Carotid StenosisPhase 4SONOMANCT00478673

Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMA

A Phase 4 study testing NexStent Carotid Stent System (Monorail Delivery System) and FilterWire EZ™ Embolic Protection System in people with Carotid Stenosis, run by Boston Scientific Corporation at 62 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary objective of the SONOMA Registry is to confirm the safety of the NexStent® Carotid Stent System and FilterWire EZ™ Embolic Protection System in routine clinical practice and to identify rare or unanticipated device-related events that might occur. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carotid Stenosis
What is being tested?: NexStent Carotid Stent System (Monorail Delivery System) and FilterWire EZ™ Embolic Protection System
Type of treatment: Medical device
How many people: 298 participants
Where: 62 sitesUnited States
Study dates: May 2007to Jul 2009
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

Candidates must be indicated for carotid stent placement as per NexStent Carotid Stent labeling located in the Directions for Use (DFU).

Who cannot join

Subjects with contraindications as outlined in the DFU should be excluded from this registry.

Trial locations and contacts

62 sites in 1 country.

City, postcode or hospital

62 sites in 1 country

United States62 sites

Albany Medical Center Hospital
Albany, New York, 12208
New Mexico Heart Institute, PA
Albuquerque, New Mexico, 87102
Piedmont Hospital
Atlanta, Georgia, 30309
JFK Medical Center
Atlantis, Florida, 33462
Central Cardiology Medical Clinic
Bakersfield, California, 93308
Heritage Valley Health System
Beaver, Pennsylvania, 15009
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Caritas St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135
Kaleida Health
Buffalo, New York, 14209
Our Lady of Lourdes Medical Center
Camden, New Jersey, 08103
Erlanger Medical Center
Chattanooga, Tennessee, 37403
Cleveland Clinic and Foundation
Cleveland, Ohio, 44195
South Carolina Heart Center
Columbia, South Carolina, 29204
Ohio State University Medical
Columbus, Ohio, 43210
Riverside Methodist Hospital
Columbus, Ohio, 43214
Dallas Fort Worth Vascular
Dallas, Texas, 75208
Presbyterian Hospital of Dallas
Dallas, Texas, 75231
Geisinger Clinic
Danville, Pennsylvania, 17822
University of Connecticut Health Center
Farmington, Connecticut, 06030-1705
Northern Indiana Research Alliance
Fort Wayne, Indiana, 46804
Heart Center of North Texas
Fort Worth, Texas, 76104
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Center PA Cardiovascular Research Institute
Harrisburg, Pennsylvania, 17110
Terrebonne General Medical Center
Houma, Louisiana, 70360
St. Luke's Episcopal Hospital
Houston, Texas, 77030
Huntsville Hospital Heart Center
Huntsville, Alabama, 35801
The Indiana Heart Hospital
Indianapolis, Indiana, 46256
St. Luke's Hospital
Kansas City, Missouri, 64111
Cardiovascular Associates, PC Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Los Angeles Cardiology Associates
Los Angeles, California, 90017
Northwest Medical Center
Margate, Florida, 33063
Baptist Cardiac and Vascular Institute, Baptist Hospital of Miami
Miami, Florida, 33176
St. Joseph Regional Medical Center
Milwaukee, Wisconsin, 53210
Morristown Memorial
Morristown, New Jersey, 07960
ACS Research Group, Inc.
Mountain View, California, 94040
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Lenox Hill Hospital
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
Hoag Memorial Hospital / Presbyterian
Newport Beach, California, 92663
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Oklahoma Heart
Oklahoma City, Oklahoma, 73120
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19107
St. Luke's Medical Center
Phoenix, Arizona, 85006
William Beaumont Hospital
Royal Oak, Michigan, 48073
Great Lakes Heart & Vascular Institute
Saint Joseph, Michigan, 49085
Salinas Valley Memorial Healthcare System
Salinas, California, 93901
Central Cardiovaascular Research Foundation
San Antonio, Texas, 78201
Neurological Institute of Savannah
Savannah, Georgia, 31405
Washington Cardiovscular Research and Education Foundation
Seattle, Washington, 98121
Willis Knighton Medical Center
Shreveport, Louisiana, 71103
Providence Hospital
Southfield, Michigan, 48075
Prairie Education & Research Cooperative
Springfield, Illinois, 62701
Washington University in St. Louis
St Louis, Missouri, 63110
St. Anthony's Medical Center
St Louis, Missouri, 63128
Washington Adventist Hospital
Takoma Park, Maryland, 20912
Tampa General Hospital
Tampa, Florida, 33612
Buffalo Neurosurgery Group
Williamsville, New York, 14221
St. Mary Medical Center
Yardley, Pennsylvania, 19047
York Hospital
York, Pennsylvania, 17405
Michigan Heart PC
Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: The NexStent® Carotid Stent System: A Post Market Approval Evaluation Study In Conjunction With the FilterWire EZ™ Embolic Protection System

Read the detailed description

The SONOMA Registry will enroll approximately 300 subjects at a maximum at 78 study centers.

Conditions: Carotid Stenosis
Being tested: NexStent Carotid Stent System (Monorail Delivery System), FilterWire EZ™ Embolic Protection System
Keywords: NexStent, FilterWire EZ, Boston Scientific, Carotid Artery, Carotid Endarterectomy, Carotid Revascularization
Medical subject headings: Carotid Stenosis

What participants receive

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

NexStent Carotid Stent System (Monorail Delivery System)Device
Self-expanding carotid stent for treating patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
FilterWire EZ™ Embolic Protection SystemDevice
Used as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.

