18 to 24 F Percutaneous Femoral Arteriotomy Closure Clinical Trial
Official title:
Clinical Investigation Plan (CIP) for Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER III Study
The purpose of this Clinical Investigation is to validate that the clinical use of the
VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm
its performance to percutaneously close femoral arterial puncture sites in the range of 18-24
F, post endovascular procedures.
This is a non-inferiority study based on safety. Safety will be assessed by incidence and
severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE up to 3
months from implantation is no worse than those associated with cut-down and sutured close.
This study will be a prospective, multi-centred, non-randomized study to investigate the
safety and performance of the VIVASURE CLOSURE DEVICE. The study shall not be blinded prior
to, during or post the procedure. All patients undergoing a procedure requiring an
arteriotomy in the range of 18 to 24 F, via the common femoral artery will be screened
against the inclusion/exclusion criteria. If the patient meets the requirements of the
clinical investigation, they shall be invited to participate, provide informed consent and
shall subsequently be assigned a subject number.
All subjects shall have an immediately post procedure, 24 hour, 1, 3 and 12 month follow-up
assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring
Committee.
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