CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,500 enrolled
Drug / intervention
PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Devicedevice
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/NCT00530504
NCT00530504N/ACompleted
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Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

Medtronic Endovascular·interventional·Posted Sep 17, 2007·Updated Mar 5, 2019

In Brief

A clinical study evaluating PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device for Carotid Artery Disease. Completed, enrolled 1,500 participants across 2 sites.

Detailed Summary

The purposes of this study are: 1. To provide additional safety and effectiveness information on the commercial use of Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection Device. 2. To evaluate rare and unanticipated adverse events. 3. To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarotid Artery Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 17, 2007
Enrollment StartMay 1, 2007
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 18.8 years ago

Interventions

PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Devicedevice

Carotid artery stenting with distal embolic protection.