Clinical trial NCT02112877: VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Venous Disorder
Venous Outflow Obstruction
Symptomatic Venous Outflow Obstruction of Iliofemoral Vein
Keywords: iliofemoral vein
venous
venous obstruction
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-04-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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 36 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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Major Adverse Events (MAE)
timeFrame: 30 days
measure: Percentage of Participants That Demonstrated Primary Patency
timeFrame: 12 months post-intervention
Secondary outcomes:
measure: Number of Participants With Improvement in Venous Clinical Severity Score (VCSS)
timeFrame: 12 months post-intervention
Other outcomes:
measure: Number of Participants With Procedural Technical Success
timeFrame: During Procedure
measure: Number of Participants With Lesion Success
timeFrame: During Procedure
measure: Number of Participants With Procedural Success
timeFrame: 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)
measure: Number of Participants With Late Technical Success
timeFrame: 12 months post-intervention
measure: Change in the Quality of Life (Chronic Venous Insufficiency Questionnaire)(CIVIQ2))
timeFrame: Baseline and 12 months post-intervention
measure: Number of Participants With Estimated Primary-Assisted Patency
timeFrame: 12 months post-intervention
measure: Number of Participants With Estimated Secondary Patency
timeFrame: 36 months post-intervention
Locations:
city: Phoenix
country: United States
facility: Abrazo Arizona Heart Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Healthfinity PLCC
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Site Management Services, LLC
state: Arkansas
city: Orange
country: United States
facility: St. Joseph Hospital
state: California
city: Englewood
country: United States
facility: Radiology Imaging Associates
state: Colorado
city: Darien
country: United States
facility: Vascular Breakthroughs
state: Connecticut
city: Davenport
country: United States
facility: Midwest Cardiovascular Foundation
state: Iowa
city: Lake Charles
country: United States
facility: Imperial Health, LLP
state: Louisiana
city: Flint
country: United States
facility: Michigan Vascular Center
state: Michigan
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital/Cornell University
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: El Paso
country: United States
facility: Dr. Ediberto Soto-Cora
state: Texas
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Decines Charpieu
country: France
facility: Infermerierie Protestante de Lyon
city: Marsaille
country: France
facility: Hôpital Nord de Marseille
city: Arnsberg
country: Germany
facility: Klinikum Arnsberg, Karolinen Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Madrid
country: Spain
facility: University Hospital HM Monteprincipe
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: UNC Department of Surgery
name: William Marston, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vascular and Interventional Specialists of Orange County
name: Mahmood Razavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Razavi MK, Black S, Gagne P, Chiacchierini R, Nicolini P, Marston W; VIRTUS Investigators. Pivotal Study of Endovenous Stent Placement for Symptomatic Iliofemoral Venous Obstruction. Circ Cardiovasc Interv. 2019 Dec;12(12):e008268. doi: 10.1161/CIRCINTERVENTIONS.119.008268. Epub 2019 Dec 13.
citation: Razavi M, Marston W, Black S, Bentley D, Neglen P. The initial report on 1-year outcomes of the feasibility study of the VENITI VICI VENOUS STENT in symptomatic iliofemoral venous obstruction. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):192-200. doi: 10.1016/j.jvsv.2017.10.014. Epub 2017 Dec 28.