Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Covidien Identifier:
First received: September 14, 2007
Last updated: November 5, 2013
Last verified: November 2013

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.

Condition Intervention Phase
Carotid Artery Disease
Device: PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

Resource links provided by NLM:

Further study details as provided by Covidien:

Primary Outcome Measures:
  • Composite rate of death, ipsilateral CVA, procedure-related CVA, or myocardial infarction (MI) at 30 days post-procedure. [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3500
Study Start Date: May 2007
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Device: PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device
Carotid artery stenting with distal embolic protection.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00530504

United States, New York
Stony Brook University Hospital
Stony Brook, New York, United States
United States, Tennessee
Wellmont Medical Center
Kingsport, Tennessee, United States
Sponsors and Collaborators
Principal Investigator: Gary Ansel, MD MidWest Cardiology Research Foundation
Principal Investigator: Robert Safian, MD William Beaumont Hospitals
  More Information

Additional Information:
No publications provided

Responsible Party: Covidien Identifier: NCT00530504     History of Changes
Other Study ID Numbers: P-2611
Study First Received: September 14, 2007
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Covidien:
Carotid Artery Disease
Embolic Protection

Additional relevant MeSH terms:
Carotid Artery Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases processed this record on March 01, 2015