Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial

Medtronic

Status and phase: Completed; Phase 3

Conditions: Carotid Artery Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00619775

P-1007

Details and patient eligibility

About

Evaluate the safety and efficacy of the Protege Stent and Spider Device in the treatment of common and/or internal carotid artery stenoses for subjects that are high risk for carotid endarterectomy.

Enrollment: 419 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years and above
• informed consent
• for female subjects, not pregnant or planning on becoming pregnant
• meet protocol defined anatomical or clinical high risk criteria

Exclusion criteria

• participation in another clincial study which may affect either the pre-procedure or follow-up results
• prior stenting of the ipsilateral carotid artery
• life expectancy less than twelve months
• known allergy or intolerance of study medications or device materials
• must not meet general or angiographic exclusion criteria as defined in the protocol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)