Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

Completed · Not applicable

Conditions studied: Carotid Artery Disease

In brief

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.

Key facts

Study ID

NCT00530504

Run by

Medtronic Endovascular

People needed

1500

Starts

2007-05-01

Expected to finish

2014-01-01

Last updated by the study team

2019-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Subjects with contraindications as outlined in the Instructions for Use

Where it is running

• Stony Brook University Hospital — Stony Brook, New York, United States
• Wellmont Medical Center — Kingsport, Tennessee, United States

Full record on ClinicalTrials.gov

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