Trial Outcomes & Findings for ILLUMENATE EU Randomized Clinical Trial (NCT NCT01858363)

Last Updated: 2021-10-13

Results Overview

The primary efficacy endpoint was patency at 12 months post-procedure defined as the absence of target lesion restenosis determined by duplex ultrasound peak systolic velocity ratio (PSVR) ≤2.5 and freedom from clinically-driven target lesion revascularization (CD-TLR).

Recruitment status

COMPLETED

Study phase

Target enrollment

294 participants

Primary outcome timeframe

12 months

Results posted on

2021-10-13

Participant Flow

Unit of analysis: Lesions

Participant milestones

Participant milestones
Measure	Paclitaxel-coated Balloon Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter	Bare Balloon Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. Bare Percutaneous Transluminal Angioplasty Balloon Catheter
Overall Study STARTED	222 254	72 79
Overall Study Pre-discharge Visit	219 251	72 79
Overall Study 1-month Visit	214 246	68 75
Overall Study 6-month Visit	208 239	64 71
Overall Study 12-month Vist	205 235	61 67
Overall Study 24-month Visit	184 209	58 64
Overall Study 36-month Visit	169 194	53 59
Overall Study 48-month Visit	157 179	53 59
Overall Study COMPLETED	146 167	46 51
Overall Study NOT COMPLETED	76 87	26 28

Reasons for withdrawal

Reasons for withdrawal
Measure	Paclitaxel-coated Balloon Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter	Bare Balloon Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. Bare Percutaneous Transluminal Angioplasty Balloon Catheter
Overall Study Death	35	9
Overall Study Withdrawal by Subject	28	14
Overall Study Lost to Follow-up	13	3

