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Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial (CREATE)

Primary Purpose

Carotid Artery Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device
Sponsored by
Medtronic Endovascular
About
Eligibility
Locations
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
  • 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

Sites / Locations

  • Banner Baywood Heart Hospital
  • Scripps Memorial Hospital
  • El Camino Hospital
  • Hoag Memorial Hospital
  • Salinas Valley Memorial Healthcare System
  • Washington Hospital Center
  • St. Francis Medical Center
  • St. Vincent Hospital & Health Care Centers
  • The Heart Center of Indiana
  • Kramer & Crouse Cardiology
  • Terrebonne General Hospital
  • Southwest Medical Center
  • Union Memorial Hospital
  • Washington Adventist Hospital
  • Oakwood Hospital
  • William Beaumont Hospital
  • St. Louis University Medical Center
  • University of Buffalo Millard Fillmore Hospital
  • Duke University Medical Center
  • Wake Heart Associates
  • Cleveland Clinic Foundation
  • Riverside Methodist
  • Holy Spirit Hospital
  • Hahnemann University Hospital
  • Allegheny General Hospital
  • Pinnacle Health at Harrisburg Hospital
  • Greenville Hospital System
  • Avera Heart Hospital of South Dakota
  • Baptist Heart Institute
  • University of Virginia
  • Swedish Medical Center

Outcomes

Primary Outcome Measures

Myocardial infarction, ipsilateral cerebrovascular accident, procedure-related contralateral CVA or death within 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation

Secondary Outcome Measures

Ipsilateral CVA, procedure-related contralateral CVA or death with 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation
Target lesion revascularization
Target vessel revascularization
Primary patency at one year (<70% stenosis as measured by duplex scan)
Technical success (defined as the ability to deploy the filter, place the stent over the filter wire, and recapture the filter with the resulting residual stenosis <50%)

Full Information

First Posted
February 7, 2008
Last Updated
May 12, 2021
Sponsor
Medtronic Endovascular
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1. Study Identification

Unique Protocol Identification Number
NCT00619775
Brief Title
Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
Acronym
CREATE
Official Title
Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (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
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.

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
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
419 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device
Intervention Description
Carotid artery stenting with distal embolic protection.
Primary Outcome Measure Information:
Title
Myocardial infarction, ipsilateral cerebrovascular accident, procedure-related contralateral CVA or death within 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation
Time Frame
30 days and one year
Secondary Outcome Measure Information:
Title
Ipsilateral CVA, procedure-related contralateral CVA or death with 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation
Time Frame
30 days and one year
Title
Target lesion revascularization
Time Frame
one year
Title
Target vessel revascularization
Time Frame
one year
Title
Primary patency at one year (<70% stenosis as measured by duplex scan)
Time Frame
one year
Title
Technical success (defined as the ability to deploy the filter, place the stent over the filter wire, and recapture the filter with the resulting residual stenosis <50%)
Time Frame
at implant

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Safian, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner Baywood Heart Hospital
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85205
Country
United States
Facility Name
Scripps Memorial Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Hoag Memorial Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Salinas Valley Memorial Healthcare System
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
St. Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
St. Vincent Hospital & Health Care Centers
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
The Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Kramer & Crouse Cardiology
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Terrebonne General Hospital
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Southwest Medical Center
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Oakwood Hospital
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
St. Louis University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Buffalo Millard Fillmore Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
Duke University Medical Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Wake Heart Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Riverside Methodist
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Holy Spirit Hospital
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Hahnemann University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Pinnacle Health at Harrisburg Hospital
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Avera Heart Hospital of South Dakota
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Baptist Heart Institute
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16781363
Citation
Safian RD, Bresnahan JF, Jaff MR, Foster M, Bacharach JM, Maini B, Turco M, Myla S, Eles G, Ansel GM; CREATE Pivotal Trial Investigators. Protected carotid stenting in high-risk patients with severe carotid artery stenosis. J Am Coll Cardiol. 2006 Jun 20;47(12):2384-9. doi: 10.1016/j.jacc.2005.12.076.
Results Reference
result
PubMed Identifier
15343559
Citation
Safian RD, Bacharach JM, Ansel GM, Criado FJ. Carotid stenting with a new system for distal embolic protection and stenting in high-risk patients: the carotid revascularization with ev3 arterial technology evolution (CREATE) feasibility trial. Catheter Cardiovasc Interv. 2004 Sep;63(1):1-6. doi: 10.1002/ccd.20155.
Results Reference
result

Learn more about this trial

Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial

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