Safety and Performance Study of Large Hole Vascular Closure Device — FRONTIER-I  

Percutaneous Closure of Arteriotomy in Common Femoral Artery Clinical Trial

Official title: Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER I Study

Status Completed

Clinical Trial Summary

The purpose of this Clinical Investigation is to gather feasibility data on the clinical use of the VIVASURE CLOSURE DEVICE™ in relation to safety, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures.

Clinical Trial Description

This study will be a prospective, multi-centred, non-randomized pilot study to investigate the safety and performance of the VIVASURE CLOSURE DEVICE™. 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.

Patient safety will be monitored closely by the Data Safety Monitoring Committee (DSMC). Safety data will be reported to the DSMC for every patient with a reported complication. The DSMC will adjudicate on the safety data to determine whether it is safe to continue enrolment.

Subjects shall have a 1, 3 and 12 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee.

This protocol will adopt the VARC-2 definitions for major vascular complication associated with closure of the access site.

This pilot study will enrol approximately 10 subjects. The study is designed to support a larger CE Mark study. As such, a study safety assessment will be complete when all patients have completed their 1 month follow-up assessment. The Data Safety Monitoring Committee (DSMC) will review all complications and recommend whether it is safe to proceed to the CE Mark study. All patients will continue to be followed at 1, 3 and 12 month follow-ups. ;

Related Conditions & MeSH terms

• Percutaneous Closure of Arteriotomy in Common Femoral Artery

• NCT number: NCT01943344
• Study type: Interventional
• Source: Vivasure Medical Limited
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Completion date: May 2015