Baseline Characteristics

The Rutherford Clinical Category assessment was missing for 1 Paclitaxel-coated Balloon patient and for 1 Bare Balloon patient.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paclitaxel-coated Balloon n=254 lesions Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter	Bare Balloon n=79 lesions Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. Bare Percutaneous Transluminal Angioplasty Balloon Catheter	Total n=333 lesions Total of all reporting groups
Age, Continuous	66.8 years STANDARD_DEVIATION 9.2 • n=222 Participants	69.0 years STANDARD_DEVIATION 8.6 • n=72 Participants	67.3 years STANDARD_DEVIATION 9.1 • n=294 Participants
Sex: Female, Male Female	62 Participants n=222 Participants	23 Participants n=72 Participants	85 Participants n=294 Participants
Sex: Female, Male Male	160 Participants n=222 Participants	49 Participants n=72 Participants	209 Participants n=294 Participants
Rutherford Clinical Category Rutherford Clinical Category 2	34 Participants n=221 Participants • The Rutherford Clinical Category assessment was missing for 1 Paclitaxel-coated Balloon patient and for 1 Bare Balloon patient.	15 Participants n=71 Participants • The Rutherford Clinical Category assessment was missing for 1 Paclitaxel-coated Balloon patient and for 1 Bare Balloon patient.	49 Participants n=292 Participants • The Rutherford Clinical Category assessment was missing for 1 Paclitaxel-coated Balloon patient and for 1 Bare Balloon patient.
Rutherford Clinical Category Rutherford Clinical Category 3	183 Participants n=221 Participants • The Rutherford Clinical Category assessment was missing for 1 Paclitaxel-coated Balloon patient and for 1 Bare Balloon patient.	55 Participants n=71 Participants • The Rutherford Clinical Category assessment was missing for 1 Paclitaxel-coated Balloon patient and for 1 Bare Balloon patient.	238 Participants n=292 Participants • The Rutherford Clinical Category assessment was missing for 1 Paclitaxel-coated Balloon patient and for 1 Bare Balloon patient.
Rutherford Clinical Category Rutherford Clinical Category 4	4 Participants n=221 Participants • The Rutherford Clinical Category assessment was missing for 1 Paclitaxel-coated Balloon patient and for 1 Bare Balloon patient.	1 Participants n=71 Participants • The Rutherford Clinical Category assessment was missing for 1 Paclitaxel-coated Balloon patient and for 1 Bare Balloon patient.	5 Participants n=292 Participants • The Rutherford Clinical Category assessment was missing for 1 Paclitaxel-coated Balloon patient and for 1 Bare Balloon patient.
Diabetes	83 Participants n=222 Participants	26 Participants n=72 Participants	109 Participants n=294 Participants
Hypertension	173 Participants n=222 Participants	60 Participants n=72 Participants	233 Participants n=294 Participants
Hyperlipidemia	137 Participants n=222 Participants	49 Participants n=72 Participants	186 Participants n=294 Participants
Smoking status Never Smoked	24 Participants n=222 Participants	12 Participants n=72 Participants	36 Participants n=294 Participants
Smoking status Previous or current	198 Participants n=222 Participants	60 Participants n=72 Participants	258 Participants n=294 Participants
Baseline Ankle Brachial Index	0.72 ratio STANDARD_DEVIATION 0.21 • n=212 Participants • The ABI is part of the most missed assessments at baseline which accounts for the missing data. For some participants, ABI is non-measurable or the number too high suggesting non-compressible vessels (with a pressure cuff) and thus cannot be reported.	0.69 ratio STANDARD_DEVIATION 0.26 • n=68 Participants • The ABI is part of the most missed assessments at baseline which accounts for the missing data. For some participants, ABI is non-measurable or the number too high suggesting non-compressible vessels (with a pressure cuff) and thus cannot be reported.	0.71 ratio STANDARD_DEVIATION 0.22 • n=280 Participants • The ABI is part of the most missed assessments at baseline which accounts for the missing data. For some participants, ABI is non-measurable or the number too high suggesting non-compressible vessels (with a pressure cuff) and thus cannot be reported.
Lesion length (mm)	71.8 mm STANDARD_DEVIATION 51.9 • n=250 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).	70.8 mm STANDARD_DEVIATION 52.7 • n=79 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).	71.6 mm STANDARD_DEVIATION 52.0 • n=329 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).
Lesion type De novo	234 lesions n=254 lesions	71 lesions n=79 lesions	305 lesions n=333 lesions
