BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease

Completed · Not applicable

Conditions studied: May-Thurner Syndrome, Peripheral Vascular Disease, Venous Disease, Iliofemoral Occlusive Disease

In brief

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.

Key facts

Study ID

NCT02655887

Run by

C. R. Bard

People needed

170

Starts

2016-06-15

Expected to finish

2020-10-30

Last updated by the study team

2021-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject provides written informed consent using an Informed Consent Form approved by Ethics Committee/ Institutional Review Board for the site.
• Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
• 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.
• The subject has symptomatic (non-malignant) venous outflow obstruction in iliofemoral "venous segments".
• 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).
• The subject is able and willing to comply with any required medication regimen.
• The reference vessel diameters are between 7mm and 19 mm.

You may not qualify if…

• 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.
• Subject is or plans to become pregnant during the study.
• 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.
• The subject is asymptomatic, has a CEAP "C" <3, or a VCSS pain score of <2.
• The subject has a venous obstruction that extends into the inferior vena cava (IVC) or below the level of the lesser trochanter.
• The subject has a known uncorrectable bleeding diathesis or active coagulopathy.
• 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
• The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
• The subject has any planned surgical interventions within 30 days prior to, or within 30 days after the planned study procedure.
• The subject has a lesion or occlusion which cannot be traversed with a guidewire.
• The subject has had prior stenting in the target vessel.
• The subject has iliofemoral venous segments unsuitable for treatment with available sizes of study devices.
• 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.
• The subject is currently participating in an investigational drug, biologic, or another device study.
• The subject is currently on dialysis or has a serum creatinine ≥2.5mg/dl.

Where it is running

• Vascular Breakthroughs, LLC — Darien, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States
• Metro Health Hospital — Wyoming, Michigan, United States
• Cox Medical Centers — Springfield, Missouri, United States
• Mount Sinai Medical Center — New York, New York, United States
• North Carolina Heart and Vascular — Raleigh, North Carolina, United States
• Cardiothoracic and Vascular Surgeons — Austin, Texas, United States
• Centra Health, Inc., dba Stroobants Cardiovascular Center — Lynchburg, Virginia, United States
• Sentara Medical Group — Virginia Beach, Virginia, United States
• Lake Washington Vascular, PLLC — Bellevue, Washington, United States
• CAMC Health Education and Research Institute — Charleston, West Virginia, United States
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• JMLS Medical Services PTY LTDT/A PERTH INST. of VASCULAR RESEARCH — Perth, Western Australia, Australia
• Uniklinik RWTH — Aachen, Germany
• Klinikum Arnberg — Arnsberg, Germany
• Universitaets-Herrzentrum Freiburg-Bad Krozingen — Bad Krozingen, Germany
• University Hospital Galway — Galway, Ireland
• MUMC Maastricht — Maastricht, Netherlands
• Fundacion de investigacion HM Hospitales — Madrid, Spain
• Guy's & St. Thomas' Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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