Trial Outcomes & Findings for VISSIT Intracranial Stent Study for Ischemic Therapy (NCT NCT00816166)
NCT ID: NCT00816166
Last Updated: 2015-02-20
Results Overview
The primary effectiveness endpoint was a composite of the two following outcomes: * Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization * Hard Transient Ischemic Attack (TIA) in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization A subject was deemed to be a primary endpoint success if neither of these outcomes occurred. The Kaplan-Meier success rate at 12-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of last follow-up, and the time variable for patients who were not successful (had a stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of the first event (stroke with 12 months or hard TIA between 2 days and 12 months).
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
125 participants
Primary outcome timeframe
One Year
Results posted on
2015-02-20
Participant Flow
Subjects were screened and enrolled at 27 sites worldwide (23 sites in the US and 4 sites outside of the US).
125 consented,of which 112 were randomized.Of 112,110 were treated (64 Stent Arm \& 46 Med Therapy \[MT\] Arm).Of 112, 111 met criteria \& in analysis pop (58 Stent Arm \& 53 MT Arm).During course of the study,of 59 randomized to Stent Arm,4 treated w/MT Only \& 1 failed to meet eligibility \& excluded, \& of 53 randomized to MT Arm, 9 treated w/Stent+MT.
Participant milestones
| Measure |
Stent Group
Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")
Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions.
|
Medical Therapy Group
Medical therapy alone ("Medical Therapy Group")
Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
53
|
|
Overall Study
ITT Population (Met Eligibility)
|
58
|
53
|
|
Overall Study
COMPLETED
|
49
|
41
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
| Measure |
Stent Group
Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")
Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions.
|
Medical Therapy Group
Medical therapy alone ("Medical Therapy Group")
Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
10
|
|
Overall Study
Death
|
4
|
2
|
Baseline Characteristics
VISSIT Intracranial Stent Study for Ischemic Therapy
Baseline characteristics by cohort
| Measure |
Stent Group
n=58 Participants
Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")
Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions.
|
Medical Therapy Group
n=53 Participants
Medical therapy alone ("Medical Therapy Group")
Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
42 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Region of Enrollment
China
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One YearPopulation: Analyses were based on an intent-to-treat (ITT) population, defined as enrolled subjects who met the inclusion/exclusion criteria and who were randomized post angiogram. Stent and Medical Therapy Group subjects were analyzed according to their ITT randomized group regardless of treatment received.
The primary effectiveness endpoint was a composite of the two following outcomes: * Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization * Hard Transient Ischemic Attack (TIA) in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization A subject was deemed to be a primary endpoint success if neither of these outcomes occurred. The Kaplan-Meier success rate at 12-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of last follow-up, and the time variable for patients who were not successful (had a stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of the first event (stroke with 12 months or hard TIA between 2 days and 12 months).
Outcome measures
| Measure |
Stent Group
n=58 Participants
Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")
Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions.
|
Medical Therapy Group
n=53 Participants
Medical therapy alone ("Medical Therapy Group")
Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)
|
|---|---|---|
|
Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months
|
62.24 percent probability
Interval 48.15 to 73.15
|
83.68 percent probability
Interval 69.94 to 91.5
|
Adverse Events
Stent Group
Serious events: 30 serious events
Other events: 37 other events
Deaths: 0 deaths
Medical Therapy Group
Serious events: 20 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stent Group
n=58 participants at risk
Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")
Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions.
|
Medical Therapy Group
n=53 participants at risk
Medical therapy alone ("Medical Therapy Group")
Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
3.8%
2/53 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Chest pain
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
3.8%
2/53 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Oedema peripheral
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Syncope
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Ear and labyrinth disorders
Vertigo
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Endocrine disorders
Hyperglycaemia
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Endocrine disorders
Hypoglycaemia
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Haematochezia
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
General disorders
Completed suicide
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
General disorders
Death
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
General disorders
Medical device pain
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
General disorders
Neurological symptom
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
General disorders
Stent malfunction
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Infections and infestations
Cellulitis
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
3.8%
2/53 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Infections and infestations
Infection
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Injury, poisoning and procedural complications
Vascular rupture
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Ataxia
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Cerebral infarction
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Cerebral ischaemia
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Cerebrovascular accident
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Convulsion
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Haemorrhagic stroke
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Ischaemic stroke
|
12.1%
7/58 • Number of events 7 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
7.5%
4/53 • Number of events 4 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Muscular weakness
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Neurological symptom
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Post procedural stroke
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
3.8%
2/53 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Vision blurred
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Visual field defect
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Psychiatric disorders
Panic attack
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Psychiatric disorders
Suicide attempt
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Renal and urinary disorders
Urinary retention
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Renal and urinary disorders
Urinary tract infection
|
5.2%
3/58 • Number of events 3 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Surgical and medical procedures
Amputation
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Surgical and medical procedures
Carotid endarterectomy
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Artery dissection
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Hypertension
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Hypotension
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Intermittent claudication
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Migraine
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Peripheral vascular disorder
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Transient ischaemic attack
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
7.5%
4/53 • Number of events 5 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
Other adverse events
| Measure |
Stent Group
n=58 participants at risk
Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")
Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions.
