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

NCT02112877 | Completed Results DMC FDA Device

• 2 other identifiers: STE-HUM-004PSTE-HUM-007P
• Study Type: interventional
• Target: 200
• Locations: 7 countries
• Sites: 24

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.

Conditions

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

Keywords

iliofemoral vein; venous; venous obstruction

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Major Adverse Events (MAE)

  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.

  30 days

• Percentage of Participants That Demonstrated Primary Patency

  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.

  12 months post-intervention

Secondary Outcomes (1)

• Number of Participants With Improvement in Venous Clinical Severity Score (VCSS)

  12 months post-intervention

Other Outcomes (7)

• Number of Participants With Procedural Technical Success

  During Procedure

• Number of Participants With Lesion Success

  During Procedure

• Number of Participants With Procedural Success

  From the time of the Index Procedure post procedural venogram through the time of Index Procedure Discharge or 3 days Post-Procedure (whichever comes first)

Study Arms (2)

VICI Stent Implantation - Feasibility

EXPERIMENTAL

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

Device: Veniti Vici™ Venous Stent System

VICI Stent Implantation - Pivotal

EXPERIMENTAL

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

Device: Veniti Vici™ Venous Stent System

Interventions

Veniti Vici™ Venous Stent System DEVICE

VICI Stent Implantation - Feasibility; VICI Stent Implantation - Pivotal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (24)

Abrazo Arizona Heart Hospital

Phoenix, Arizona, 85016, United States

Location

Healthfinity PLCC

Scottsdale, Arizona, 85254, United States

Location

Arkansas Site Management Services, LLC

Little Rock, Arkansas, 72211, United States

Location

St. Joseph Hospital

Orange, California, 92868, United States

Location

Radiology Imaging Associates

Englewood, Colorado, 80112, United States

Location

Vascular Breakthroughs

Darien, Connecticut, 06820, United States

Location

Midwest Cardiovascular Foundation

Davenport, Iowa, 52803, United States

Location

Imperial Health, LLP

Lake Charles, Louisiana, 70601, United States

Location

Michigan Vascular Center

Flint, Michigan, 48507, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

New York Presbyterian Hospital/Cornell University

New York, New York, 10065, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Dr. Ediberto Soto-Cora

El Paso, Texas, 79925, United States

Location

Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Infermerierie Protestante de Lyon

Décines-Charpieu, France

Location

Hôpital Nord de Marseille

Marsaille, France

Location

Klinikum Arnsberg, Karolinen Hospital

Arnsberg, Germany

Location

University Hospital Galway

Galway, Ireland

Location

Rijnstate Ziekenhuis

Arnhem, Netherlands

Location

University Hospital HM Monteprincipe

Madrid, Spain

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

University College London

London, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 39968829 DERIVED

• 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.

  PMID: 31833414 DERIVED

• 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.

  PMID: 29290601 DERIVED

Results Point of Contact

• Title: Nancy O'Connell, Sr. Clinical Research Manager
• Organization: Boston Scientific

nancy.oconnell@bsci.com

763-494-2706

Study Officials

• William Marston, MD

  UNC Department of Surgery

  PRINCIPAL INVESTIGATOR

• Mahmood Razavi, MD

  Vascular and Interventional Specialists of Orange County

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Thirty (30) patients will be enrolled at approximately 7 centers (feasibility cohort). These patients will not be included in the pivotal study population, but will be evaluated separately for the primary safety and efficacy endpoints as well as for all secondary endpoints. When these 30 feasibility patients have completed their 30-day follow-up, a Data Safety Monitoring Board (DSMB) will review the safety data and will determine if the study can proceed with enrollment of the 170 pivotal subjects.

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 14, 2014
• Study Start: June 26, 2014
• Primary Completion: December 5, 2017
• Study Completion: December 18, 2020
• Last Updated: April 15, 2021
• Results First Posted: July 30, 2019

Record last verified: 2021-03

Locations

ES (1); GB (2); DE (1); FR (2); IE (1); US (16); NL (1)