What is being measured

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

Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE)
30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Measured: 30 Days
Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE)
12-month major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure (see 30-Day MAE above), and ipsilateral stroke events that occur within 31-365 days post-procedure.
Measured: 12 Months

Timeline

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

May 2007Jul 2009

First posted25 May 2007 (estimated)
Study startMay 2007
Primary completionJul 2009
Study completionJul 2009

Why it stopped: Enrollment was terminated in June 2008 due to market withdrawal of the NexStent Carotid Stent System.

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 (1)Papers the sponsor has linked to this study.
Other trials for Carotid StenosisStudies 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: 298 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00478673
Sponsor's protocol ID: S2042
Other IDs: SONOMA
Acronym: SONOMA
Status last verified: Jul 2012
First submitted: 24 May 2007
Last updated: 7 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Qureshi AI, Knape C, Maroney J, Suri MF, Hopkins LN. Multicenter clinical trial of the NexStent coiled sheet stent in the treatment of extracranial carotid artery stenosis: immediate results and late clinical outcomes. J Neurosurg. 2003 Aug;99(2):264-70. doi: 10.3171/jns.2003.99.2.0264.
PubMed 12924698

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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PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
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A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
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All Carotid Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The NexStent® Carotid Stent System: A Post Market Approval Evaluation Study In Conjunction With the FilterWire EZ™ Embolic Protection System
ClinicalTrials.gov ID: NCT00478673
Acronym / sponsor ID: SONOMA / S2042
Conditions: Carotid Stenosis
Keywords: NexStent, FilterWire EZ, Boston Scientific, Carotid Artery, Carotid Endarterectomy, Carotid Revascularization
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Enrollment was terminated in June 2008 due to market withdrawal of the NexStent Carotid Stent System.
Enrolment: 298 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 25 May 2007 (estimated)
Results: Posted 7 Aug 2012

Clinical summary

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

Detailed description

The SONOMA Registry will enroll approximately 300 subjects at a maximum at 78 study centers.

Study design

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

Who may qualify

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

Key inclusion criteria (1 listed)

Candidates must be indicated for carotid stent placement as per NexStent Carotid Stent labeling located in the Directions for Use (DFU).

Key exclusion criteria (1 listed)

Subjects with contraindications as outlined in the DFU should be excluded from this registry.

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
NexStent Carotid Stent System (Monorail Delivery System)Self-expanding carotid stent for treating patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.	Device	–
FilterWire EZ™ Embolic Protection SystemUsed as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.	Device	–

Primary outcome

Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE)
Time frame: 30 Days
30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE)
Time frame: 12 Months
12-month major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure (see 30-Day MAE above), and ipsilateral stroke events that occur within 31-365 days post-procedure.

Results and safety

Results posted to the registry on 7 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NexStent Carotid Stent System	298	288

Primary outcome: Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE)

Time frame: 30 Days. Number. Unit: Participants

Measure	NexStent Carotid Stent System n = 293
30-Day Major Adverse Events (Overall)	13
Death (0-30 Days)	3 (2.4 to 7.5)
Stroke (0-30 Days)	10
MI (0-30 Days)	3

Population analysed: ITT Analysis: All enrolled subjects who experienced a 30-day MAE and/or completed a follow-up evaluation \>=23 days post-procedure were evaluable. Subjects who experienced more than one MAE within 30 days were counted in the number of subjects with each applicable event, but were only counted once in the number of subjects with overall 30-day MAE.

Primary outcome: Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE)

Time frame: 12 Months. Number. Unit: Participants

Measure	NexStent Carotid Stent System n = 235
12-Month Major Adverse Events (Overall)	16
Ipsilateral Stroke (31-365 Days)	4

Population analysed: ITT Analysis: All enrolled subjects who experienced a 12-mo MAE and/or completed a follow-up evaluation \>=335 days post-procedure were evaluable. Subjects who experienced more than one MAE within 12 months were counted in the number of subjects with each applicable event, but were only counted once in the number of subjects with overall 12-mo MAE.

Adverse events

Time frame: Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience.. Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NexStent Carotid Stent System	150 of 298 (50.3%)	72 of 298 (24.2%)	Not reported

Limitations and caveats (from the sponsor): Enrollment was terminated in June 2008 due to market withdrawal of the NexStent Carotid Stent System. The early termination of enrollment led to a smaller than expected number of analyzable subjects (298 actual vs. 1500 anticipated).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12924698Qureshi AI, Knape C, Maroney J, Suri MF, Hopkins LN. Multicenter clinical trial of the NexStent coiled sheet stent in the treatment of extracranial carotid artery stenosis: immediate results and late clinical outcomes. J Neurosurg. 2003 Aug;99(2):264-70. doi: 10.3171/jns.2003.99.2.0264.

Related trials for Carotid Stenosis

Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingObservational study
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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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.

Subbarao Myla, M.D. principal investigator

Hoag Memorial Hospital

Pamela Grady, PhD study director

Boston Scientific Corporation

62 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 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 7 Aug 2012). 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?

Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE) (time frame: 30 Days). The study lists 2 primary outcomes in all. 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 NCT00478673, which also lists 1 linked publication.

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 7 Aug 2012.