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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Veniti
Sponsor:
Information provided by (Responsible Party):
Veniti
ClinicalTrials.gov Identifier:
NCT02112877
First received: April 10, 2014
Last updated: January 13, 2017
Last verified: January 2017
  Purpose
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 Intervention
Chronic Venous Disorder
Venous Outflow Obstruction
Symptomatic Venous Outflow Obstruction of Iliofemoral Vein
Device: Veniti Vici™ Venous Stent System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Veniti:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: April 2014
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Veniti Vici™ Venous Stent System 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 with clinically significant chronic non-malignant obstruction of the iliofemoral venous outflow tract.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112877

  Show 31 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
  More Information

Responsible Party: Veniti
ClinicalTrials.gov Identifier: NCT02112877     History of Changes
Other Study ID Numbers: STE-HUM-004P  STE-HUM-007P 
Study First Received: April 10, 2014
Last Updated: January 13, 2017

Keywords provided by Veniti:
iliofemoral vein
venous
venous obstruction

ClinicalTrials.gov processed this record on February 17, 2017