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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Venous Disorder; Venous Outflow Obstruction; Symptomatic Venous Outflow Obstruction of Iliofemoral Vein
• Intervention / Treatment: Device: Veniti Vici™ Venous Stent System

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Decines Charpieu, France
    • Infermerierie Protestante de Lyon
  • Marsaille, France
    • Hopital Nord de Marseille
• Germany
  • Arnsberg, Germany
    • Klinikum Arnsberg, Karolinen Hospital
• Ireland
  • Galway, Ireland
    • University Hospital Galway
• Netherlands
  • Arnhem, Netherlands
    • Rijnstate Ziekenhuis
• Spain
  • Madrid, Spain
    • University Hospital HM Monteprincipe
• United Kingdom
  • London, United Kingdom
    • University College London
  • London, United Kingdom
    • Guy's and St Thomas' NHS Foundation Trust
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Abrazo Arizona Heart Hospital
    • Scottsdale, Arizona, United States, 85254
      • Healthfinity PLCC
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Site Management Services, LLC
  • California
    • Orange, California, United States, 92868
      • St. Joseph Hospital
  • Colorado
    • Englewood, Colorado, United States, 80112
      • Radiology Imaging Associates
  • Connecticut
    • Darien, Connecticut, United States, 06820
      • Vascular Breakthroughs
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Midwest Cardiovascular Foundation
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Imperial Health, LLP
  • Michigan
    • Flint, Michigan, United States, 48507
      • Michigan Vascular Center
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10016
      • NYU School of Medicine
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital/Cornell University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • The University of North Carolina at Chapel Hill
  • Texas
    • El Paso, Texas, United States, 79925
      • Dr. Ediberto Soto-Cora
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Vascular Specialists
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria - Pre-Procedure 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 - Pre-Procedure 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.]

Exclusion Criteria - Intra-Procedural Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Veniti Vici™ Venous Stent System
Experimental: 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	Device: Veniti Vici™ Venous Stent System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Improvement in Venous Clinical Severity Score (VCSS)	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).	12 months post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Procedural Technical Success	Procedural technical success is achievement of a final residual target vessel diameter stenosis of ≤50% as measured on the post procedural venogram, without skipped lesion regions, with placement of the study device alone with or without post-stenting balloon dilation as needed.	During Procedure
Number of Participants With Lesion Success	Lesion success is defined as achievement of ≤50% residual diameter stenosis of the target lesion using any percutaneous method (including the use of non-study devices).	During Procedure
Number of Participants With Procedural Success	Procedural success is defined as procedural technical success without the occurrence of a major adverse event (MAE) between the index procedure and discharge.	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)
Number of Participants With Late Technical Success	Late technical success (through 12 months) is the absence of device movement >10mm related to anatomical landmarks or any migration leading to symptoms or requiring therapy; absence of stent occlusion by thrombosis or restenosis, defined as reduction in treated segment lumen more than 50% from the post-procedure vessel lumen diameter as measured by post-procedural venogram or DUS and maintenance of structural integrity, defined as the absence of pinching (focal compression), kinking (stent doubling or bending upon itself) that results in >50% diameter reduction of the stent, recoil (poor radial resistive force) or absence of fractures .	12 months post-intervention
Change in the Quality of Life (Chronic Venous Insufficiency Questionnaire)(CIVIQ2))	The overall change in CIVIQ2 scores for the study patients, calculated using the mean scores at baseline and 12-months. This instrument is scored from 20 to 100 points with lower scores indicating a lesser impact on health.	Baseline and 12 months post-intervention
Number of Participants With Estimated Primary-Assisted Patency	Primary-assisted patency is defined as freedom from occlusion regardless of whether an intervention (subsequent to the index procedure) was performed.	12 months post-intervention
Number of Participants With Estimated Secondary Patency	Secondary patency is defined as freedom from "permanent" loss of patency determined through last follow-up (irrespective of the number of interventions).	36 months post-intervention

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: William Marston, MD, UNC Department of Surgery; Principal Investigator: Mahmood Razavi, MD, Vascular and Interventional Specialists of Orange County

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2014
• Primary Completion (Actual): December 5, 2017
• Study Completion (Actual): December 18, 2020

Study Registration Dates

• First Submitted: April 10, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 14, 2014

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: venous; iliofemoral vein; venous obstruction
• Other Study ID Numbers: STE-HUM-004P; STE-HUM-007P (Other Identifier: Sponsor)

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes