CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
VIVASURE CLOSURE DEVICE™device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01943344
NCT01943344N/ACompleted
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Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER I Study

Vivasure Medical Limited·interventional·Posted Sep 16, 2013·Updated Nov 2, 2018

In Brief

A clinical study evaluating VIVASURE CLOSURE DEVICE™ for Percutaneous Closure of Arteriotomy in Common Femoral Artery. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPercutaneous Closure of Arteriotomy in Common Femoral Artery
CountriesIreland
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 16, 2013
Enrollment StartJul 1, 2013
Primary CompletionJul 1, 2014
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 12.8 years ago

Interventions

VIVASURE CLOSURE DEVICE™device

implantation of VIVASURE CLOSURE DEVICE™