Lesion type Restonotic	20 lesions n=254 lesions	8 lesions n=79 lesions	28 lesions n=333 lesions
Total Occlusion	48 lesions n=250 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).	15 lesions n=79 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).	63 lesions n=329 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).
Calcification None/Mild	140 lesions n=251 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).	47 lesions n=79 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).	187 lesions n=330 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).
Calcification Moderate	79 lesions n=251 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).	24 lesions n=79 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).	103 lesions n=330 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).
Calcification Severe	32 lesions n=251 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).	8 lesions n=79 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).	40 lesions n=330 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).
Diameter stenosis	78.7 % Diameter Stenosis STANDARD_DEVIATION 16.0 • n=250 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).	80.8 % Diameter Stenosis STANDARD_DEVIATION 15.7 • n=79 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).	79.2 % Diameter Stenosis STANDARD_DEVIATION 15.9 • n=329 lesions • For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).
Reference vessel Diameter	5.02 mm STANDARD_DEVIATION 0.79 • n=250 lesions • For 3 DCB subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on avalaible images (All other baseline lesion characterics are missing).	4.77 mm STANDARD_DEVIATION 0.69 • n=79 lesions • For 3 DCB subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on avalaible images (All other baseline lesion characterics are missing).	4.96 mm STANDARD_DEVIATION 0.78 • n=329 lesions • For 3 DCB subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites. For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on avalaible images (All other baseline lesion characterics are missing).
# of patent run-off vessels 0	18 Participants n=211 Participants • The lesions characterics are reported as analyzed by angiographic core laboratory by quantitative angiography.	4 Participants n=68 Participants • The lesions characterics are reported as analyzed by angiographic core laboratory by quantitative angiography.	22 Participants n=279 Participants • The lesions characterics are reported as analyzed by angiographic core laboratory by quantitative angiography.
# of patent run-off vessels 1	40 Participants n=211 Participants • The lesions characterics are reported as analyzed by angiographic core laboratory by quantitative angiography.	9 Participants n=68 Participants • The lesions characterics are reported as analyzed by angiographic core laboratory by quantitative angiography.	49 Participants n=279 Participants • The lesions characterics are reported as analyzed by angiographic core laboratory by quantitative angiography.
# of patent run-off vessels 2	68 Participants n=211 Participants • The lesions characterics are reported as analyzed by angiographic core laboratory by quantitative angiography.	31 Participants n=68 Participants • The lesions characterics are reported as analyzed by angiographic core laboratory by quantitative angiography.	99 Participants n=279 Participants • The lesions characterics are reported as analyzed by angiographic core laboratory by quantitative angiography.
# of patent run-off vessels 3	85 Participants n=211 Participants • The lesions characterics are reported as analyzed by angiographic core laboratory by quantitative angiography.	24 Participants n=68 Participants • The lesions characterics are reported as analyzed by angiographic core laboratory by quantitative angiography.	109 Participants n=279 Participants • The lesions characterics are reported as analyzed by angiographic core laboratory by quantitative angiography.
pre-dilatation performed	254 lesions n=254 lesions	78 lesions n=79 lesions	332 lesions n=333 lesions
Body Mass Index (BMI)	27.2 kg/m^2 STANDARD_DEVIATION 4.7 • n=218 Participants • BMI data was not available for 4 participants in the Paclitaxel-coated balloon group.	27.8 kg/m^2 STANDARD_DEVIATION 4.7 • n=72 Participants • BMI data was not available for 4 participants in the Paclitaxel-coated balloon group.	27.3 kg/m^2 STANDARD_DEVIATION 4.7 • n=290 Participants • BMI data was not available for 4 participants in the Paclitaxel-coated balloon group.

PRIMARY outcome

Timeframe: 12 months

Population: The analysis for the primary patency was based on the lesion success and not participant success. In the Paclitaxel-coated balloon arm, 222 subjects represents 254 lesions. Of those 254 lesions, only 224 lesions were evaluable. In the Bare balloon arm, 72 subjects represents 79 lesions. Of those 79 lesions, only 66 lesions were evaluable.

Outcome measures

Outcome measures
Measure	Paclitaxel-coated Balloon n=224 lesions Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter	Bare Balloon n=66 lesions Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. Bare Percutaneous Transluminal Angioplasty Balloon Catheter
Patency at 12-months	83.9 percentage of lesions Interval 78.5 to 88.5	60.6 percentage of lesions Interval 47.8 to 72.4

PRIMARY outcome

Timeframe: 30-Days and 12-Months

The primary safety endpoint was freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 12 months post-procedure.

Outcome measures

Outcome measures
Measure	Paclitaxel-coated Balloon n=222 Participants Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter	Bare Balloon n=72 Participants Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. Bare Percutaneous Transluminal Angioplasty Balloon Catheter
Percentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month	94.1 percentage of participants Interval 90.0 to 96.9	83.3 percentage of participants Interval 71.5 to 91.7

Adverse Events

Paclitaxel-coated Balloon

Serious events: 118 serious events

Other events: 180 other events

Deaths: 35 deaths

Bare Balloon

Serious events: 38 serious events

Other events: 51 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

Additional Information

Nicolas Aguirre

Spectranetics

Phone: +1-312-297-6655

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Paclitaxel-coated Balloon n=219 participants at risk Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter	Bare Balloon n=68 participants at risk Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. Bare Percutaneous Transluminal Angioplasty Balloon Catheter
Blood and lymphatic system disorders ANAEMIA	1.4% 3/219 • Number of events 3 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.91% 2/219 • Number of events 2 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders ANGINA PECTORIS	0.91% 2/219 • Number of events 2 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders ANGINA UNSTABLE	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders ARTERIOSCLEROSIS CORONARY ARTERY	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders ATRIAL FIBRILLATION	1.4% 3/219 • Number of events 3 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders ATRIAL FLUTTER	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders BRADYCARDIA	0.46% 1/219 • Number of events 3 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders CARDIAC ARREST	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders CARDIAC FAILURE	0.91% 2/219 • Number of events 2 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders CORONARY ARTERY DISEASE	4.1% 9/219 • Number of events 11 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders CORONARY ARTERY STENOSIS	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders MYOCARDIAL INFARCTION	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Congenital, familial and genetic disorders ENDOCARDIAL FIBROELASTOSIS	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Eye disorders CATARACT	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Eye disorders EYELID PTOSIS	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Eye disorders LENS DISLOCATION	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Eye disorders MACULAR DEGENERATION	0.91% 2/219 • Number of events 2 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Eye disorders RETINAL ARTERY OCCLUSION	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Eye disorders RETINAL DETACHMENT	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders COLITIS	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders COLITIS ULCERATIVE	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders CONSTIPATION	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders CROHN'S DISEASE	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders DYSPEPSIA	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders HAEMATOCHEZIA	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders HAEMORRHOIDS	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders INGUINAL HERNIA	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders INTESTINAL ISCHAEMIA	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders LARGE INTESTINAL ULCER	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders LARGE INTESTINE POLYP	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders NAUSEA	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders PANCREATITIS	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders PANCREATITIS CHRONIC	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	2.9% 2/68 • Number of events 5 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders PROCTITIS	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.

Other adverse events
Measure	Paclitaxel-coated Balloon n=219 participants at risk Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter	Bare Balloon n=68 participants at risk Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. Bare Percutaneous Transluminal Angioplasty Balloon Catheter
General disorders PUNCTURE SITE HAEMORRHAGE	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
General disorders THROMBOSIS IN DEVICE	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Hepatobiliary disorders BILIARY CIRRHOSIS PRIMARY	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Hepatobiliary disorders CHOLELITHIASIS	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Hepatobiliary disorders CHOLESTASIS	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 2 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Hepatobiliary disorders HEPATIC CIRRHOSIS	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Hepatobiliary disorders HEPATIC FAILURE	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Hepatobiliary disorders LIVER DISORDER	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Immune system disorders HYPERSENSITIVITY	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Infections and infestations BRONCHITIS	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Blood and lymphatic system disorders ANAEMIA	1.8% 4/219 • Number of events 4 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Blood and lymphatic system disorders EOSINOPHILIA	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.91% 2/219 • Number of events 2 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.91% 2/219 • Number of events 2 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders ANGINA PECTORIS	1.4% 3/219 • Number of events 3 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders ANGINA UNSTABLE	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders ARRHYTHMIA	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders ARTERIOSCLEROSIS CORONARY ARTERY	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders ATRIAL FIBRILLATION	1.8% 4/219 • Number of events 4 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders ATRIAL FLUTTER	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders BRADYCARDIA	0.46% 1/219 • Number of events 3 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders CARDIAC ARREST	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders CARDIAC FAILURE	1.4% 3/219 • Number of events 4 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders CORONARY ARTERY DISEASE	4.6% 10/219 • Number of events 14 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders CORONARY ARTERY STENOSIS	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders MYOCARDIAL INFARCTION	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Cardiac disorders TACHYCARDIA	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Congenital, familial and genetic disorders ENDOCARDIAL FIBROELASTOSIS	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Ear and labyrinth disorders CERUMEN IMPACTION	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Ear and labyrinth disorders VERTIGO	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Endocrine disorders HYPERTHYROIDISM	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Eye disorders CATARACT	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 2 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Eye disorders CHORIORETINOPATHY	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Eye disorders DIABETIC RETINOPATHY	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Eye disorders EYELID PTOSIS	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Eye disorders LENS DISLOCATION	0.00% 0/219 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	1.5% 1/68 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Eye disorders MACULAR DEGENERATION	0.91% 2/219 • Number of events 2 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.
Eye disorders RETINAL ARTERY OCCLUSION	0.46% 1/219 • Number of events 1 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.	0.00% 0/68 • The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device.