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A Carotid Stenting Boston Scientific Surveillance Program (CABANA)

Primary Purpose

Carotid Artery Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Carotid WALLSTENT Monorail Endoprosthesis
FilterWire EZ™ System™
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Disease focused on measuring Cerebrovascular Disease, Carotid Stent, Stent, Carotid Endarterectomy (CEA)

Eligibility Criteria

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

Inclusion Criteria:

  • Subject at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who requires carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.
  • Subject with neurological symptoms and greater than or equal to 50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram OR
  • Subjects without neurological symptoms and greater than or equal to 80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram.
  • Subject has a reference vessel diameter greater than or equal to 4.0 mm and less than or equal to 9.0 mm at the target lesion and a vessel diameter distal to the target lesion of greater than or equal to 3.5 mm and less than or equal to 5.5 mm as optimal "landing zone" for placement of the FilterWire EZ System.
  • Subject is willing and able to comply with all follow-up requirements.
  • Subject has provided a signed informed consent prior to participation in the Registry.

Exclusion Criteria:

  • Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated
  • Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system
  • Patients with uncorrected bleeding disorders
  • Lesions in the ostium of the common carotid artery.

Sites / Locations

  • Baptist Medical Center Princeton
  • Cardiology Associates of Mobile
  • St. Joseph's Hospital and Medical Center, Barrow Neurological Institute
  • Southern Arizona Vascular Institute
  • University of Arkansas
  • Central Cardiology Medical Clinic
  • Los Angeles Cardiology Associates
  • Ronald Reagan UCLA Medical Center
  • Hoag Hospital
  • VA Palo Alto Health Care System
  • Salinas Valley Memorial Healthcare System
  • University of California, San Francisco
  • St. Joseph's Medical Center
  • San Ramon Regional Medical Center
  • University of Colorado Hospital
  • University of Connecticut Health Center
  • Waterbury Hospital
  • Christiana Care Cardiovascular Research
  • JFK Medical Center
  • Delray Medical Center
  • Bethesda Memorial Hospital
  • Bradenton Cardiology
  • Jim Moran Heart and Vascular Research Institute
  • University of Florida
  • Aventura Hospital
  • University of Miami Hospital
  • Baptist Hospital of Miami
  • MediQuest Research Group Inc at Munroe Regional Medical Center
  • Tallahassee Research Institute, Inc.
  • Emory University Hospital
  • Piedmont Hospital
  • St. Joseph's Research Institute
  • Vascular Surgical Associates PC
  • Advocate Christ Medical Center
  • Peoria Radiology Research & Education Foundation
  • St. John's Hospital, Prairie Education and Research Cooperative
  • Southern Illinois University - Memorial Medical Center
  • Indiana University School of Medicine
  • The Indiana Heart Hospital
  • Norton Hospital
  • Physicians and Surgeons Surgical Hospital
  • Ochsner Clinic Foundation
  • Opelousas General Health Center
  • Southern Maryland Hospital Center
  • Beth Israel Deaconess Medical Center
  • University of Michigan
  • Michigan Vascular Research Center
  • Northern Michigan Hospital
  • Covenant Medical Center
  • Great Lakes Heart and Vascular
  • North Memorial Medical Center
  • Freeman Heart & Vascular Institute
  • St. John's Regional Medical Center
  • St. Joseph Medical Center
  • The Cardiac Center of Creighton University
  • Dartmouth Hitchcock Medical Center
  • Cooper University Hospital
  • Our Lady of Lourdes Medical Center
  • UMDNJ-Robert Wood Johnson Medical School
  • St. Michael's Medical Center
  • Overlook Hospital
  • New Mexico Heart Institute, PA
  • Albany Medical Center Hospital
  • Maimonides Medical Center
  • Kaleida Health
  • Mercy Hospital of Buffalo
  • St. Joseph Hospital
  • Mount Sinai Medical Center
  • Stony Brook University Medical Center
  • Wake Medical Center
  • Forsyth Medical Center
  • Bethesda North Hospital
  • Cleveland Clinic Foundation
  • Riverside Methodist Hospital
  • Grant Medical Center
  • Southern Ohio Medical Center
  • Mercy St. Vincent
  • University of Toledo Medical Center
  • Lake West Hospital
  • Oregon Stroke Center
  • Lehigh Valley Hospital
  • Central PA Cardiovascular Research Institute
  • Pennsylvania Hospital of the University of Pennsylvania Health System
  • Pinnacle Health at Harrisburg Hospital
  • Berks Cardiologists, Ltd.
  • St. Mary Medical Center
  • York Hospital
  • Rhode Island Hospital
  • Medical University of South Carolina
  • South Carolina Heart Center
  • University Medical Center - Greenville Memorial Hospital
  • Sanford USD Medical Center - Sanford Clinical Research
  • Erlanger Hospital
  • Memorial Hospital
  • Cardiovascular Associates PC
  • University of Tennessee Medical Center
  • Baptist Hospital West
  • Baptist Memorial Hospital-Memphis
  • Cardiothoracic and Vascular Surgeons (CTVS)
  • Medical City Dallas Hospital
  • Presbyterian Hospital of Dallas
  • University of Texas Medical Branch
  • St. Luke's Episcopal Hospital
  • The Methodist Hospital
  • The Heart Hospital Baylor Plano
  • Peripheral Vascular Associates
  • University of Texas Health Science Center San Antonio
  • Inova Fairfax Hospital
  • Sentara Norfolk General Hospital
  • Swedish Medical Center
  • St. Joseph Hospital
  • Aurora St. Luke's Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Registry

