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

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ClinicalTrials.gov Identifier: NCT00530504
Recruitment Status : Completed
First Posted : September 17, 2007
Results First Posted : September 16, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Brief Summary:

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 or disease Intervention/treatment Phase
Carotid Artery Disease Device: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
Study Start Date : May 2007
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention Device: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device
Carotid artery stenting with distal embolic protection.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530504


Locations
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
Medtronic Endovascular
Investigators
Principal Investigator: Gary Ansel, MD MidWest Cardiology Research Foundation
Principal Investigator: Robert Safian, MD William Beaumont Hospitals

Additional Information:
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00530504     History of Changes
Other Study ID Numbers: P-2611
First Posted: September 17, 2007    Key Record Dates
Results First Posted: September 16, 2015
Last Update Posted: October 16, 2015
Last Verified: August 2015

Keywords provided by Medtronic Endovascular:
Carotid Artery Disease
Embolic Protection

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases