Carotid Artery DiseasePhase 4CABANANCT00741091

A Carotid Stenting Boston Scientific Surveillance Program

A Phase 4 study testing Carotid WALLSTENT Monorail Endoprosthesis and FilterWire EZ™ System™ in people with Carotid Artery Disease, run by Boston Scientific Corporation at 112 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carotid Artery Disease
What is being tested?: Carotid WALLSTENT Monorail Endoprosthesis and FilterWire EZ™ System™
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,097 participants
Where: 112 sitesUnited States
Study dates: Dec 2008to Oct 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

112 sites in 1 country.

City, postcode or hospital

112 sites in 1 country

United States112 sites

Albany Medical Center Hospital
Albany, New York, 12208
New Mexico Heart Institute, PA
Albuquerque, New Mexico, 82102
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
University of Michigan
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30308
Piedmont Hospital
Atlanta, Georgia, 30309
St. Joseph's Research Institute
Atlanta, Georgia, 30342
JFK Medical Center
Atlantis, Florida, 33462
University of Colorado Hospital
Aurora, Colorado, 80045
Vascular Surgical Associates PC
Austell, Georgia, 30106
Cardiothoracic and Vascular Surgeons (CTVS)
Austin, Texas, 78756
Central Cardiology Medical Clinic
Bakersfield, California, 93308
Baptist Medical Center Princeton
Birmingham, Alabama, 35211
Delray Medical Center
Boca Raton, Florida, 33487
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Bethesda Memorial Hospital
Boynton Beach, Florida, 33435
Bradenton Cardiology
Bradenton, Florida, 34205
Maimonides Medical Center
Brooklyn, New York, 11219
Kaleida Health
Buffalo, New York, 14209
Mercy Hospital of Buffalo
Buffalo, New York, 14221
Cooper University Hospital
Camden, New Jersey, 08103
Medical University of South Carolina
Charleston, South Carolina, 29425
Erlanger Hospital
Chattanooga, Tennessee, 37403
Memorial Hospital
Chattanooga, Tennessee, 37404
Our Lady of Lourdes Medical Center
Cherry Hill, New Jersey, 08034
Bethesda North Hospital
Cincinnati, Ohio, 45242
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Southern Maryland Hospital Center
Clinton, Maryland, 20735
South Carolina Heart Center
Columbia, South Carolina, 29204
Riverside Methodist Hospital
Columbus, Ohio, 43214
Grant Medical Center
Columbus, Ohio, 43215
Medical City Dallas Hospital
Dallas, Texas, 75230
Presbyterian Hospital of Dallas
Dallas, Texas, 75231
Cardiology Associates of Mobile
Fairhope, Alabama, 36532
Inova Fairfax Hospital
Falls Church, Virginia, 22042
University of Connecticut Health Center
Farmington, Connecticut, 06030
Michigan Vascular Research Center
Flint, Michigan, 48507
Jim Moran Heart and Vascular Research Institute
Fort Lauderdale, Florida, 33308
University of Florida
Gainesville, Florida, 32611
University of Texas Medical Branch
Galveston, Texas, 77555
University Medical Center - Greenville Memorial Hospital
Greenville, South Carolina, 29605
Central PA Cardiovascular Research Institute
Harrisburg, Pennsylvania, 17110
Aventura Hospital
Hollywood, Florida, 33021
St. Luke's Episcopal Hospital
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
Indiana University School of Medicine
Indianapolis, Indiana, 46202
The Indiana Heart Hospital
Indianapolis, Indiana, 46250
Freeman Heart & Vascular Institute
Joplin, Missouri, 64804
St. John's Regional Medical Center
Joplin, Missouri, 64804
St. Joseph Medical Center
Kansas City, Missouri, 64114
Cardiovascular Associates PC
Kingsport, Tennessee, 37660
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Baptist Hospital West
Knoxville, Tennessee, 37934
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Arkansas
Little Rock, Arkansas, 72205
St. Joseph Hospital
Liverpool, New York, 13088
Los Angeles Cardiology Associates
Los Angeles, California, 90017
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Norton Hospital
Louisville, Kentucky, 40202
Baptist Memorial Hospital-Memphis
Memphis, Tennessee, 38120
University of Miami Hospital
Miami, Florida, 33136
Baptist Hospital of Miami
Miami, Florida, 33176
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53233
Physicians and Surgeons Surgical Hospital
Monroe, Louisiana, 71201
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Mount Sinai Medical Center
New York, New York, 10029
Christiana Care Cardiovascular Research
Newark, Delaware, 19718
St. Michael's Medical Center
Newark, New Jersey, 07102
Hoag Hospital
Newport Beach, California, 92663
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
MediQuest Research Group Inc at Munroe Regional Medical Center
Ocala, Florida, 34471
The Cardiac Center of Creighton University
Omaha, Nebraska, 68131
Opelousas General Health Center
Opelousas, Louisiana, 70570
VA Palo Alto Health Care System
Palo Alto, California, 94304
Peoria Radiology Research & Education Foundation
Peoria, Illinois, 61637
Northern Michigan Hospital
Petoskey, Michigan, 49770
Pennsylvania Hospital of the University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19106
St. Joseph's Hospital and Medical Center, Barrow Neurological Institute
Phoenix, Arizona, 85013
The Heart Hospital Baylor Plano
Plano, Texas, 75024
Oregon Stroke Center
Portland, Oregon, 97239
Southern Ohio Medical Center
Portsmouth, Ohio, 45662
Rhode Island Hospital
Providence, Rhode Island, 02905
Wake Medical Center
Raleigh, North Carolina, 27610
North Memorial Medical Center
Robbinsdale, Minnesota, 55422
Covenant Medical Center
Saginaw, Michigan, 48602
Great Lakes Heart and Vascular
Saint Joseph, Michigan, 49085
Salinas Valley Memorial Healthcare System
Salinas, California, 93907
Peripheral Vascular Associates
San Antonio, Texas, 78205
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
University of California, San Francisco
San Francisco, California, 94143
Swedish Medical Center
Seattle, Washington, 98122
Overlook Hospital
Short Hills, New Jersey, 07078
Sanford USD Medical Center - Sanford Clinical Research
Sioux Falls, South Dakota, 57105
St. John's Hospital, Prairie Education and Research Cooperative
Springfield, Illinois, 62701
Southern Illinois University - Memorial Medical Center
Springfield, Illinois, 62702
St. Joseph's Medical Center
Stockton, California, 95204
Stony Brook University Medical Center
Stony Brook, New York, 11794
St. Joseph Hospital
Tacoma, Washington, 98405
Tallahassee Research Institute, Inc.
Tallahassee, Florida, 32308
Mercy St. Vincent
Toledo, Ohio, 43608
University of Toledo Medical Center
Toledo, Ohio, 43614
Southern Arizona Vascular Institute
Tucson, Arizona, 85741
San Ramon Regional Medical Center
Walnut Creek, California, 94598
Waterbury Hospital
Waterbury, Connecticut, 06708
Lake West Hospital
Willoughby, Ohio, 44094
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Pinnacle Health at Harrisburg Hospital
Wormleysburg, Pennsylvania, 17043
Berks Cardiologists, Ltd.
Wyomissing, Pennsylvania, 19610
St. Mary Medical Center
Yardley, Pennsylvania, 19067
York Hospital
York, Pennsylvania, 17403

Other trials in United States

About this study

Official title: A Carotid Stenting Boston Scientific Surveillance Program Carotid WALLSTENT Monorail Endoprosthesis FilterWire EZ™ Embolic Protection System

Conditions: Carotid Artery Disease
Being tested: Carotid WALLSTENT Monorail Endoprosthesis, FilterWire EZ™ System™
Keywords: Cerebrovascular Disease, Carotid Stent, Stent, Carotid Endarterectomy (CEA)
Medical subject headings: Carotid Artery Diseases, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Carotid WALLSTENT Monorail EndoprosthesisDevice
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.
FilterWire EZ™ System™Device
Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.

Study groups in NCT00741091
Study group	Role	What they receive
Registry	Experimental	Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice. Receives: Device: Carotid WALLSTENT Monorail Endoprosthesis; Device: FilterWire EZ™ System™

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 30 days

Secondary outcomes (4)

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.
Measured: 30 days
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.
Measured: 30 days
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.
Measured: 30 days
Device Malfunction
Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Oct 2010

First posted26 Aug 2008 (estimated)
Study startDec 2008
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Carotid Artery DiseaseStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,097 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00741091
Sponsor's protocol ID: S2029
Acronym: CABANA
Status last verified: Aug 2011
First submitted: 25 Aug 2008
Last updated: 24 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 24948033
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.
PubMed 21805584

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Carotid Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Carotid Stenting Boston Scientific Surveillance Program Carotid WALLSTENT Monorail Endoprosthesis FilterWire EZ™ Embolic Protection System
ClinicalTrials.gov ID: NCT00741091
Acronym / sponsor ID: CABANA / S2029
Conditions: Carotid Artery Disease
Keywords: Cerebrovascular Disease, Carotid Stent, Stent, Carotid Endarterectomy (CEA)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,097 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 26 Aug 2008 (estimated)
Results: Posted 19 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Registry	Experimental	Device: Carotid WALLSTENT Monorail Endoprosthesis, Device: FilterWire EZ™ System™Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Carotid WALLSTENT Monorail EndoprosthesisA 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.	Device	Registry
FilterWire EZ™ System™Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.	Device	Registry

Primary outcome

Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)
Time frame: 30 days
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).

4 secondary outcomes

Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)
Time frame: 30 days
Target Lesion Revascularization
Time frame: 30 days
System Technical Success
Time frame: 30 days
Device Malfunction
Time frame: 30 days

Results and safety

Results posted to the registry on 19 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Carotid WALLSTENT Endoprothesis and FilterWire EZ System	1,097	1,040

Primary outcome: Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)

Time frame: 30 days. Number. Unit: Participants

Measure	Carotid WALLSTENT Endoprothesis and FilterWire EZ System n = 1025
Value	47

Population analysed: All 1097 enrolled participants were considered for analysis. A total of 1025 subjects were evaluable for MAEs. Seventy two participants were not evaluable for MAEs; 32 participants were not evaluable because the follow-up occurred less than 23 days from enrollment and 40 participants did not complete the expected follow-up.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Carotid WALLSTENT Endoprothesis and FilterWire EZ System	230 of 1,097 (21%)	332 of 1,097 (30.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24948033Hopkins 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.
Derived from this study: PubMed 21805584White 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.

Related trials for Carotid Artery Disease

RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pamela Grady, Ph.D study director

Boston Scientific Corporation

112 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI) (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00741091, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2011.