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Safety and Performance Study of Large Hole Vascular Closure Device FIV

NCT03423602 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-02-01

Study results available
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Summary

The purpose of this Clinical Investigation Plan (CIP) is to:

1. Confirm the safety and performance of the PerQseal® large hole closure system.
2. To expand its indications of use to include common femoral arteriotomies created with 12 to 20 F sheaths in patients undergoing endovascular procedures.

Conditions

  • Percutaneous CFA Arteriotomy Closure

Interventions

DEVICE

PerQseal®

Large hole closure system

Sponsors & Collaborators

  • Vivasure Medical Limited

    lead INDUSTRY

Principal Investigators

  • Dr Arne Schwindt · St Fraziskus Hospital, Muenster, Germany

  • Dr Christoph Naber · Contilia Heart and Vascular centre, Essen, 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
2017-10-12
Primary Completion
2019-11-19
Completion
2019-11-19

Countries

  • Germany
  • 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 NCT03423602 on ClinicalTrials.gov