Trial Outcomes & Findings for Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMA (NCT NCT00478673)

NCT ID: NCT00478673

Last Updated: 2012-08-07

Results Overview

30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 298 participants
• Primary outcome timeframe: 30 Days
• Results posted on: 2012-08-07

Participant Flow

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 On June 17, 2008, enrollment was terminated and the NexStent Carotid Stent System was withdrawn from the market.

Participant milestones

Measure	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.
30-Days Post-Procedure STARTED	298
30-Days Post-Procedure COMPLETED	288
30-Days Post-Procedure NOT COMPLETED	10
12-Months Post-Procedure STARTED	295
12-Months Post-Procedure COMPLETED	231
12-Months Post-Procedure NOT COMPLETED	64

Reasons for withdrawal

Measure	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.
30-Days Post-Procedure Death	2
30-Days Post-Procedure Withdrawal by Subject	1
30-Days Post-Procedure Missed Visit	7
12-Months Post-Procedure Death	23
12-Months Post-Procedure Lost to Follow-up	4
12-Months Post-Procedure Withdrawal by Subject	6
12-Months Post-Procedure Missed Visit	25
12-Months Post-Procedure Visit Not Required by Protocol	6

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	NexStent Carotid Stent System n=298 Participants 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.
Age Continuous	72.2 Years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	119 Participants n=5 Participants
Sex: Female, Male Male	179 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	15 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	258 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Black, of African Heritage	20 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Region of Enrollment United States	298 Participants n=5 Participants
Current Carotid Bruit Current Carotid Bruit	175 Participants n=5 Participants
Current Carotid Bruit No Current Carotid Bruit	82 Participants n=5 Participants
Current Carotid Bruit Unknown	41 Participants n=5 Participants
History of Carotid Atherosclerosis History of Carotid Atherosclerosis	187 Participants n=5 Participants
History of Carotid Atherosclerosis No History of Carotid Atherosclerosis	101 Participants n=5 Participants
History of Carotid Atherosclerosis Unknown	10 Participants n=5 Participants
History of Transient Ischemic Attack (TIA) History of TIA	77 Participants n=5 Participants
History of Transient Ischemic Attack (TIA) No History of TIA	207 Participants n=5 Participants
History of Transient Ischemic Attack (TIA) Unknown	14 Participants n=5 Participants
History of Cerebrovascular Accident (CVA) History of CVA	62 Participants n=5 Participants
History of Cerebrovascular Accident (CVA) No History of CVA	233 Participants n=5 Participants
History of Cerebrovascular Accident (CVA) Unknown	3 Participants n=5 Participants
History of Vertebrobasilar Occlusive Disease History of Vertebrobasilar Occlusive Disease	11 Participants n=5 Participants
History of Vertebrobasilar Occlusive Disease No History of Vertebrobasilar Occlusive Disease	267 Participants n=5 Participants
History of Vertebrobasilar Occlusive Disease Unknown	20 Participants n=5 Participants
History of Seizure History of Seizure	5 Participants n=5 Participants
History of Seizure No History of Seizure	290 Participants n=5 Participants
History of Seizure Unknown	3 Participants n=5 Participants
History of Carotid Endarterectomy (CEA) History of CEA	74 Participants n=5 Participants
History of Carotid Endarterectomy (CEA) No History of CEA	223 Participants n=5 Participants
History of Carotid Endarterectomy (CEA) Unknown	1 Participants n=5 Participants
History of Percutaneous Transluminal Angioplasty (PTA) History of PTA	15 Participants n=5 Participants
History of Percutaneous Transluminal Angioplasty (PTA) No History of PTA	282 Participants n=5 Participants
History of Percutaneous Transluminal Angioplasty (PTA) Unknown	1 Participants n=5 Participants
History of Carotid Restenosis History of Carotid Restenosis	49 Participants n=5 Participants
History of Carotid Restenosis No History of Carotid Restenosis	246 Participants n=5 Participants
