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

NCT ID: NCT02112877

Last Updated: 2021-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-26
• Study Completion Date: 2020-12-18

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.

Conditions

Chronic Venous Disorder; Venous Outflow Obstruction; Symptomatic Venous Outflow Obstruction of Iliofemoral Vein

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VICI Stent Implantation - Feasibility

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System

Group Type: EXPERIMENTAL

Veniti Vici™ Venous Stent System

Intervention Type: DEVICE

VICI Stent Implantation - Pivotal

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System

Group Type: EXPERIMENTAL

Veniti Vici™ Venous Stent System

Intervention Type: DEVICE

Interventions

Veniti Vici™ Venous Stent System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Willing and capable of complying with all follow-up evaluations at the specified times
• Able and willing to provide written informed consent prior to study-specific procedures
• Presence of unilateral, clinically significant, chronic non-malignant obstruction of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof, defined as a ≥50% reduction in target vessel lumen diameter (to be measured by venogram during procedure)
• Clinically significant venous obstruction defined as meeting at least one of the following clinical indicators:

• Clinical severity class of CEAP classification ≥3
• VCSS Pain Score ≥2
• Negative pregnancy test in females of child-bearing potential
• Intention to stent the target lesion only with the Veniti Vici Venous Stent

Exclusion Criteria

• Presence or history of clinically significant pulmonary emboli within 6 months prior to enrollment.
• Venous obstruction that extends into the inferior vena cava (IVC)
• Contralateral disease of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof with planned treatment within 30 days after subject enrollment
• Life expectancy <12 months
• Female of childbearing potential who is pregnant or plans to become pregnant during the duration of the clinical study
• Uncontrolled or active coagulopathy OR known, uncorrectable bleeding diathesis with the following definitions:

• Uncorrected INR ≥2.0 or aPTT ≥1.5 X normal local lab value
• Platelet count <80,000
• Uncorrected hemoglobin of ≤ 9 g/dL
• Patients with an estimated glomerular filtration rate (eGFR) <30 mL/min. In patients with diabetes mellitus, eGFR <45 mL/min.
• Known hypersensitivity to nickel or titanium
• Contrast agent allergy that cannot be managed adequately with pre-medication
• Intended concurrent thrombolysis or thrombectomy procedure OR intended or planned (within 30 days) adjuvant procedure such as creation of temporary arteriovenous fistula, placement of IVC filter, endovenectomy or saphenous vein ablation
• Current or recent (within 30 days) active participation in another drug or device clinical trial (Participation in observational studies is acceptable.)
• Patient judged to be a poor candidate by the primary investigator
• Patients who have had any prior surgical or endovascular intervention of the target vessel [Note: Patients who have had catheter-directed or mechanical thrombolysis in the target vessel for DVT at least 3 month (90 days) prior to the VIRTUS index procedure may be included in the trial.]

• Patients in whom the lesions cannot be traversed with a guide wire.
• Patients where the obstruction extends into the inferior vena cava or below the level of the lesser trochanter.
• Patients whose vein diameters are not within limits stated in current Instructions for Use as determined by venogram.
• Patients who do not meet the venogram binary stenosis definition, as determined by the treating physician.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Marston, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Department of Surgery

Mahmood Razavi, MD

Role: PRINCIPAL_INVESTIGATOR

Vascular and Interventional Specialists of Orange County

Locations

Abrazo Arizona Heart Hospital

Phoenix, Arizona, United States

Healthfinity PLCC

Scottsdale, Arizona, United States

Arkansas Site Management Services, LLC

Little Rock, Arkansas, United States

St. Joseph Hospital

Orange, California, United States

Radiology Imaging Associates

Englewood, Colorado, United States

Vascular Breakthroughs

Darien, Connecticut, United States

Midwest Cardiovascular Foundation

Davenport, Iowa, United States

Imperial Health, LLP

Lake Charles, Louisiana, United States

Michigan Vascular Center

Flint, Michigan, United States

NYU School of Medicine

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

New York Presbyterian Hospital/Cornell University

New York, New York, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Dr. Ediberto Soto-Cora

El Paso, Texas, United States

Sentara Vascular Specialists

Norfolk, Virginia, United States

University of Washington Medical Center

Seattle, Washington, United States

Infermerierie Protestante de Lyon

Décines-Charpieu, , France

Hôpital Nord de Marseille

Marsaille, , France

Klinikum Arnsberg, Karolinen Hospital

Arnsberg, , Germany

University Hospital Galway

Galway, , Ireland

Rijnstate Ziekenhuis

Arnhem, , Netherlands

University Hospital HM Monteprincipe

Madrid, , Spain

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

University College London

London, , United Kingdom

Countries

United States; France; Germany; Ireland; Netherlands; Spain; United Kingdom

References

Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.

Reference Type: DERIVED

PMID: 39968829 (View on PubMed)

Razavi MK, Black S, Gagne P, Chiacchierini R, Nicolini P, Marston W; VIRTUS Investigators. Pivotal Study of Endovenous Stent Placement for Symptomatic Iliofemoral Venous Obstruction. Circ Cardiovasc Interv. 2019 Dec;12(12):e008268. doi: 10.1161/CIRCINTERVENTIONS.119.008268. Epub 2019 Dec 13.

Reference Type: DERIVED

PMID: 31833414 (View on PubMed)

Razavi M, Marston W, Black S, Bentley D, Neglen P. The initial report on 1-year outcomes of the feasibility study of the VENITI VICI VENOUS STENT in symptomatic iliofemoral venous obstruction. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):192-200. doi: 10.1016/j.jvsv.2017.10.014. Epub 2017 Dec 28.

Reference Type: DERIVED

PMID: 29290601 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STE-HUM-007P

Identifier Type: OTHER

Identifier Source: secondary_id

STE-HUM-004P

Identifier Type: -

Identifier Source: org_study_id