Arm Description

Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.

Outcomes

Primary Outcome Measures

Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)
Number of participants who experienced a major adverse event (MAE) 0-30 days post-procedure. MAE was defined as add death, stroke, and myocardial infarction(MI).

Secondary Outcome Measures

Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)
Adverse events, serious and non-serious, were reported by all study centers. Device related adverse events were defined as any adverse event related the study device as determined by the (Principal Investigator)PI. Procedure related adverse events were defined as any adverse event related the study procedure as determine by the PI. Unrelated adverse events were determined by the PI to not be related to the study device or study procedure.
Target Lesion Revascularization
Number of participant with any surgical or percutaneous attempt to revascularize the target lesion after the initial treatment. The target lesion was defined as the stented segment including 0.5 cm at the proximal and distal margins of the stented segment.
System Technical Success
System technical success included successful delivery and deployment of the FilterWire EZ System beyond the target lesion site, delivery and deployment of the Carotid WALLSTENT Endoprosthesis at the intended location, and successful retrieval of the delivery catheter and FilterWire EZ System after stent placement. System technical success rates was calculated based on the number of participants who had both the FilterWire EZ System and Carotid WALLSTENT Endoprosthesis placement attempted.
Device Malfunction
Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.

Full Information

First Posted
August 25, 2008
Last Updated
August 22, 2011
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00741091
Brief Title
A Carotid Stenting Boston Scientific Surveillance Program
Acronym
CABANA
Official Title
A Carotid Stenting Boston Scientific Surveillance Program Carotid WALLSTENT Monorail Endoprosthesis FilterWire EZ™ Embolic Protection System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
CABANA is a multicenter U.S. surveillance registry that will be conducted to compile early clinical outcomes data for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice and to assess the adequacy of the Boston Scientific Corporation (BSC) Carotid Stenting Training Program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Disease
Keywords
Cerebrovascular Disease, Carotid Stent, Stent, Carotid Endarterectomy (CEA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1097 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Registry
Arm Type
Experimental
Arm Description
Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
Intervention Type
Device
Intervention Name(s)
Carotid WALLSTENT Monorail Endoprosthesis
Intervention Description
A carotid artery stent for use in subjects at high risk for adverse events from Carotid endarterectomy (CEA) due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.
Intervention Type
Device
Intervention Name(s)
FilterWire EZ™ System™
Intervention Description
Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.
Primary Outcome Measure Information:
Title
Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)
Description
Number of participants who experienced a major adverse event (MAE) 0-30 days post-procedure. MAE was defined as add death, stroke, and myocardial infarction(MI).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)
Description
Adverse events, serious and non-serious, were reported by all study centers. Device related adverse events were defined as any adverse event related the study device as determined by the (Principal Investigator)PI. Procedure related adverse events were defined as any adverse event related the study procedure as determine by the PI. Unrelated adverse events were determined by the PI to not be related to the study device or study procedure.
Time Frame
30 days
Title
Target Lesion Revascularization
Description
Number of participant with any surgical or percutaneous attempt to revascularize the target lesion after the initial treatment. The target lesion was defined as the stented segment including 0.5 cm at the proximal and distal margins of the stented segment.
Time Frame
30 days
Title
System Technical Success
Description
System technical success included successful delivery and deployment of the FilterWire EZ System beyond the target lesion site, delivery and deployment of the Carotid WALLSTENT Endoprosthesis at the intended location, and successful retrieval of the delivery catheter and FilterWire EZ System after stent placement. System technical success rates was calculated based on the number of participants who had both the FilterWire EZ System and Carotid WALLSTENT Endoprosthesis placement attempted.
Time Frame
30 days
Title
Device Malfunction
Description
Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who requires carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease. Subject with neurological symptoms and greater than or equal to 50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram OR Subjects without neurological symptoms and greater than or equal to 80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram. Subject has a reference vessel diameter greater than or equal to 4.0 mm and less than or equal to 9.0 mm at the target lesion and a vessel diameter distal to the target lesion of greater than or equal to 3.5 mm and less than or equal to 5.5 mm as optimal "landing zone" for placement of the FilterWire EZ System. Subject is willing and able to comply with all follow-up requirements. Subject has provided a signed informed consent prior to participation in the Registry. Exclusion Criteria: Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system Patients with uncorrected bleeding disorders Lesions in the ostium of the common carotid artery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Grady, Ph.D
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Baptist Medical Center Princeton
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Cardiology Associates of Mobile
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center, Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Southern Arizona Vascular Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
University of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Central Cardiology Medical Clinic
City
Bakersfield
State/Province
California
ZIP/Postal Code
