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Safety and Performance Study of Large Hole Vascular Closure Device

NCT01943344 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-11-02

Study results available
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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.

Conditions

  • Percutaneous Closure of Arteriotomy in Common Femoral Artery

Interventions

DEVICE

VIVASURE CLOSURE DEVICE™

implantation of VIVASURE CLOSURE DEVICE™

Sponsors & Collaborators

  • Vivasure Medical Limited

    lead INDUSTRY

Principal Investigators

  • Dr Peter Crean, FRCPI MB ChB · St Jame's Hospital, Dublin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-07-31
Completion
2015-05-31

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01943344 on ClinicalTrials.gov