Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
Sponsor
Medtronic Endovascular (Industry)
Overall Status
Completed
CT.gov ID
NCT00619775
Collaborator
(none)
419
31
18
13.5
0.8
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
419 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
Study Start Date
:
Apr 1, 2004
Actual Study Completion Date
:
Oct 1, 2005
Outcome Measures
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 [30 days and one year]
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 [30 days and one year]
- Target lesion revascularization [one year]
- Target vessel revascularization [one year]
- Primary patency at one year (<70% stenosis as measured by duplex scan) [one year]
- 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%) [at implant]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Banner Baywood Heart Hospital | Mesa | Arizona | United States | 85205 |
| 2 | Scripps Memorial Hospital | La Jolla | California | United States | 92037 |
| 3 | El Camino Hospital | Mountain View | California | United States | 94040 |
| 4 | Hoag Memorial Hospital | Newport Beach | California | United States | 92663 |
| 5 | Salinas Valley Memorial Healthcare System | Salinas | California | United States | 93901 |
| 6 | Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 7 | St. Francis Medical Center | Peoria | Illinois | United States | 61637 |
| 8 | St. Vincent Hospital & Health Care Centers | Indianapolis | Indiana | United States | 46260 |
| 9 | The Heart Center of Indiana | Indianapolis | Indiana | United States | 46290 |
| 10 | Kramer & Crouse Cardiology | Shawnee Mission | Kansas | United States | 66204 |
| 11 | Terrebonne General Hospital | Houma | Louisiana | United States | 70360 |
| 12 | Southwest Medical Center | Lafayette | Louisiana | United States | 70506 |
| 13 | Union Memorial Hospital | Baltimore | Maryland | United States | 21218 |
| 14 | Washington Adventist Hospital | Takoma Park | Maryland | United States | 20912 |
| 15 | Oakwood Hospital | Dearborn | Michigan | United States | 48124 |
| 16 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
| 17 | St. Louis University Medical Center | Saint Louis | Missouri | United States | 63110 |
| 18 | University of Buffalo Millard Fillmore Hospital | Buffalo | New York | United States | 14209 |
| 19 | Duke University Medical Center | Raleigh | North Carolina | United States | 27609 |
| 20 | Wake Heart Associates | Raleigh | North Carolina | United States | 27610 |
| 21 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44111 |
| 22 | Riverside Methodist | Columbus | Ohio | United States | 43214 |
| 23 | Holy Spirit Hospital | Harrisburg | Pennsylvania | United States | 17110 |
| 24 | Hahnemann University Hospital | Philadelphia | Pennsylvania | United States | 19102 |
| 25 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
| 26 | Pinnacle Health at Harrisburg Hospital | Wormleysburg | Pennsylvania | United States | 17043 |
| 27 | Greenville Hospital System | Greenville | South Carolina | United States | 29605 |
| 28 | Avera Heart Hospital of South Dakota | Sioux Falls | South Dakota | United States | 57108 |
| 29 | Baptist Heart Institute | Knoxville | Tennessee | United States | 37920 |
| 30 | University of Virginia | Charlottesville | Virginia | United States | 22908 |
| 31 | Swedish Medical Center | Seattle | Washington | United States | 98122 |
Sponsors and Collaborators
- Medtronic Endovascular
Investigators
- Principal Investigator: Robert Safian, MD, William Beaumont Hospitals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00619775
Other Study ID Numbers:
- P-1007
First Posted:
Feb 21, 2008
Last Update Posted:
May 14, 2021
Last Verified:
Dec 1, 2008
Keywords provided by Medtronic Endovascular
Additional relevant MeSH terms: