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Safety and Performance Study of Large Hole Vascular Closure Device

NCT02788448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-02-01

No results posted yet for this study

Summary

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.

Conditions

  • 18 to 24 F Percutaneous Femoral Arteriotomy Closure

Interventions

DEVICE

VIVASURE CLOSURE DEVICE

Large hole closure device

Sponsors & Collaborators

  • Vivasure Medical Limited

    lead INDUSTRY

Principal Investigators

  • Prof. Dr. med Giovanni Torsello, MD · St Fraziskus Hospital, Muenster, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-03-31
Completion
2017-11-30

Countries

  • Germany

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 NCT02788448 on ClinicalTrials.gov