Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study (CREATE PAS)

Medtronic

Status: Completed

Conditions: Carotid Artery Disease

Treatments: Device: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00530504

P-2611

Details and patient eligibility

About

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.

Enrollment: 1,500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,500 participants in 1 patient group

Device

Experimental group

Description:

Device

Treatment:

Device: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device