History of Carotid Restenosis Unknown	3 Participants n=5 Participants
History of Upper Extremity Fibromuscular Dysplasia (FMD) History of Upper Extremity FMD	1 Participants n=5 Participants
History of Upper Extremity Fibromuscular Dysplasia (FMD) No History of Upper Extremity FMD	292 Participants n=5 Participants
History of Upper Extremity Fibromuscular Dysplasia (FMD) Unknown	5 Participants n=5 Participants
History of Coronary Artery Disease (CAD) History of CAD	196 Participants n=5 Participants
History of Coronary Artery Disease (CAD) No History of CAD	94 Participants n=5 Participants
History of Coronary Artery Disease (CAD) Unknown	8 Participants n=5 Participants
History of Myocardial Infarction (MI) History of MI	81 Participants n=5 Participants
History of Myocardial Infarction (MI) No History of MI	206 Participants n=5 Participants
History of Myocardial Infarction (MI) Unknown	11 Participants n=5 Participants
History of Congestive Heart Failure (CHF) History of CHF	54 Participants n=5 Participants
History of Congestive Heart Failure (CHF) No History of CHF	241 Participants n=5 Participants
History of Congestive Heart Failure (CHF) Unknown	3 Participants n=5 Participants
Current Angina Stable Angina	42 Participants n=5 Participants
Current Angina Unstable Angina	10 Participants n=5 Participants
Current Angina Silent Ischemia	3 Participants n=5 Participants
Current Angina None	243 Participants n=5 Participants
History of Percutaneous Coronary Intervention (PCI) History of PCI	97 Participants n=5 Participants
History of Percutaneous Coronary Intervention (PCI) No History of PCI	196 Participants n=5 Participants
History of Percutaneous Coronary Intervention (PCI) Unknown	5 Participants n=5 Participants
History of Coronary Artery Bypass Grafting (CABG) History of CABG	85 Participants n=5 Participants
History of Coronary Artery Bypass Grafting (CABG) No History of CABG	212 Participants n=5 Participants
History of Coronary Artery Bypass Grafting (CABG) Unknown	1 Participants n=5 Participants
History of Atrial Fibrillation/Flutter History of Atrial Fibrillation/Flutter	50 Participants n=5 Participants
History of Atrial Fibrillation/Flutter No History of Atrial Fibrillation/Flutter	241 Participants n=5 Participants
History of Atrial Fibrillation/Flutter Unknown	7 Participants n=5 Participants
History of Smoking Current	67 Participants n=5 Participants
History of Smoking Previous	145 Participants n=5 Participants
History of Smoking Never	77 Participants n=5 Participants
History of Smoking Unknown	9 Participants n=5 Participants
History of Diabetes History of Diabetes	114 Participants n=5 Participants
History of Diabetes No History of Diabetes	182 Participants n=5 Participants
History of Diabetes Unknown	2 Participants n=5 Participants
History of Hyperlipidemia History of Hyperlipidemia	257 Participants n=5 Participants
History of Hyperlipidemia No History of Hyperlipidemia	40 Participants n=5 Participants
History of Hyperlipidemia Unknown	1 Participants n=5 Participants
History of Hypertension History of Hypertension	268 Participants n=5 Participants
History of Hypertension No History of Hypertension	29 Participants n=5 Participants
History of Hypertension Unknown	1 Participants n=5 Participants
History of Peripheral Vascular Disease (PVD) History of PVD	117 Participants n=5 Participants
History of Peripheral Vascular Disease (PVD) No History of PVD	172 Participants n=5 Participants
History of Peripheral Vascular Disease (PVD) Unknown	9 Participants n=5 Participants
History of Significant Bleeding History of Significant Bleeding	11 Participants n=5 Participants
History of Significant Bleeding No History of Significant Bleeding	286 Participants n=5 Participants
History of Significant Bleeding Unknown	1 Participants n=5 Participants
History of Mantle or Head and Neck Radiation History of Mantle or Head and Neck Radiation	15 Participants n=5 Participants
History of Mantle or Head and Neck Radiation No History of Mantle or Head and Neck Radiation	281 Participants n=5 Participants
History of Mantle or Head and Neck Radiation Unknown	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.

