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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02655887




Registration number
NCT02655887
Ethics application status
Date submitted
7/01/2016
Date registered
14/01/2016

Titles & IDs
Public title
BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease
Scientific title
The BARD® VENOVO™ Venous Stent Study - A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease - an Assessment for Effectiveness and Safety (VERNACULAR)
Secondary ID [1] 0 0
BPV-14-007
Universal Trial Number (UTN)
Trial acronym
VERNACULAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
May-Thurner Syndrome 0 0
Peripheral Vascular Disease 0 0
Venous Disease 0 0
Iliofemoral Occlusive Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - VENOVO™ Venous Stent

Experimental: VENOVO™ Venous Stent. - Implant of the VENOVO™ Venous Stent


Treatment: Devices: VENOVO™ Venous Stent
VENOVO™ Venous stent placement
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Primary Patency of the Venous Stent at 12 Months Post-Index Procedure
Timepoint [1] 0 0
12 months post-index procedure
Primary outcome [2] 0 0
Number of Participants With Freedom From Major Adverse Events (MAEs)
Timepoint [2] 0 0
30 days post-index procedure
Secondary outcome [1] 0 0
Endpoint With Hypothesis Testing: Index of Venous Clinical Severity Score (VCSS) From Baseline to 12 Months
Timepoint [1] 0 0
Evaluation at 12 months post-index procedure
Secondary outcome [2] 0 0
Endpoint With Hypothesis Testing: Index of Quality of Life (QoL) From Baseline to 12 Months
Timepoint [2] 0 0
Evaluation at 12 months post-index procedure
Secondary outcome [3] 0 0
Endpoint Without Hypothesis Testing: Index of CEAP at 30 Days, 6 Months, and 12 Months Post Procedure
Timepoint [3] 0 0
Evaluation through 30 day, 6 months and 12 months post index procedure
Secondary outcome [4] 0 0
Endpoint Without Hypothesis Testing: Number of Participants With Acute Technical Success
Timepoint [4] 0 0
At time of Index Procedure
Secondary outcome [5] 0 0
Endpoint Without Hypothesis Testing: Number of Participants With Acute Procedure Success (ITT Subjects)
Timepoint [5] 0 0
Less than 30 days post index procedure
Secondary outcome [6] 0 0
Endpoint Without Hypothesis Testing: Number of Participants With Lesion Success (ITT Subjects)
Timepoint [6] 0 0
At the conclusion of index procedure
Secondary outcome [7] 0 0
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Lesion Revascularization (TLR) (ITT Subjects)
Timepoint [7] 0 0
Evaluation throrugh 30 day, 6 months and 12 months post index procedure
Secondary outcome [8] 0 0
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Vessel Revascularization (TVR) (ITT Subjects)
Timepoint [8] 0 0
Evaluation through 30 days, 6 months and 12 months post index procedure
Secondary outcome [9] 0 0
Endpoint Without Hypothesis Testing: Number of Participants Without Device Stent Fracture at 12 Months Follow-Up
Timepoint [9] 0 0
Evaluation at 12 months post-index procedure

Eligibility
Key inclusion criteria
1. The subject provides written informed consent using an Informed Consent Form approved by Ethics Committee/ Institutional Review Board for the site.
2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
3. The subject is a male or non-pregnant female = 18 years old with an expected lifespan sufficient to allow for completion of all study procedures.
4. The subject has symptomatic (non-malignant) venous outflow obstruction in iliofemoral "venous segments".
5. The subject has symptomatic venous outflow obstruction (non-malignant) in iliofemoral venous segments(Clinical-Etiology-Anatomic-Pathophysiologic (CEAP) "C" = 3 or VCSS pain score of = 2).
6. The subject is able and willing to comply with any required medication regimen.
7. The reference vessel diameters are between 7mm and 19 mm.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject is unable or unwilling to provide written informed consent, or is unable or unwilling to conform to the study protocol follow-up procedures and visits.
2. Subject is or plans to become pregnant during the study.
3. Subject has contralateral disease of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof and does not meet the venous outflow obstruction requirement or has a malignant obstruction.
4. The subject is asymptomatic, has a CEAP "C" <3, or a VCSS pain score of <2.
5. The subject has a venous obstruction that extends into the inferior vena cava (IVC) or below the level of the lesser trochanter.
6. The subject has a known uncorrectable bleeding diathesis or active coagulopathy.
7. The subject has a known allergy or sensitivity to Nickel or Titanium or intolerance to antiplatelet, anticoagulant or thrombolytic medications medications required per the protocol
8. The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
9. The subject has any planned surgical interventions within 30 days prior to, or within 30 days after the planned study procedure.
10. The subject has a lesion or occlusion which cannot be traversed with a guidewire.
11. The subject has had prior stenting in the target vessel.
12. The subject has iliofemoral venous segments unsuitable for treatment with available sizes of study devices.
13. The subject has another medical condition, which may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow completion of study procedures and follow ups.
14. The subject is currently participating in an investigational drug, biologic, or another device study.
15. The subject is currently on dialysis or has a serum creatinine =2.5mg/dl.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/10/2020
Sample size
Target
Accrual to date
Final
170
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
JMLS Medical Services PTY LTDT/A PERTH INST. of VASCULAR RESEARCH - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
United States of America
State/province [10] 0 0
West Virginia
Country [11] 0 0
Germany
State/province [11] 0 0
Aachen
Country [12] 0 0
Germany
State/province [12] 0 0
Arnsberg
Country [13] 0 0
Germany
State/province [13] 0 0
Bad Krozingen
Country [14] 0 0
Ireland
State/province [14] 0 0
Gaillimh
Country [15] 0 0
Netherlands
State/province [15] 0 0
Maastricht
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
C. R. Bard
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Dake, MD
Address 0 0
Lead Principal Investigator
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02655887