 🇫🇷 Marsaille, France

Klinikum Arnsberg, Karolinen Hospital; 🇩🇪 Arnsberg, Germany

University Hospital HM Monteprincipe; 🇪🇸 Madrid, Spain

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom