Trial Outcomes & Findings for A Carotid Stenting Boston Scientific Surveillance Program (NCT NCT00741091)
NCT ID: NCT00741091
Last Updated: 2011-08-24
Results Overview
Number of participants who experienced a major adverse event (MAE) 0-30 days post-procedure. MAE was defined as add death, stroke, and myocardial infarction(MI).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1097 participants
Primary outcome timeframe
30 days
Results posted on
2011-08-24
Participant Flow
Enrollment began on 17 December 2008. Enrollment was completed on 28 September 2010.
Participant milestones
| Measure |
Carotid WALLSTENT Endoprothesis and FilterWire EZ System
Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
|
|---|---|
|
Overall Study
STARTED
|
1097
|
|
Overall Study
COMPLETED
|
1040
|
|
Overall Study
NOT COMPLETED
|
57
|
Reasons for withdrawal
| Measure |
Carotid WALLSTENT Endoprothesis and FilterWire EZ System
Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
|
|---|---|
|
Overall Study
Death
|
13
|
|
Overall Study
Lost to Follow-up
|
16
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Missed Visit
|
22
|
Baseline Characteristics
A Carotid Stenting Boston Scientific Surveillance Program
Baseline characteristics by cohort
| Measure |
Carotid WALLSTENT Endoprothesis and FilterWire EZ System
n=1097 Participants
Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
|
|---|---|
|
Age Continuous
|
71.3 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
414 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
683 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1097 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: All 1097 enrolled participants were considered for analysis. A total of 1025 subjects were evaluable for MAEs. Seventy two participants were not evaluable for MAEs; 32 participants were not evaluable because the follow-up occurred less than 23 days from enrollment and 40 participants did not complete the expected follow-up.
Number of participants who experienced a major adverse event (MAE) 0-30 days post-procedure. MAE was defined as add death, stroke, and myocardial infarction(MI).
Outcome measures
| Measure |
Carotid WALLSTENT Endoprothesis and FilterWire EZ System
n=1025 Participants
Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
|
|---|---|
|
Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)
|
47 Participants
|
SECONDARY outcome
Timeframe: 30 daysAdverse events, serious and non-serious, were reported by all study centers. Device related adverse events were defined as any adverse event related the study device as determined by the (Principal Investigator)PI. Procedure related adverse events were defined as any adverse event related the study procedure as determine by the PI. Unrelated adverse events were determined by the PI to not be related to the study device or study procedure.
Outcome measures
| Measure |
Carotid WALLSTENT Endoprothesis and FilterWire EZ System
n=1097 Participants
Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
|
|---|---|
|
Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)
Participants with Device Related AEs
|
139 Participants
|
|
Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)
Participants with Procedure Related AEs
|
486 Participants
|
|
Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)
Participants with Unrelated AEs
|
390 Participants
|
SECONDARY outcome
Timeframe: 30 daysNumber of participant with any surgical or percutaneous attempt to revascularize the target lesion after the initial treatment. The target lesion was defined as the stented segment including 0.5 cm at the proximal and distal margins of the stented segment.
Outcome measures
| Measure |
Carotid WALLSTENT Endoprothesis and FilterWire EZ System
n=1097 Participants
Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
|
|---|---|
|
Target Lesion Revascularization
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: To be evaluable for system technical success, subjects needed to have a Carotid WALLSTENT deployment attempted.
System technical success included successful delivery and deployment of the FilterWire EZ System beyond the target lesion site, delivery and deployment of the Carotid WALLSTENT Endoprosthesis at the intended location, and successful retrieval of the delivery catheter and FilterWire EZ System after stent placement. System technical success rates was calculated based on the number of participants who had both the FilterWire EZ System and Carotid WALLSTENT Endoprosthesis placement attempted.
Outcome measures
| Measure |
Carotid WALLSTENT Endoprothesis and FilterWire EZ System
n=1072 Participants
Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
|
|---|---|
|
System Technical Success
|
1041 Participants
|
SECONDARY outcome
Timeframe: 30 daysDevice Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.
