Carotid Stenosis
Conditions
Keywords
NexStent, FilterWire EZ, Boston Scientific, Carotid Artery, Carotid Endarterectomy, Carotid Revascularization
Brief 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.
Detailed description
The SONOMA Registry will enroll approximately 300 subjects at a maximum at 78 study centers.
Interventions
DEVICENexStent 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.
DEVICEFilterWire EZ™ Embolic Protection System
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.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Candidates must be indicated for carotid stent placement as per NexStent Carotid Stent labeling located in the Directions for Use (DFU).
Exclusion criteria
* Subjects with contraindications as outlined in the DFU should be excluded from this registry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE) | 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) | 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. |
Countries
United States
Participant flow
Recruitment details
Enrollment began on May 23, 2007. Enrollment was suspended on June 6, 2008, due to a voluntary recall of the NexStent Carotid Stent System. On June 17, 2008, enrollment was terminated and the NexStent Carotid Stent System was withdrawn from the market.
Participants by arm
| Arm | Count |
|---|---|
| NexStent Carotid Stent System Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure. | 298 |
| Total | 298 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 12-Months Post-Procedure | Death | 23 |
| 12-Months Post-Procedure | Lost to Follow-up | 4 |
| 12-Months Post-Procedure | Missed Visit | 25 |
| 12-Months Post-Procedure | Visit Not Required by Protocol | 6 |
| 12-Months Post-Procedure | Withdrawal by Subject | 6 |
| 30-Days Post-Procedure | Death | 2 |
| 30-Days Post-Procedure | Missed Visit | 7 |
| 30-Days Post-Procedure | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | NexStent Carotid Stent System |
|---|---|
| Age Continuous | 72.2 Years STANDARD_DEVIATION 9.6 |
| Current Angina None | 243 Participants |
| Current Angina Silent Ischemia | 3 Participants |
| Current Angina Stable Angina | 42 Participants |
| Current Angina Unstable Angina | 10 Participants |
| Current Carotid Bruit Current Carotid Bruit | 175 Participants |
| Current Carotid Bruit No Current Carotid Bruit | 82 Participants |
| Current Carotid Bruit Unknown | 41 Participants |
| History of Atrial Fibrillation/Flutter History of Atrial Fibrillation/Flutter | 50 Participants |
| History of Atrial Fibrillation/Flutter No History of Atrial Fibrillation/Flutter | 241 Participants |
| History of Atrial Fibrillation/Flutter Unknown | 7 Participants |
| History of Carotid Atherosclerosis History of Carotid Atherosclerosis | 187 Participants |
| History of Carotid Atherosclerosis No History of Carotid Atherosclerosis | 101 Participants |
| History of Carotid Atherosclerosis Unknown | 10 Participants |
| History of Carotid Endarterectomy (CEA) History of CEA | 74 Participants |
| History of Carotid Endarterectomy (CEA) No History of CEA | 223 Participants |
| History of Carotid Endarterectomy (CEA) Unknown | 1 Participants |
| History of Carotid Restenosis History of Carotid Restenosis | 49 Participants |
| History of Carotid Restenosis No History of Carotid Restenosis | 246 Participants |
| History of Carotid Restenosis Unknown | 3 Participants |
| History of Cerebrovascular Accident (CVA) History of CVA | 62 Participants |
| History of Cerebrovascular Accident (CVA) No History of CVA | 233 Participants |
| History of Cerebrovascular Accident (CVA) Unknown | 3 Participants |
| History of Congestive Heart Failure (CHF) History of CHF | 54 Participants |
| History of Congestive Heart Failure (CHF) No History of CHF | 241 Participants |
| History of Congestive Heart Failure (CHF) Unknown | 3 Participants |
| History of Coronary Artery Bypass Grafting (CABG) History of CABG | 85 Participants |
| History of Coronary Artery Bypass Grafting (CABG) No History of CABG | 212 Participants |
| History of Coronary Artery Bypass Grafting (CABG) Unknown | 1 Participants |
| History of Coronary Artery Disease (CAD) History of CAD | 196 Participants |
| History of Coronary Artery Disease (CAD) No History of CAD | 94 Participants |
| History of Coronary Artery Disease (CAD) Unknown | 8 Participants |
| History of Diabetes History of Diabetes | 114 Participants |
| History of Diabetes No History of Diabetes | 182 Participants |
| History of Diabetes Unknown | 2 Participants |
| History of Hyperlipidemia History of Hyperlipidemia | 257 Participants |
| History of Hyperlipidemia No History of Hyperlipidemia | 40 Participants |
| History of Hyperlipidemia Unknown | 1 Participants |
| History of Hypertension History of Hypertension | 268 Participants |
| History of Hypertension No History of Hypertension | 29 Participants |
| History of Hypertension Unknown | 1 Participants |
| History of Mantle or Head and Neck Radiation History of Mantle or Head and Neck Radiation | 15 Participants |
| History of Mantle or Head and Neck Radiation No History of Mantle or Head and Neck Radiation | 281 Participants |
| History of Mantle or Head and Neck Radiation Unknown | 2 Participants |
| History of Myocardial Infarction (MI) History of MI | 81 Participants |
| History of Myocardial Infarction (MI) No History of MI | 206 Participants |
| History of Myocardial Infarction (MI) Unknown | 11 Participants |
| History of Percutaneous Coronary Intervention (PCI) History of PCI | 97 Participants |
| History of Percutaneous Coronary Intervention (PCI) No History of PCI | 196 Participants |
| History of Percutaneous Coronary Intervention (PCI) Unknown | 5 Participants |
| History of Percutaneous Transluminal Angioplasty (PTA) History of PTA | 15 Participants |
| History of Percutaneous Transluminal Angioplasty (PTA) No History of PTA | 282 Participants |
| History of Percutaneous Transluminal Angioplasty (PTA) Unknown | 1 Participants |
| History of Peripheral Vascular Disease (PVD) History of PVD | 117 Participants |
| History of Peripheral Vascular Disease (PVD) No History of PVD | 172 Participants |
| History of Peripheral Vascular Disease (PVD) Unknown | 9 Participants |
| History of Seizure History of Seizure | 5 Participants |
| History of Seizure No History of Seizure | 290 Participants |
| History of Seizure Unknown | 3 Participants |
| History of Significant Bleeding History of Significant Bleeding | 11 Participants |
| History of Significant Bleeding No History of Significant Bleeding | 286 Participants |
| History of Significant Bleeding Unknown | 1 Participants |
| History of Smoking Current | 67 Participants |
| History of Smoking Never | 77 Participants |
| History of Smoking Previous | 145 Participants |
| History of Smoking Unknown | 9 Participants |
| History of Transient Ischemic Attack (TIA) History of TIA | 77 Participants |
| History of Transient Ischemic Attack (TIA) No History of TIA | 207 Participants |
| History of Transient Ischemic Attack (TIA) Unknown | 14 Participants |
| History of Upper Extremity Fibromuscular Dysplasia (FMD) History of Upper Extremity FMD | 1 Participants |
| History of Upper Extremity Fibromuscular Dysplasia (FMD) No History of Upper Extremity FMD | 292 Participants |
| History of Upper Extremity Fibromuscular Dysplasia (FMD) Unknown | 5 Participants |
| History of Vertebrobasilar Occlusive Disease History of Vertebrobasilar Occlusive Disease | 11 Participants |
| History of Vertebrobasilar Occlusive Disease No History of Vertebrobasilar Occlusive Disease | 267 Participants |
| History of Vertebrobasilar Occlusive Disease Unknown | 20 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black, of African Heritage | 20 Participants |
| Race/Ethnicity, Customized Caucasian | 258 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 15 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Region of Enrollment United States | 298 Participants |
| Sex: Female, Male Female | 119 Participants |
| Sex: Female, Male Male | 179 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 72 / 298 |
| serious Total, serious adverse events | 150 / 298 |
Outcome results
Primary
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.
Time frame: 12 Months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NexStent Carotid Stent System | Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE) | 12-Month Major Adverse Events (Overall) | 16 Participants |
| NexStent Carotid Stent System | Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE) | Ipsilateral Stroke (31-365 Days) | 4 Participants |
Primary
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.
Time frame: 30 Days
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NexStent Carotid Stent System | Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE) | 30-Day Major Adverse Events (Overall) | 13 Participants |
| NexStent Carotid Stent System | Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE) | Death (0-30 Days) | 3 Participants |
| NexStent Carotid Stent System | Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE) | Stroke (0-30 Days) | 10 Participants |
| NexStent Carotid Stent System | Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE) | MI (0-30 Days) | 3 Participants |