|
Medical Therapy Group
n=53 participants at risk
Medical therapy alone ("Medical Therapy Group")
Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)
|
|---|---|---|
|
Vascular disorders
Transient ischaemic attack
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
15.1%
8/53 • Number of events 12 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Vasospasm
|
6.9%
4/58 • Number of events 4 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Venous thrombosis
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Blood and lymphatic system disorders
Anaemia
|
5.2%
3/58 • Number of events 3 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
3.8%
2/53 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Blood and lymphatic system disorders
Haemoglobin decreased
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Bradycardia
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Chest discomfort
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Chest pain
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
3.8%
2/53 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Coronary Artery Disease
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Dizziness
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Dizziness postural
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Myocardial ischaemia
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Oedema peripheral
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Presyncope
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Syncope
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Ear and labyrinth disorders
Vertigo
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
3.8%
2/53 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Endocrine disorders
Diabetic neuropathy
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Endocrine disorders
Diabetic retinopathy
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Endocrine disorders
Hyperglycaemia
|
5.2%
3/58 • Number of events 3 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Endocrine disorders
Hypoglycaemia
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Eye disorders
Eye pain
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Eye disorders
Visual field defect
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Abdominal distension
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Barrett s oesophagus
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Constipation
|
8.6%
5/58 • Number of events 5 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Eye disorders
Dysphagia
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
3.8%
2/53 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Gastrointestinal disorders
Post procedural diarrhoea
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
General disorders
Fatigue
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
General disorders
Influenza like illness
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
General disorders
Lethargy
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
General disorders
Localised oedema
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
General disorders
Malaise
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
General disorders
Neurological complication associated with device
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
General disorders
Pain
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
General disorders
Pyrexia
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Infections and infestations
Herpes zoster
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Infections and infestations
Infection
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Infections and infestations
Oral candidiasis
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Injury, poisoning and procedural complications
Fall
|
10.3%
6/58 • Number of events 6 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
7.5%
4/53 • Number of events 4 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Injury, poisoning and procedural complications
Phlebitis
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Investigations
Blood creatine increased
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Investigations
Blood glucose fluctuation
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Investigations
Blood glucose increased
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Investigations
Blood potassium abnormal
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Investigations
Blood potassium decreased
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Investigations
Blood testosterone decreased
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Investigations
Hepatic enzyme increased
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Investigations
Neurological examination abnormal
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Investigations
Radial pulse decreased
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Investigations
Transaminases increased
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.2%
3/58 • Number of events 3 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.2%
3/58 • Number of events 3 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Musculoskeletal and connective tissue disorders
Joint dislocation
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Musculoskeletal and connective tissue disorders
Wrist fracture
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Aphasia
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Carpal tunnel syndrome
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Diabetic gastroparesis
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Diplopia
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Dysarthria
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Headache
|
6.9%
4/58 • Number of events 5 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
5.7%
3/53 • Number of events 4 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Hemiparesis
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Ischaemic stroke
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Neuralgia
|
3.4%
2/58 • Number of events 3 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Paraesthesia
|
5.2%
3/58 • Number of events 4 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
3.8%
2/53 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Post stroke depression
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Procedural headache
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Somnolence
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Nervous system disorders
Vision blurred
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Psychiatric disorders
Confusional state
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Psychiatric disorders
Depression
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Psychiatric disorders
Memory impairment
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Psychiatric disorders
Withdrawal syndrome
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Renal and urinary disorders
Dysuria
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Renal and urinary disorders
Micturition urgency
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Renal and urinary disorders
Post procedural haematuria
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Renal and urinary disorders
Renal cyst
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Renal and urinary disorders
Renal failure acute
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Renal and urinary disorders
Urinary Retention
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Renal and urinary disorders
Urinary tract infection
|
8.6%
5/58 • Number of events 5 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Reproductive system and breast disorders
Breast Mass
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Respiratory, thoracic and mediastinal disorders
Radiation pneumonitis
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
3.8%
2/53 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.2%
3/58 • Number of events 3 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
3.8%
2/53 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Surgical and medical procedures
Cataract operation
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Surgical and medical procedures
Tooth extraction
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Artery dissection
|
3.4%
2/58 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Contusion
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Epistaxis
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Haematoma
|
0.00%
0/58 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
3.8%
2/53 • Number of events 2 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Hypertension
|
12.1%
7/58 • Number of events 9 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
13.2%
7/53 • Number of events 10 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Hypotension
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Orthostatic hypotension
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Post procedural haematoma
|
5.2%
3/58 • Number of events 4 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Post procedural haemorrhage
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
1.9%
1/53 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
|
Vascular disorders
Subclavian artery stenosis
|
1.7%
1/58 • Number of events 1 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
0.00%
0/53 • Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse events collected and were summarized according to how they were reported by investigational sites
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60