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

Chronic Venous Disorder Clinical Trial

— VIRTUS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02112877
• Other study ID #: STE-HUM-004P
• Secondary ID: STE-HUM-007P
• Status: Completed
• Phase: N/A
• Start date: June 26, 2014
• Est. completion date: December 18, 2020

Study information

• Verified date: March 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 18, 2020
• Est. primary completion date: December 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Venous Disorder
• Symptomatic Venous Outflow Obstruction of Iliofemoral Vein
• Venous Outflow Obstruction

Intervention

Device:
• Veniti Vici™ Venous Stent System

Locations

Country	Name	City	State
France	Infermerierie Protestante de Lyon	Decines Charpieu
France	Hôpital Nord de Marseille	Marsaille
Germany	Klinikum Arnsberg, Karolinen Hospital	Arnsberg
Ireland	University Hospital Galway	Galway
Netherlands	Rijnstate Ziekenhuis	Arnhem
Spain	University Hospital HM Monteprincipe	Madrid
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	University College London	London
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Vascular Breakthroughs	Darien	Connecticut
United States	Midwest Cardiovascular Foundation	Davenport	Iowa
United States	Dr. Ediberto Soto-Cora	El Paso	Texas
United States	Radiology Imaging Associates	Englewood	Colorado
United States	Michigan Vascular Center	Flint	Michigan
United States	Imperial Health, LLP	Lake Charles	Louisiana
United States	Arkansas Site Management Services, LLC	Little Rock	Arkansas
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	New York Presbyterian Hospital/Cornell University	New York	New York
United States	NYU School of Medicine	New York	New York
United States	Sentara Vascular Specialists	Norfolk	Virginia
United States	St. Joseph Hospital	Orange	California
United States	Abrazo Arizona Heart Hospital	Phoenix	Arizona
United States	Healthfinity PLCC	Scottsdale	Arizona
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  France,  Germany,  Ireland,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Procedural Technical Success	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.	During Procedure
Other	Number of Participants With Lesion Success	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).	During Procedure
Other	Number of Participants With Procedural Success	Procedural success is defined as procedural technical success without the occurrence of a major adverse event (MAE) between the index procedure and discharge.	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)
Other	Number of Participants With Late Technical Success	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 .	12 months post-intervention
Other	Change in the Quality of Life (Chronic Venous Insufficiency Questionnaire)(CIVIQ2))	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.	Baseline and 12 months post-intervention
Other	Number of Participants With Estimated Primary-Assisted Patency	Primary-assisted patency is defined as freedom from occlusion regardless of whether an intervention (subsequent to the index procedure) was performed.	12 months post-intervention
Other	Number of Participants With Estimated Secondary Patency	Secondary patency is defined as freedom from "permanent" loss of patency determined through last follow-up (irrespective of the number of interventions).	36 months post-intervention
Primary	Number of Participants With Major Adverse Events (MAE)	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.	30 days
Primary	Percentage of Participants That Demonstrated Primary Patency	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.	12 months post-intervention
Secondary	Number of Participants With Improvement in Venous Clinical Severity Score (VCSS)	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).	12 months post-intervention