Outcome measures
| Measure |
Carotid WALLSTENT Endoprothesis and FilterWire EZ System
n=1097 Participants
Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
|
|---|---|
|
Device Malfunction
|
61 Devices
|
Adverse Events
Carotid WALLSTENT Endoprothesis and FilterWire EZ System
Serious events: 230 serious events
Other events: 332 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carotid WALLSTENT Endoprothesis and FilterWire EZ System
n=1097 participants at risk
Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
16/1097 • Number of events 16 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Acute coronary syndrome
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Angina pectoris
|
0.73%
8/1097 • Number of events 9 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Angina unstable
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Arrhythmia
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Atrial fibrillation
|
0.36%
4/1097 • Number of events 4 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Atrial flutter
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Bradycardia
|
1.3%
14/1097 • Number of events 14 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Cardiac arrest
|
0.46%
5/1097 • Number of events 5 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Cardiac failure
|
0.27%
3/1097 • Number of events 3 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Cardiac failure congestive
|
0.64%
7/1097 • Number of events 8 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Coronary artery disease
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Myocardial infarction
|
0.46%
5/1097 • Number of events 5 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Sick sinus syndrome
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Sinus arrest
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Sinus bradycardia
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Cardiac disorders
Ventricular tachycardia
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Eye disorders
Blindness
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Eye disorders
Blindness transient
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Eye disorders
Diplopia
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Eye disorders
Eye pain
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Eye disorders
Retinal artery occlusion
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Gastrointestinal disorders
Abdominal pain
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Gastrointestinal disorders
Colitis
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Gastrointestinal disorders
Dysphagia
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Gastrointestinal disorders
Gastritis
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.36%
4/1097 • Number of events 4 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Gastrointestinal disorders
Melaena
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Gastrointestinal disorders
Nausea
|
0.46%
5/1097 • Number of events 5 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Gastrointestinal disorders
Oesophagitis
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Vomiting
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Adverse drug reaction
|
0.27%
3/1097 • Number of events 3 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Asthenia
|
0.36%
4/1097 • Number of events 4 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Catheter site discharge
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Catheter site haematoma
|
0.46%
5/1097 • Number of events 5 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Catheter site haemorrhage
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Catheter site related reaction
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Chills
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Death
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Fatigue
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Gait disturbance
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Generalised oedema
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Multi-organ failure
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Non-cardiac chest pain
|
0.27%
3/1097 • Number of events 3 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Pyrexia
|
0.27%
3/1097 • Number of events 3 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Hepatobiliary disorders
Cholecystitis
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Immune system disorders
Anaphylactic reaction
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Infections and infestations
Appendicitis
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Infections and infestations
Catheter site infection
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Infections and infestations
Cellulitis
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Infections and infestations
Clostridium difficile colitis
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Infections and infestations
Gastroenteritis
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Infections and infestations
Kidney infection
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Infections and infestations
Pneumonia
|
0.64%
7/1097 • Number of events 7 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Infections and infestations
Pneumonia bacterial
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Infections and infestations
Sepsis
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Infections and infestations
Staphylococcal infection
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Infections and infestations
Urinary tract infection
|
0.64%
7/1097 • Number of events 7 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Injury, poisoning and procedural complications
Fall
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Injury, poisoning and procedural complications
Head injury
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.09%
1/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Investigations
Blood creatinine increased
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Investigations
Blood pressure increased
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Investigations
Cardiac stress test abnormal
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Investigations
Electrocardiogram change
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Investigations
Haematocrit decreased
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Investigations
Haemoglobin abnormal
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Investigations
Haemoglobin decreased
|
0.36%
4/1097 • Number of events 4 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Investigations
Troponin increased
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage III
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Aphasia
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Carotid artery occlusion
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.18%
2/1097 • Number of events 3 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Cerebral artery thrombosis
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.09%
1/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Cerebral infarction
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Cerebrovascular accident
|
2.3%
25/1097 • Number of events 25 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Convulsion
|
0.55%
6/1097 • Number of events 6 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Dizziness
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.27%
3/1097 • Number of events 4 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Headache
|
0.27%
3/1097 • Number of events 3 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Hemiparesis
|
0.27%
3/1097 • Number of events 3 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Hemiplegia
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Hypoaesthesia
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Ischaemic stroke
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Presyncope
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Sensory disturbance
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Somnolence
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Syncope
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Syncope vasovagal
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Transient ischaemic attack
|
0.82%
9/1097 • Number of events 9 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Tremor
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Psychiatric disorders
Confusional state
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Psychiatric disorders
Delirium
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Psychiatric disorders
Disorientation
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Psychiatric disorders
Mental status changes
|
0.27%
3/1097 • Number of events 3 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Renal and urinary disorders
Haematuria
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Renal and urinary disorders
Renal failure
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Renal and urinary disorders
Renal failure acute
|
0.46%
5/1097 • Number of events 5 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Renal and urinary disorders
Renal failure chronic
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.36%
4/1097 • Number of events 4 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.46%
5/1097 • Number of events 6 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.27%
3/1097 • Number of events 3 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.27%
3/1097 • Number of events 3 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Surgical and medical procedures
Toe amputation
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Vascular disorders
Aortic aneurysm
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Vascular disorders
Arterial spasm
|
0.18%
2/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Vascular disorders
Arterial thrombosis limb
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Vascular disorders
Deep vein thrombosis
|
0.27%
3/1097 • Number of events 3 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Vascular disorders
Haemorrhage
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Vascular disorders
Hypertension
|
0.36%
4/1097 • Number of events 4 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Vascular disorders
Hypotension
|
4.4%
48/1097 • Number of events 48 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Vascular disorders
Iliac artery stenosis
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Vascular disorders
Orthostatic hypotension
|
0.27%
3/1097 • Number of events 4 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Vascular disorders
Peripheral vascular disorder
|
0.09%
1/1097 • Number of events 2 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Vascular disorders
Shock
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Vascular disorders
Temporal arteritis
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Vascular disorders
Vasospasm
|
0.09%
1/1097 • Number of events 1 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
Other adverse events
| Measure |
Carotid WALLSTENT Endoprothesis and FilterWire EZ System
n=1097 participants at risk
Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
|
|---|---|
|
Cardiac disorders
Bradycardia
|
8.6%
94/1097 • Number of events 97 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Catheter site haematoma
|
6.3%
69/1097 • Number of events 71 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
General disorders
Catheter site haemorrhage
|
5.2%
57/1097 • Number of events 59 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Nervous system disorders
Headache
|
5.3%
58/1097 • Number of events 59 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
|
Vascular disorders
Hypotension
|
14.8%
162/1097 • Number of events 168 • 30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Patients were also evaluated for adverse events during the procedure and at hospital discharge
|
Additional Information
Todd Kornmann, Specialist, Prin Reg Affairs
Boston Scientific Corporation
Phone: 763-494-1348
Email: [email protected]
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 communication 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