Symptomatic Venous Outflow Obstruction in the Iliofemoral VeinNCT01970007

VIVO Clinical Study

A study testing Zilver Vena Venous Self-Expanding Stent in people with Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein, run by Cook Research Incorporated at 30 sites in 2 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

The purpose of the VIVO Clinical Study is to evaluate the safety and effectiveness of the Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein
What is being tested?: Zilver Vena Venous Self-Expanding Stent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 243 participants
Where: 30 sitesin 2 countries
Study dates: 13 Dec 2013to 20 Nov 2019
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

symptomatic venous outflow obstruction in one iliofemoral venous segment (i.e., one limb) per patient, demonstrated by:
CEAP "C" ≥ 3, or
VCSS pain score ≥ 2

Who cannot join

< 18 years of age;
pregnant or planning to become pregnant in the next 12 months;
planned surgical or interventional procedures of the target limb (except thrombolysis and/or thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in patients at high risk for pulmonary embolism) within 30 days prior to or any time after the study procedure;
planned surgical or interventional procedures for other medical conditions (i.e., not associated with the target limb) within 30 days prior to or after the study procedure;
lesions with intended treatment lengths extending into the inferior vena cava or below the level of the lesser trochanter;
lesion with malignant obstruction;
previous stenting of the target vessel;
iliofemoral venous segment unsuitable for treatment with available sizes of study devices.

Trial locations and contacts

30 sites in 2 countries.

Country

City, postcode or hospital

30 sites in 2 countries

United States29 sites

University of Michigan Health System
Ann Arbor, Michigan, 48109
Piedmont Hospital
Atlanta, Georgia, 30309
Cardiothoracic and Vascular Surgeons
Austin, Texas, 78756
University of Alabama Birmingham Hospital
Birmingham, Alabama, 35233
Medical University of South Carolina
Charleston, South Carolina, 29425
Carolinas Medical Center
Charlotte, North Carolina, 28203
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Arrowhead Hospital
Glendale, Arizona, 85308
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202
St. Vincent Medical Group
Indianapolis, Indiana, 46290
University of Iowa
Iowa City, Iowa, 52242
CHI Health St. Elizabeth
Lincoln, Nebraska, 68510
Littleton Adventist Hospital
Littleton, Colorado, 80122
University of Louisville - Norton Hospital
Louisville, Kentucky, 40202
Yale-New Haven Hospital
New Haven, Connecticut, 06510
New York University - Langone Medical Center
New York, New York, 10016
Christiana Care Health Systems
Newark, Delaware, 19718
Southern Connecticut Vascular Center - Norwalk Hospital
Norwalk, Connecticut, 06856
Temple University Hospital
Philadelphia, Pennsylvania, 19140
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Utah Valley Regional Medical Center
Provo, Utah, 84604
Rex Hospital
Raleigh, North Carolina, 27607
Shady Grove Adventist
Rockville, Maryland, 20850
Barnes Jewish Hospital Plaza
St Louis, Missouri, 63110
Mercy Hospital
St Louis, Missouri, 63141
Florida Pepin Heart Institute
Tampa, Florida, 33613
Holy Name Medical Center
Teaneck, New Jersey, 07666
ProMedica - Jobst Vascular Institute
Toledo, Ohio, 43606
Oklahoma State University Medical Center
Tulsa, Oklahoma, 74127

Other trials in United States

Taiwan1 site

Taipei Medical University Wan Fang Hospital
Taipei, 116

Other trials in Taiwan

About this study

Official title: Evaluation of the Zilver® Vena™ Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction

The purpose of the VIVO Clinical Study is to evaluate the safety and effectiveness of the Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.

