Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

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.

Completed

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Key information

Conditions

Carotid Artery Disease Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University Hospital, Stony Brook, New York, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.

Sponsors and collaborators

Lead sponsor

Medtronic Endovascular

Industry

Registry information

Acronym: CREATE PAS

Important dates

Study start: 2007
Primary completion: 2014
Study completion: 2014
First posted: Sep 17, 2007
Registry last updated: Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed