Clinical trial NCT02655887: BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: May-Thurner Syndrome
Peripheral Vascular Disease
Venous Disease
Iliofemoral Occlusive Disease
Keywords: Vernacular
Iliofemoral Occlusive Disease
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2016-01-14
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The BARD® Venovo™ Venous Stent Study is a non-randomized clinical study intended to collect confirmatory evidence of the safety and effectiveness of the Venous Stent for the treatment of iliofemoral occlusive disease.

Detailed description: This is a prospective, multi-center, non-randomized, single-arm clinical study of the VENOVO ™ Venous Stent for the treatment of iliofemoral occlusive disease. The study will be conducted at a maximum of 35 investigational sites ("sites") in the United States, and Europe and Australia/New Zealand. Enrollment will continue until a maximum of one hundred seventy (170) subjects are treated with the VENOVO™ Venous Stent, which is an estimated three-hundred forty (340) consecutive subjects in a non-randomized fashion. It is assumed that approximately 50% of the treated subjects will be U.S. subjects. Clinical follow-up for all treated subjects will be performed at hospital discharge, 30-days, and 6-, 12-, 24-, and 36-months post-index procedure.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Number of Participants With Primary Patency of the Venous Stent at 12 Months Post-Index Procedure
timeFrame: 12 months post-index procedure
measure: Number of Participants With Freedom From Major Adverse Events (MAEs)
timeFrame: 30 days post-index procedure
Secondary outcomes:
measure: Endpoint With Hypothesis Testing: Index of Venous Clinical Severity Score (VCSS) From Baseline to 12 Months
timeFrame: Evaluation at 12 months post-index procedure
measure: Endpoint With Hypothesis Testing: Index of Quality of Life (QoL) From Baseline to 12 Months
timeFrame: Evaluation at 12 months post-index procedure
measure: Endpoint Without Hypothesis Testing: Index of CEAP at 30 Days, 6 Months, and 12 Months Post Procedure
timeFrame: Evaluation through 30 day, 6 months and 12 months post index procedure
measure: Endpoint Without Hypothesis Testing: Number of Participants With Acute Technical Success
timeFrame: At time of Index Procedure
measure: Endpoint Without Hypothesis Testing: Number of Participants With Acute Procedure Success (ITT Subjects)
timeFrame: Less than 30 days post index procedure
measure: Endpoint Without Hypothesis Testing: Number of Participants With Lesion Success (ITT Subjects)
timeFrame: At the conclusion of index procedure
measure: Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Lesion Revascularization (TLR) (ITT Subjects)
timeFrame: Evaluation throrugh 30 day, 6 months and 12 months post index procedure
measure: Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Vessel Revascularization (TVR) (ITT Subjects)
timeFrame: Evaluation through 30 days, 6 months and 12 months post index procedure
measure: Endpoint Without Hypothesis Testing: Number of Participants Without Device Stent Fracture at 12 Months Follow-Up
timeFrame: Evaluation at 12 months post-index procedure
Other outcomes:
Locations:
city: Darien
country: United States
facility: Vascular Breakthroughs, LLC
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Springfield
country: United States
facility: Cox Medical Centers
state: Missouri
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Raleigh
country: United States
facility: North Carolina Heart and Vascular
state: North Carolina
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons
state: Texas
city: Lynchburg
country: United States
facility: Centra Health, Inc., dba Stroobants Cardiovascular Center
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Medical Group
state: Virginia
city: Bellevue
country: United States
facility: Lake Washington Vascular, PLLC
state: Washington
city: Charleston
country: United States
facility: CAMC Health Education and Research Institute
state: West Virginia
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Perth
country: Australia
facility: JMLS Medical Services PTY LTDT/A PERTH INST. of VASCULAR RESEARCH
state: Western Australia
city: Aachen
country: Germany
facility: Uniklinik RWTH
city: Arnsberg
country: Germany
facility: Klinikum Arnberg
city: Bad Krozingen
country: Germany
facility: Universitaets-Herrzentrum Freiburg-Bad Krozingen
city: Gaillimh
country: Ireland
facility: University Hospital Galway
city: Maastricht
country: Netherlands
facility: MUMC Maastricht
city: Madrid
country: Spain
facility: Fundacion de investigacion HM Hospitales
city: London
country: United Kingdom
facility: Guy's & St. Thomas' Hospital
Study officials:
affiliation: Lead Principal Investigator
name: Michael Dake, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dake MD, O'Sullivan G, Shammas NW, Lichtenberg M, Mwipatayi BP, Settlage RA; VERNACULAR Trial Investigators. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol. 2021 Dec;44(12):1918-1929. doi: 10.1007/s00270-021-02975-2. Epub 2021 Sep 20.