Conditions: Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein
Being tested: Zilver Vena Venous Self-Expanding Stent
Keywords: venous, outflow obstruction, iliofemoral vein

What participants receive

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

Zilver Vena Venous Self-Expanding StentDevice
Also called venous stent
stenting

Study groups in NCT01970007
Study group	Role	What they receive
Zilver Vena Venous Self-Expanding Stent	Experimental	Not described Receives: Device: Zilver Vena Venous Self-Expanding Stent

What is being measured

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

Number of Participants With 30-day Freedom From Major Adverse Events
Major adverse events were defined as procedural bleeding requiring transfusion, procedure- or device-related death, clinically driven target lesion reintervention, clinical migration, new symptomatic PE, or procedure-related perforation requiring open surgical repair or flow-limiting dissection of the target vessel.
Measured: 30 days
The Rate of Participants With Primary Quantitative Patency at 12 Months
Primary quantitative patency was defined as a treated venous segment that retained (uninterrupted; intervention-free) an MLD (Minimum Lumen Diameter ) > 50% of the immediate post-procedure stented MLD as demonstrated by venography as determined by the core laboratory.
Measured: 12 months

Secondary outcomes (2)

Change From Baseline in the Venous Clinical Severity Score (VCSS) at 1 Month
Venous Clinical Severity Score (VCSS) is a method of classifying venous disease severity based on 10 clinical descriptors (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulcer, size of active ulcer, and use of compression therapy), each scored on a scale from 0 (Absent) to 3 (Severe). The VCSS score is the sum of the scores for the individual descriptors, ranging from 0 to 30.
Mean change = (1-month score - Baseline Score)
Measured: Baseline and 1 month
Change From Baseline in the Venous Clinical Severity Score (VCSS) at 12 Months
Venous Clinical Severity Score (VCSS) is a method of classifying venous disease severity based on 10 clinical descriptors (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulcer, size of active ulcer, and use of compression therapy), each scored on a scale from 0 (Absent) to 3 (Severe). The VCSS score is the sum of the scores for the individual descriptors, ranging from 0 to 30.
Mean change = (12-month score - Baseline Score)
Measured: Baseline and 12 months

Timeline

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

13 Dec 201320 Nov 2019

First posted25 Oct 2013 (estimated)
Study start13 Dec 2013
Primary completion20 Nov 2017
Study completion20 Nov 2019

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 (1)Papers the sponsor has linked to this study.
Other trials for Symptomatic Venous Outflow Obstruction in the Iliofemoral VeinStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 243 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01970007
Sponsor's protocol ID: 11-010
Status last verified: Mar 2021
First submitted: 22 Oct 2013
Last updated: 8 Apr 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

Hofmann LR, Gagne P, Brown JA, Saunders A, Comerota A; VIVO Study Investigators. Twelve-month end point results from the evaluation of the Zilver Vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction (VIVO clinical study). J Vasc Surg Venous Lymphat Disord. 2023 May;11(3):532-541.e4. doi: 10.1016/j.jvsv.2022.12.066. Epub 2023 Jan 13.
PubMed 36646383

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Zilver® Vena™ Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction
ClinicalTrials.gov ID: NCT01970007
Acronym / sponsor ID: 11-010
Conditions: Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein
Keywords: venous, outflow obstruction, iliofemoral vein
Study type: Interventional
Recruitment status: Completed
Enrolment: 243 participants (actual)
Lead sponsor: Cook Research IncorporatedIndustry (pharma, biotech, devices)
Study start: 13 Dec 2013 (actual)
Primary completion: 20 Nov 2017 (actual)
Study completion: 20 Nov 2019 (actual)
First posted: 25 Oct 2013 (estimated)
Results: Posted 8 Apr 2021

Clinical summary

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

The purpose of the VIVO Clinical Study is to evaluate the safety and effectiveness of the Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Zilver Vena Venous Self-Expanding Stent	Experimental	Device: Zilver Vena Venous Self-Expanding Stent

Who may qualify

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

Key inclusion criteria (3 listed)

symptomatic venous outflow obstruction in one iliofemoral venous segment (i.e., one limb) per patient, demonstrated by:

Key exclusion criteria (8 listed)

< 18 years of age;
pregnant or planning to become pregnant in the next 12 months;
planned surgical or interventional procedures of the target limb (except thrombolysis and/or thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in patients at high risk for pulmonary embolism) within 30 days prior to or any time after the study procedure;
planned surgical or interventional procedures for other medical conditions (i.e., not associated with the target limb) within 30 days prior to or after the study procedure;
lesions with intended treatment lengths extending into the inferior vena cava or below the level of the lesser trochanter;

