CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
PerQseal®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/NCT03423602
NCT03423602N/ACompleted
CompareCT.gov

Clinical Investigation Plan (CIP) for Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER IV Study

Vivasure Medical Limited·interventional·Posted Feb 6, 2018·Updated Feb 1, 2023

In Brief

A clinical study evaluating PerQseal® for Percutaneous CFA Arteriotomy Closure. Completed, enrolled 75 participants across 11 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPercutaneous CFA Arteriotomy Closure
CountriesGermany, Ireland
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 6, 2018
Enrollment StartOct 12, 2017
Primary CompletionNov 19, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.4 years ago

Interventions

PerQseal®device

Large hole closure system