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

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ClinicalTrials.gov Identifier: NCT02112877
Recruitment Status : Active, not recruiting
First Posted : April 14, 2014
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Chronic Venous Disorder Venous Outflow Obstruction Symptomatic Venous Outflow Obstruction of Iliofemoral Vein Device: Veniti Vici™ Venous Stent System Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2014
Actual Primary Completion Date : December 5, 2017
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Experimental: Veniti Vici™ Venous Stent System
Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein
Device: Veniti Vici™ Venous Stent System



Primary Outcome Measures :
  1. Rate of 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.

  2. Rate of 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.


Secondary Outcome Measures :
  1. 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 9 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).


Other Outcome Measures:
  1. 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.

  2. Number of Treated Lesions 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).

  3. 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.

  4. 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 .

  5. Change in the Quality of Life (Chronic Venous Insufficiency Questionnaire)(CIVIQ2)) [ Time Frame: 12 months post-intervention ]
    The overall change in CIVIQ2 scores for the study patients, calculated using the area under the curve and presented with mean and 95% confidence intervals.

  6. Rate of Estimated Primary 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.

  7. Rate of 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112877


  Show 24 Study Locations
Sponsors and Collaborators
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02112877     History of Changes
Other Study ID Numbers: STE-HUM-004P
STE-HUM-007P ( Other Identifier: Sponsor )
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Boston Scientific Corporation:
iliofemoral vein
venous
venous obstruction