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
Zilver Vena Venous Self-Expanding StentAlso: venous stentstenting	Device	Zilver Vena Venous Self-Expanding Stent

Primary outcome

Number of Participants With 30-day Freedom From Major Adverse Events
Time frame: 30 days
Major adverse events were defined as procedural bleeding requiring transfusion, procedure- or device-related death, clinically driven target lesion reintervention, clinical migration, new symptomatic PE, or procedure-related perforation requiring open surgical repair or flow-limiting dissection of the target vessel.
The Rate of Participants With Primary Quantitative Patency at 12 Months
Time frame: 12 months
Primary quantitative patency was defined as a treated venous segment that retained (uninterrupted; intervention-free) an MLD (Minimum Lumen Diameter ) > 50% of the immediate post-procedure stented MLD as demonstrated by venography as determined by the core laboratory.

2 secondary outcomes

Change From Baseline in the Venous Clinical Severity Score (VCSS) at 1 Month
Time frame: Baseline and 1 month
Change From Baseline in the Venous Clinical Severity Score (VCSS) at 12 Months
Time frame: Baseline and 12 months

Results and safety

Results posted to the registry on 8 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zilver Vena Venous Self-Expanding Stent	243	188

Primary outcome: Number of Participants With 30-day Freedom From Major Adverse Events

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

Measure	Zilver Vena Venous Self-Expanding Stent n = 240
Value	232

Zilver Vena Venous Self-Expanding Stent: Freedom from MAE rate (%): 96.7 (95% CI 93.5 to 98.6), p <0.0001, One-sided Exact binomial test

Population analysed: The study protocol specified the analysis be based on the intent-to-treat population, which includes all 243 enrolled patients. Among the 243 enrolled patients, data for the primary safety endpoint were available for 240 patients. Therefore, because the number of analyzable patients exceeded the minimum sample size required for sufficient statistical power (n=218), the primary analysis was based on the analyzable population in accordance with the study protocol.

Primary outcome: The Rate of Participants With Primary Quantitative Patency at 12 Months

Time frame: 12 months. Number. Unit: percentage of participants

Measure	Zilver Vena Venous Self-Expanding Stent n = 243
Value	89.9

Zilver Vena Venous Self-Expanding Stent: 12-month quantitative patency rate (%): 89.9 (95% CI 85.1 to 93.4), p <0.0001, Binomial test for one proportion

Population analysed: The study protocol specified the primary analysis be based on intent-to-treat population (n=243). Among the 243 enrolled patients, 189 patients had venographic primary patency outcome data available (i.e., post-procedure and 12-month venogram data). Therefore, the results presented are after the outcome was imputed multiple times by random sampling from the Bernoulli distribution based on outcomes for the analyzable patients (n=189) without covariate adjustment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zilver Vena Venous Stent	111 of 243 (45.7%)	84 of 243 (34.6%)	5 of 243

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36646383Hofmann LR, Gagne P, Brown JA, Saunders A, Comerota A; VIVO Study Investigators. Twelve-month end point results from the evaluation of the Zilver Vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction (VIVO clinical study). J Vasc Surg Venous Lymphat Disord. 2023 May;11(3):532-541.e4. doi: 10.1016/j.jvsv.2022.12.066. Epub 2023 Jan 13.

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.

Anthony J. Comerota, MD, FACS, FACC principal investigator

Inova Vascular

Lawrence "Rusty" Hofmann, MD principal investigator

Stanford University

30 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Zilver Vena Venous Self-Expanding Stent in people with Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein, run by Cook Research Incorporated at 30 sites in 2 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 3 inclusion and 8 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 8 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 30 sites in United States, Taiwan. 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 8 Apr 2021). 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 30-day Freedom From Major Adverse Events (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 NCT01970007, which also lists 1 linked publication.

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 8 Apr 2021.