Chronic Venous DisorderVIRTUSNCT02112877

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

A study testing Veniti Vici™ Venous Stent System in people with Chronic Venous Disorder and Venous Outflow Obstruction, run by Boston Scientific Corporation at 24 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Venous Disorder, Venous Outflow Obstruction, Symptomatic Venous Outflow Obstruction of Iliofemoral Vein
What is being tested?: Veniti Vici™ Venous Stent System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 24 sitesin 7 countries
Study dates: 26 Jun 2014to 18 Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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:

Show all 20Show fewer

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.]
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.

Trial locations and contacts

24 sites in 7 countries.

Country

City, postcode or hospital

24 sites in 7 countries

United States16 sites

The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Vascular Breakthroughs
Darien, Connecticut, 06820
Midwest Cardiovascular Foundation
Davenport, Iowa, 52803
Dr. Ediberto Soto-Cora
El Paso, Texas, 79925
Radiology Imaging Associates
Englewood, Colorado, 80112
Michigan Vascular Center
Flint, Michigan, 48507
Imperial Health, LLP
Lake Charles, Louisiana, 70601
Arkansas Site Management Services, LLC
Little Rock, Arkansas, 72211
NYU School of Medicine
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
New York Presbyterian Hospital/Cornell University
New York, New York, 10065
Sentara Vascular Specialists
Norfolk, Virginia, 23507
St. Joseph Hospital
Orange, California, 92868
Abrazo Arizona Heart Hospital
Phoenix, Arizona, 85016
Healthfinity PLCC
Scottsdale, Arizona, 85254
University of Washington Medical Center
Seattle, Washington, 98195

Other trials in United States

France2 sites

Infermerierie Protestante de Lyon
Décines-Charpieu
Hôpital Nord de Marseille
Marsaille

Other trials in France

United Kingdom2 sites

Guy's and St Thomas' NHS Foundation Trust
London
University College London
London

Other trials in United Kingdom

Germany1 site

Klinikum Arnsberg, Karolinen Hospital
Arnsberg

Other trials in Germany

Ireland1 site

University Hospital Galway
Galway

Other trials in Ireland

Netherlands1 site

Rijnstate Ziekenhuis
Arnhem

Other trials in Netherlands

Spain1 site

University Hospital HM Monteprincipe
Madrid

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions: Chronic Venous Disorder, Venous Outflow Obstruction, Symptomatic Venous Outflow Obstruction of Iliofemoral Vein
Being tested: Veniti Vici™ Venous Stent System
Keywords: iliofemoral vein, venous, venous obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Veniti Vici™ Venous Stent SystemDevice

Study groups in NCT02112877
Study group	Role	What they receive
VICI Stent Implantation - Feasibility	Experimental	Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System Receives: Device: Veniti Vici™ Venous Stent System
VICI Stent Implantation - Pivotal	Experimental	Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System Receives: Device: Veniti Vici™ Venous Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 days
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.
Measured: 12 months post-intervention

Secondary outcomes (1)

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).
Measured: 12 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 201418 Dec 2020

First posted14 Apr 2014 (estimated)
Study start26 Jun 2014
Primary completion5 Dec 2017
Study completion18 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Chronic Venous DisorderStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
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.
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02112877
Sponsor's protocol ID: STE-HUM-004P
Other IDs: STE-HUM-007P
Acronym: VIRTUS
Status last verified: Mar 2021
First submitted: 10 Apr 2014
Last updated: 15 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated device: Yes

Publications

Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
PubMed 39968829
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.
PubMed 31833414
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.
PubMed 29290601

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02112877
Acronym / sponsor ID: VIRTUS / STE-HUM-004P
Conditions: Chronic Venous Disorder, Venous Outflow Obstruction, Symptomatic Venous Outflow Obstruction of Iliofemoral Vein
Keywords: iliofemoral vein, venous, venous obstruction
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 26 Jun 2014 (actual)
Primary completion: 5 Dec 2017 (actual)
Study completion: 18 Dec 2020 (actual)
First posted: 14 Apr 2014 (estimated)
Results: Posted 30 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
VICI Stent Implantation - Feasibility	Experimental	Device: Veniti Vici™ Venous Stent SystemPercutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
VICI Stent Implantation - Pivotal	Experimental	Device: Veniti Vici™ Venous Stent SystemPercutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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:

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Veniti Vici™ Venous Stent System	Device	VICI Stent Implantation - Feasibility, VICI Stent Implantation - Pivotal

Primary outcome

Number of Participants With 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.
Percentage of Participants That Demonstrated 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.

1 secondary outcome

Number of Participants With Improvement in Venous Clinical Severity Score (VCSS)
Time frame: 12 months post-intervention

Results and safety

Results posted to the registry on 30 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VICI Stent Implantation - Feasibility	30	28
VICI Stent Implantation - Pivotal	170	157

Primary outcome: Number of Participants With Major Adverse Events (MAE)

Time frame: 30 days. Count of participants. Unit: Participants

Measure	VICI Stent Implantation - Feasibility n = 30	VICI Stent Implantation - Pivotal n = 169
Device or procedure-related death	0	0
Device or procedure-related bleeding	0	0
Device or procedure-related arterial/venous injury	2	2
Device or procedure-related acuteDeepVeinThrombus	0	0
Clinically significant pulmonary embolism	0	0
Embolization of the stent	0	0

Population analysed: For the pivotal cohort, one subject never returned for follow-up after discharge.

Primary outcome: Percentage of Participants That Demonstrated Primary Patency

Time frame: 12 months post-intervention. Number. Unit: Percentage of Participants

Measure	VICI Stent Implantation - Feasibility n = 22	VICI Stent Implantation - Pivotal n = 170
Value	77.3	84.0

Population analysed: For the feasibility cohort, month 12 outcomes were available for 22 subjects. For the pivotal cohort, month 12 outcomes were available for 125 subjects. Those without venography performed at 12 months had their result assigned by random selection from subjects with a venogram result who had the same anatomy and the same DUS outcome (if available).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VICI Stent Implantation - Feasibility	14 of 30 (46.7%)	14 of 30 (46.7%)	0 of 30
VICI Stent Implantation - Pivotal	86 of 170 (50.6%)	102 of 170 (60%)	4 of 170

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39968829Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
Derived from this study: PubMed 31833414Razavi 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.
Derived from this study: PubMed 29290601Razavi 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Marston, MD principal investigator

UNC Department of Surgery

Mahmood Razavi, MD principal investigator

Vascular and Interventional Specialists of Orange County

24 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Veniti Vici™ Venous Stent System in people with Chronic Venous Disorder and Venous Outflow Obstruction, run by Boston Scientific Corporation at 24 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, France, United Kingdom, Germany, Ireland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Major Adverse Events (MAE) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02112877, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.