Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study | NCT00530504 | Trialant
CompletedInterventionalNot ApplicableUpdated Mar 5, 2019
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
ClinicalTrials.gov ID
NCT00530504
Lead Sponsor
Medtronic EndovascularINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
1,500Actual
Last Update Posted
Mar 5, 2019Actual
Start Date
May 2007
Primary Completion Date
Jan 2014Actual
Completion Date
Jan 2014Actual
Official Title
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
Brief Summary
The purposes of this study are:
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.
To evaluate rare and unanticipated adverse events.
To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.
Carotid Artery Disease
PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years and above
Informed consent
Intent to use the PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX and SpiderFX™ to treat carotid artery disease per Instructions for Use
Meet Instruction for Use (IFU)/ Centers for Medicare & Medicaid Services (CMS)defined anatomical or clinical high risk criteria
Exclusion Criteria:
Subjects with contraindications as outlined in the Instructions for Use