93308
Country
United States
Facility Name
Los Angeles Cardiology Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Hoag Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Salinas Valley Memorial Healthcare System
City
Salinas
State/Province
California
ZIP/Postal Code
93907
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
St. Joseph's Medical Center
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
San Ramon Regional Medical Center
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Waterbury Hospital
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Christiana Care Cardiovascular Research
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
JFK Medical Center
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Delray Medical Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Bethesda Memorial Hospital
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Bradenton Cardiology
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Jim Moran Heart and Vascular Research Institute
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Aventura Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
MediQuest Research Group Inc at Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Tallahassee Research Institute, Inc.
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
St. Joseph's Research Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Vascular Surgical Associates PC
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Peoria Radiology Research & Education Foundation
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
St. John's Hospital, Prairie Education and Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Southern Illinois University - Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The Indiana Heart Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Norton Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Physicians and Surgeons Surgical Hospital
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Opelousas General Health Center
City
Opelousas
State/Province
Louisiana
ZIP/Postal Code
70570
Country
United States
Facility Name
Southern Maryland Hospital Center
City
Clinton
State/Province
Maryland
ZIP/Postal Code
20735
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Michigan Vascular Research Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
Country
United States
Facility Name
Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Covenant Medical Center
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Great Lakes Heart and Vascular
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
North Memorial Medical Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Freeman Heart & Vascular Institute
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
St. John's Regional Medical Center
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
St. Joseph Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
The Cardiac Center of Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Our Lady of Lourdes Medical Center
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
UMDNJ-Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
St. Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Overlook Hospital
City
Short Hills
State/Province
New Jersey
ZIP/Postal Code
07078
Country
United States
Facility Name
New Mexico Heart Institute, PA
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
82102
Country
United States
Facility Name
Albany Medical Center Hospital
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Kaleida Health
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
Mercy Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
St. Joseph Hospital
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Wake Medical Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Bethesda North Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Grant Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Southern Ohio Medical Center
City
Portsmouth
State/Province
Ohio
ZIP/Postal Code
45662
Country
United States
Facility Name
Mercy St. Vincent
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Lake West Hospital
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
Oregon Stroke Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Central PA Cardiovascular Research Institute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Pennsylvania Hospital of the University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Pinnacle Health at Harrisburg Hospital
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Berks Cardiologists, Ltd.
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
St. Mary Medical Center
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
South Carolina Heart Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
University Medical Center - Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Sanford USD Medical Center - Sanford Clinical Research
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Erlanger Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Memorial Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Cardiovascular Associates PC
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Baptist Hospital West
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
Baptist Memorial Hospital-Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Cardiothoracic and Vascular Surgeons (CTVS)
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Presbyterian Hospital of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Peripheral Vascular Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
University of Texas Health Science Center San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
St. Joseph Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24948033
Citation
Hopkins LN, White CJ, Foster MT, Powell RJ, Zemel G, Diaz-Cartelle J. Carotid artery stenting and patient outcomes: the CABANA surveillance study. Catheter Cardiovasc Interv. 2014 Nov 15;84(6):997-1004. doi: 10.1002/ccd.25578. Epub 2014 Jul 18.
Results Reference
derived
PubMed Identifier
21805584
Citation
White CJ, Avula SB, Mintz RT, Iskander A, Chervu A, Feldman RL, Schermerhorn ML, Woo HH, Hopkins LN. Carotid artery revascularization with distal protection in high-surgical-risk patients in routine clinical practice: rationale and design of the CABANA safety surveillance program. Catheter Cardiovasc Interv. 2012 Jan 1;79(1):167-73. doi: 10.1002/ccd.23257. Epub 2011 Oct 5.
Results Reference
derived

Learn more about this trial

A Carotid Stenting Boston Scientific Surveillance Program

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