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VIRTUS: An Evaluation of the Veniti 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
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Veniti

Brief Summary:
This is a multi-center, prospective, single arm, non-randomized study to evaluate safety and efficacy of the Veniti Vici™ Venous Stent System in relation to pre-defined Objective Performance goals. 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 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-OUS 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 Device: Veniti Vici™ Venous Stent System



Primary Outcome Measures :
  1. Primary Safety Endpoint [ Time Frame: 30 days ]
    Major Adverse Events within 30 days.

  2. Primary Efficacy Endpoint [ Time Frame: 12 months post-intervention ]
    Primary patency rate



Information from the National Library of Medicine

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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 procedure 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 23 Study Locations
Sponsors and Collaborators
Veniti
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: Veniti
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: March 6, 2018
Last Verified: March 2018

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

Keywords provided by Veniti:
iliofemoral vein
venous
venous obstruction