Outcome measures

Measure	NexStent Carotid Stent System n=293 Participants 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.
Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE) 30-Day Major Adverse Events (Overall)	13 Participants
Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE) Death (0-30 Days)	3 Participants Interval 2.4 to 7.5
Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE) Stroke (0-30 Days)	10 Participants
Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE) MI (0-30 Days)	3 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	NexStent Carotid Stent System n=235 Participants 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.
Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE) 12-Month Major Adverse Events (Overall)	16 Participants
Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE) Ipsilateral Stroke (31-365 Days)	4 Participants

Adverse Events

NexStent Carotid Stent System

Serious events: 150 serious events

Other events: 72 other events

Deaths: 0 deaths

Serious adverse events

Measure	NexStent Carotid Stent System n=298 participants at risk 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.
Blood and lymphatic system disorders Anaemia	4.7% 14/298 • Number of events 14 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Blood and lymphatic system disorders Thrombocytopenia	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Cardiac disorders Angina pectoris	2.3% 7/298 • Number of events 11 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Cardiac disorders Atrial fibrillation	2.3% 7/298 • Number of events 8 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Cardiac disorders Atrial flutter	1.0% 3/298 • Number of events 3 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Cardiac disorders Atrial tachycardia	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Cardiac disorders Atrioventricular block complete	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Cardiac disorders Bradycardia	2.0% 6/298 • Number of events 6 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Cardiac disorders Cardiac arrest	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Cardiac disorders Cardiac failure	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Cardiac disorders Cardiac failure acute	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Cardiac disorders Cardiac failure congestive	4.0% 12/298 • Number of events 18 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Cardiac disorders Coronary artery disease	1.0% 3/298 • Number of events 3 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Cardiac disorders Diastolic dysfunction	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Cardiac disorders Myocardial infarction	2.7% 8/298 • Number of events 10 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Cardiac disorders Supraventricular extrasystoles	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Cardiac disorders Ventricular tachycardia	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Ear and labyrinth disorders Vertigo	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Eye disorders Blindness transient	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Gastrointestinal disorders Abdominal pain	1.0% 3/298 • Number of events 3 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Gastrointestinal disorders Abdominal strangulated hernia	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Gastrointestinal disorders Colitis microscopic	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Gastrointestinal disorders Constipation	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Gastrointestinal disorders Diarrhoea	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Gastrointestinal disorders Gastric ulcer	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.3% 4/298 • Number of events 4 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Gastrointestinal disorders Gastrointestinal ulcer haemorrhage	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Gastrointestinal disorders Nausea	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Gastrointestinal disorders Retroperitoneal haemorrhage	1.0% 3/298 • Number of events 3 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Gastrointestinal disorders Vomiting	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
General disorders Adverse drug reaction	0.34% 1/298 • Number of events 3 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
General disorders Asthenia	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
General disorders Death	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
General disorders Gait disturbance	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
General disorders Non-cardiac chest pain	4.0% 12/298 • Number of events 13 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
General disorders Oedema peripheral	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
General disorders Pyrexia	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
General disorders Swelling	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Arthritis bacterial	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Bronchitis	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Candidiasis	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Cellulitis	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Cellulitis staphylococcal	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Chest wall abscess	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Clostridium difficile colitis	0.34% 1/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Influenza	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Osteomyelitis	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Pneumonia	2.7% 8/298 • Number of events 8 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Post procedural infection	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Respiratory tract infection	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Sepsis	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Septic shock	1.0% 3/298 • Number of events 4 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Urinary tract infection	1.7% 5/298 • Number of events 5 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Infections and infestations Urinary tract infection enterococcal	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Injury, poisoning and procedural complications Cephalhaematoma	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Injury, poisoning and procedural complications Facial bones fracture	0.34% 1/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Injury, poisoning and procedural complications Fall	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Injury, poisoning and procedural complications Hip fracture	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Injury, poisoning and procedural complications Injury	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Injury, poisoning and procedural complications Joint injury	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Injury, poisoning and procedural complications Post procedural haematoma	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Injury, poisoning and procedural complications Procedural hypotension	1.3% 4/298 • Number of events 4 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Investigations