Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02112877
Recruitment Status : Active, not recruiting
First Posted : April 14, 2014
Results First Posted : July 30, 2019
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE April 10, 2014
First Posted Date  ICMJE April 14, 2014
Results First Submitted Date  ICMJE May 24, 2019
Results First Posted Date  ICMJE July 30, 2019
Last Update Posted Date April 30, 2020
Actual Study Start Date  ICMJE June 26, 2014
Actual Primary Completion Date December 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
  • Primary Safety Endpoint [ Time Frame: 30 days ]
    Major Adverse Events within 30 days.
  • Primary Efficacy Endpoint [ Time Frame: 12 months post-intervention ]
    Primary patency rate
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
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).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: July 9, 2019)
  • 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.
  • 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).
  • 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.
  • 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 .
  • 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.
  • 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.
  • Number of Participants With Estimated Secondary Patency [ Time Frame: 60 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).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction
Official Title  ICMJE 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
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 60 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Venous Disorder
  • Venous Outflow Obstruction
  • Symptomatic Venous Outflow Obstruction of Iliofemoral Vein
Intervention  ICMJE Device: Veniti Vici™ Venous Stent System
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: Device: Veniti Vici™ Venous Stent System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 10, 2014)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Actual Primary Completion Date December 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Ireland,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02112877
Other Study ID Numbers  ICMJE STE-HUM-004P
STE-HUM-007P ( Other Identifier: Sponsor )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William Marston, MD UNC Department of Surgery
Principal Investigator: Mahmood Razavi, MD Vascular and Interventional Specialists of Orange County
PRS Account Boston Scientific Corporation
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP