Frontier II
Research type
Research Study
Full title
Clinical Investigation Plan (CIP) for Safety and Performance Study of Large Hole Vascular Closure Device – FRONTIER II study
IRAS ID
159948
Contact name
Gerard Brett
Contact email
Sponsor organisation
Vivasure Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 11 days
Research summary
This study is to assess the safety of a vascular closure device namely the VIVASURE CLOSURE DEVICE ™. The vascular closure device comprises a delivery system and absorbable implant, intended to seal the puncture hole that the doctor makes in the femoral artery during a scheduled procedure such as a heart valve replacement via a catheter. The vascular closure device shall be implanted in the femoral artery to seal the puncture hole once the scheduled procedure is complete. The implant from the vascular closure device is absorbable; this means that the implant in the artery that forms the seal will slowly degrade and disappear once the artery has healed. The implant will be completely absorbed in approximately 180 days.
This study is to investigate the safety and performance of the VIVASURE CLOSURE DEVICE™. Patients undergoing a large hole puncture procedure of 18-24F (diameter 6 – 8 mm) (arteriotomy size) via the common femoral artery will be screened against the study inclusion/exclusion criteria. If the patient meets the criteria of the clinical investigation, they shall be invited to participate. The patient will be required to provide informed consent for the procedure and when enrolled, will be assigned a unique number identifier.
Closures will be performed by study appointed investigators- the Interventionalist or the Vascular Surgeon. The closure will be percutaneous (via a small incision in the skin).
Each centre will enrol subjects until a minimum of 51 closures have been entered into the study. During cases where large hole puncture is required from both legs, data from surgical closures (cut down and sutured close) of the opposite limb will be recorded.
All subjects shall have an immediately post procedure, prior to discharge, 1, 3 and 12 month follow-up assessment. Safety data from the follow-ups will be assessed by an independent Data Safety Monitoring Committee.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/1260
Date of REC Opinion
29 Jan 2015
REC opinion
Further Information Favourable Opinion