Blood creatinine increased	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Investigations Blood glucose abnormal	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Investigations Haemoglobin decreased	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Metabolism and nutrition disorders Dehydration	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Metabolism and nutrition disorders Diabetic foot	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Metabolism and nutrition disorders Electrolyte imbalance	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Metabolism and nutrition disorders Failure to thrive	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Metabolism and nutrition disorders Gout	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Metabolism and nutrition disorders Hypoglycaemia	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Metabolism and nutrition disorders Hypokalaemia	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Metabolism and nutrition disorders Hyponatraemia	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Musculoskeletal and connective tissue disorders Arthralgia	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Musculoskeletal and connective tissue disorders Bursitis	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Musculoskeletal and connective tissue disorders Muscle spasms	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Musculoskeletal and connective tissue disorders Muscular weakness	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Altered state of consciousness	0.34% 1/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Carotid artery dissection	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Carotid artery stenosis	5.4% 16/298 • Number of events 18 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Carotid artery thrombosis	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Cerebellar haemorrhage	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Cerebral haemorrhage	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Cerebral infarction	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Cerebrovascular accident	2.3% 7/298 • Number of events 7 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Convulsion	1.0% 3/298 • Number of events 3 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Dizziness	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Embolic stroke	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Haemorrhage intracranial	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Haemorrhagic stroke	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Hypoaesthesia	0.34% 1/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Intention tremor	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Intracranial aneurysm	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Intracranial hypotension	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Lethargy	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Partial seizures	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Postictal paralysis	0.34% 1/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Syncope	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Nervous system disorders Transient ischaemic attack	2.7% 8/298 • Number of events 8 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Psychiatric disorders Conversion disorder	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Renal and urinary disorders Haematuria	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Renal and urinary disorders Renal artery stenosis	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Renal and urinary disorders Renal failure	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Renal and urinary disorders Renal failure acute	1.7% 5/298 • Number of events 6 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Renal and urinary disorders Renal failure chronic	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Renal and urinary disorders Renal hypertension	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Renal and urinary disorders Stress urinary incontinence	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Reproductive system and breast disorders Vaginal haemorrhage	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.4% 10/298 • Number of events 12 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 6/298 • Number of events 6 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Respiratory, thoracic and mediastinal disorders Emphysema	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.0% 3/298 • Number of events 3 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.0% 3/298 • Number of events 3 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.0% 6/298 • Number of events 6 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Vascular disorders Aortic aneurysm	1.0% 3/298 • Number of events 3 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Vascular disorders Arterial occlusive disease	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Vascular disorders Deep vein thrombosis	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Vascular disorders Femoral arterial stenosis	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Vascular disorders Haematoma	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Vascular disorders Hypertensive crisis	0.67% 2/298 • Number of events 2 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Vascular disorders Hypotension	6.7% 20/298 • Number of events 20 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Vascular disorders Iliac artery stenosis	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Vascular disorders Orthostatic hypotension	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Vascular disorders Peripheral arterial occlusive disease	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Vascular disorders Peripheral ischaemia	1.3% 4/298 • Number of events 5 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Vascular disorders Peripheral vascular disorder	1.0% 3/298 • Number of events 4 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Vascular disorders Subclavian artery stenosis	0.34% 1/298 • Number of events 1 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Vascular disorders Vascular pseudoaneurysm	1.0% 3/298 • Number of events 4 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.

Other adverse events

Measure	NexStent Carotid Stent System n=298 participants at risk 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.
Nervous system disorders Carotid artery stenosis	17.8% 53/298 • Number of events 54 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.
Vascular disorders Hypotension	8.1% 24/298 • Number of events 26 • Adverse event data were collected through the 12-month follow-up evaluation. Data reported here represent the total study experience. Subjects were evaluated for adverse events during the procedure, at hospital discharge and at each follow-up visit.

Additional Information

Jim Taufen, Regulatory Affairs Manager

Boston Scientific Corporation

Phone: 763-255-0683

Email: taufenj@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication to remove any confidential information or other proprietary information of Sponsor.
• Publication restrictions are in place

Restriction type: OTHER