This trial is active, not recruiting.

Condition carotid artery disease
Treatment protÉgÉ® gps™ and protÉgÉ® rx carotid stent systems and spiderfx™ embolic protection device
Phase phase 4
Sponsor Covidien
Start date May 2007
End date January 2015
Trial size 3500 participants
Trial identifier NCT00530504, P-2611


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
protÉgÉ® gps™ and protÉgÉ® rx carotid stent systems and spiderfx™ embolic protection device
Carotid artery stenting with distal embolic protection.

Primary Outcomes

Composite rate of death, ipsilateral CVA, procedure-related CVA, or myocardial infarction (MI) at 30 days post-procedure.
time frame: 30 Days

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
Principal investigator Gary Ansel, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Covidien.