Clinical trial NCT00741091: A Carotid Stenting Boston Scientific Surveillance Program
Official title: A Carotid Stenting Boston Scientific Surveillance Program Carotid WALLSTENT Monorail Endoprosthesis FilterWire EZ™ Embolic Protection System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carotid Artery Disease
Keywords: Cerebrovascular Disease
Carotid Stent
Stent
Carotid Endarterectomy (CEA)
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 1097
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)
timeFrame: 30 days
Secondary outcomes:
measure: Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)
timeFrame: 30 days
measure: Target Lesion Revascularization
timeFrame: 30 days
measure: System Technical Success
timeFrame: 30 days
measure: Device Malfunction
timeFrame: 30 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Baptist Medical Center Princeton
state: Alabama
city: Fairhope
country: United States
facility: Cardiology Associates of Mobile
state: Alabama
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center, Barrow Neurological Institute
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona Vascular Institute
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: Bakersfield
country: United States
facility: Central Cardiology Medical Clinic
state: California
city: Los Angeles
country: United States
facility: Los Angeles Cardiology Associates
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Newport Beach
country: United States
facility: Hoag Hospital
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Salinas
country: United States
facility: Salinas Valley Memorial Healthcare System
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Center
state: California
city: Walnut Creek
country: United States
facility: San Ramon Regional Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Waterbury
country: United States
facility: Waterbury Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Cardiovascular Research
state: Delaware
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Boca Raton
country: United States
facility: Delray Medical Center
state: Florida
city: Boynton Beach
country: United States
facility: Bethesda Memorial Hospital
state: Florida
city: Bradenton
country: United States
facility: Bradenton Cardiology
state: Florida
city: Fort Lauderdale
country: United States
facility: Jim Moran Heart and Vascular Research Institute
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hollywood
country: United States
facility: Aventura Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Ocala
country: United States
facility: MediQuest Research Group Inc at Munroe Regional Medical Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute, Inc.
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: St. Joseph's Research Institute
state: Georgia
city: Austell
country: United States
facility: Vascular Surgical Associates PC
state: Georgia
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Peoria
country: United States
facility: Peoria Radiology Research & Education Foundation
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital, Prairie Education and Research Cooperative
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University - Memorial Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Indianapolis
country: United States
facility: The Indiana Heart Hospital
state: Indiana
city: Louisville
country: United States
facility: Norton Hospital
state: Kentucky
city: Monroe
country: United States
facility: Physicians and Surgeons Surgical Hospital
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Opelousas
country: United States
facility: Opelousas General Health Center
state: Louisiana
city: Clinton
country: United States
facility: Southern Maryland Hospital Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Flint
country: United States
facility: Michigan Vascular Research Center
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Saginaw
country: United States
facility: Covenant Medical Center
state: Michigan
city: St. Joseph
country: United States
facility: Great Lakes Heart and Vascular
state: Michigan
city: Robbinsdale
country: United States
facility: North Memorial Medical Center
state: Minnesota
city: Joplin
country: United States
facility: Freeman Heart & Vascular Institute
state: Missouri
city: Joplin
country: United States
facility: St. John's Regional Medical Center
state: Missouri
city: Kansas City
country: United States
facility: St. Joseph Medical Center
state: Missouri
city: Omaha
country: United States
facility: The Cardiac Center of Creighton University
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Cherry Hill
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: UMDNJ-Robert Wood Johnson Medical School
state: New Jersey
city: Newark
country: United States
facility: St. Michael's Medical Center
state: New Jersey
city: Short Hills
country: United States
facility: Overlook Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute, PA
state: New Mexico
city: Albany
country: United States
facility: Albany Medical Center Hospital
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Buffalo
country: United States
facility: Kaleida Health
state: New York
city: Buffalo
country: United States
facility: Mercy Hospital of Buffalo
state: New York
city: Liverpool
country: United States
facility: St. Joseph Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Columbus
country: United States
facility: Grant Medical Center
state: Ohio
city: Portsmouth
country: United States
facility: Southern Ohio Medical Center
state: Ohio
city: Toledo
country: United States
facility: Mercy St. Vincent
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
city: Willoughby
country: United States
facility: Lake West Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Stroke Center
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: Central PA Cardiovascular Research Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital of the University of Pennsylvania Health System
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health at Harrisburg Hospital
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Cardiologists, Ltd.
state: Pennsylvania
city: Yardley
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Heart Center
state: South Carolina
city: Greenville
country: United States
facility: University Medical Center - Greenville Memorial Hospital
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center - Sanford Clinical Research
state: South Dakota
city: Chattanooga
country: United States
facility: Erlanger Hospital
state: Tennessee
city: Chattanooga
country: United States
facility: Memorial Hospital
state: Tennessee
city: Kingsport
country: United States
facility: Cardiovascular Associates PC
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: Baptist Hospital West
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital-Memphis
state: Tennessee
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons (CTVS)
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Dallas
country: United States
facility: Presbyterian Hospital of Dallas
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: San Antonio
country: United States
facility: Peripheral Vascular Associates
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Tacoma
country: United States
facility: St. Joseph Hospital
state: Washington
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Boston Scientific Corporation
name: Pamela Grady, Ph.D
role: STUDY_DIRECTOR
References:
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.
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.