CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Carotid Artery Stentprocedure
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/NCT01783639
NCT01783639N/ACompleted

The WISE Study is a Pivotal Study Evaluating the Safety and Performance of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting

Gardia Medical·interventional·Posted Feb 5, 2013·Updated Aug 7, 2017

In Brief

A clinical study evaluating Carotid Artery Stent for Carotid Artery Diseases and Stroke. Completed, enrolled 120 participants across 10 sites in 3 countries.

Detailed Summary

The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous US IDE carotid stenting with embolic protection studies

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Germany, Italy
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 5, 2013
Enrollment StartFeb 1, 2013
Primary CompletionDec 1, 2013
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.4 years ago

Interventions

Carotid Artery Stentprocedure

Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices