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

March 24, 2021 updated by: Boston Scientific Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Decines Charpieu, France
        • Infermerierie Protestante de Lyon
      • Marsaille, France
        • Hôpital 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 Montepríncipe
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Major Adverse Events (MAE)
Time Frame: 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.
30 days
Percentage of Participants That Demonstrated Primary Patency
Time Frame: 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.
12 months post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Improvement in Venous Clinical Severity Score (VCSS)
Time Frame: 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).
12 months post-intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Procedural Technical Success
Time Frame: During Procedure
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
Time Frame: During Procedure
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
Time Frame: 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)
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
Time Frame: 12 months post-intervention
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))
Time Frame: Baseline and 12 months post-intervention
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
Time Frame: 12 months post-intervention
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
Time Frame: 36 months post-intervention
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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