search
Back to results

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

Primary Purpose

Carotid Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device
Sponsored by
Medtronic Endovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Disease focused on measuring Carotid Artery Disease, Embolic Protection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stony Brook University Hospital
  • Wellmont Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device

Arm Description

Device

Outcomes

Primary Outcome Measures

Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.
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.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2007
Last Updated
February 14, 2019
Sponsor
Medtronic Endovascular
search

1. Study Identification

Unique Protocol Identification Number
NCT00530504
Brief Title
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
Acronym
CREATE PAS
Official Title
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purposes of this study are: 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. To evaluate rare and unanticipated adverse events. To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Disease
Keywords
Carotid Artery Disease, Embolic Protection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device
Arm Type
Experimental
Arm Description
Device
Intervention Type
Device
Intervention Name(s)
PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device
Intervention Description
Carotid artery stenting with distal embolic protection.
Primary Outcome Measure Information:
Title
Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.
Description
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.
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Ansel, MD
Organizational Affiliation
MidWest Cardiology Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Safian, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
Wellmont Medical Center
City
Kingsport
State/Province
Tennessee
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ev3.net
Description
Click here for information on ev3 Endovascular Inc.

Learn more about this trial

Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

We'll reach out to this number within 24 hrs