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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Large hole closure device
The Charité - Universitätsmedizin
Berlin, Germany
University Hospital Leipzig
Leipzig, Germany
St Franziskus Hospital
Münster, Germany
Major vascular complications [Safety]
Incidence of major vascular complications directly related to study Device (as defined by VARC-2)
Time frame: up to 3 Months
Minor vascular complications [Safety]
Incidence of minor vascular complications directly related to the study Device (as defined by VARC-2)
Time frame: up to 3 Months
Study device technical success rate [Performance]
Technical success rate for the study Device (percentage of subjects not requiring alternative therapy to achieve haemostasis)
Time frame: within 24 hours
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