Trial Outcomes & Findings for Trial Comparing ELUVIA Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery (NCT NCT02921230)
NCT ID: NCT02921230
Last Updated: 2025-02-24
Results Overview
The primary effectiveness endpoint assesses primary patency at 12 months post-procedure. This effectiveness endpoint is designed to demonstrate that the 12-month primary patency for the ELUVIA treatment group is superior to the Self-Expanding Bare Nitinol Stents treatment group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
775 participants
Primary outcome timeframe
12 Months
Results posted on
2025-02-24
Participant Flow
Over an enrollment period of 41 months, 775 subjects were enrolled in the study of which, 508 subjects were enrolled in the investigational test device arm and 267 were enrolled in the bare metal stent (control device).
Participant milestones
| Measure |
ELUVIA Stent Implantation
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Overall Study
STARTED
|
508
|
267
|
|
Overall Study
COMPLETED
|
453
|
249
|
|
Overall Study
NOT COMPLETED
|
55
|
18
|
Reasons for withdrawal
| Measure |
ELUVIA Stent Implantation
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
20
|
8
|
|
Overall Study
Death
|
12
|
3
|
|
Overall Study
Protocol Violation
|
17
|
6
|
|
Overall Study
Early completion
|
5
|
1
|
|
Overall Study
Pending data entry
|
1
|
0
|
Baseline Characteristics
Trial Comparing ELUVIA Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery
Baseline characteristics by cohort
| Measure |
ELUVIA Stent Implantation
n=508 Participants
Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=267 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
Total
n=775 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
68.9 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
68.9 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
363 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
543 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black of African Heritage
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
434 Participants
n=5 Participants
|
234 Participants
n=7 Participants
|
668 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
55 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
53 participants
n=5 Participants
|
28 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=5 Participants
|
6 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
71 participants
n=5 Participants
|
40 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
45 participants
n=5 Participants
|
24 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
15 participants
n=5 Participants
|
10 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
France
|
73 participants
n=5 Participants
|
34 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
18 participants
n=5 Participants
|
12 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
206 participants
n=5 Participants
|
106 participants
n=7 Participants
|
312 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
13 participants
n=5 Participants
|
6 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
History of Smoking
Current
|
183 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
History of Smoking
Never
|
91 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
History of Smoking
Previous
|
201 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
History of Smoking
Unknown
|
33 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Current Diabetes Mellitus
|
180 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
History of Hyperlipidemia requiring medication
|
341 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
523 Participants
n=5 Participants
|
|
History of Hypertension requiring medication
|
397 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
600 Participants
n=5 Participants
|
|
History of Chronic Obstructive Pulmonary Disease
|
65 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
History of Coronary Artery Disease
|
159 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
History of Myocardial Infarction (MI)
|
75 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
History of Congestive Heart Failure
|
35 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
History of Percutaneous Coronary Intervention (PCI)
|
114 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
History of Coronary Artery Bypass Graft (CABG) Surgery
|
50 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Current Anginal Status
Stable Angina
|
19 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Current Anginal Status
None
|
482 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
732 Participants
n=5 Participants
|
|
Current Anginal Status
Unknown
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Current Anginal Status
Unstable Angina
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
History of Transient Ischemic Attacks (TIA)
|
29 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
History of Cerebrovascular Accident (CVA)
|
38 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
History of Renal Insufficiency
|
59 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
History of Renal Percutaneous Intervention
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
History of Endovascular Interventions in Target Vessel
|
36 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
History of Other Peripheral Endovascular Interventions (other than Target Vessel)
|
147 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
History of Claudication
|
447 Participants
n=5 Participants
|
228 Participants
n=7 Participants
|
675 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Primary patency defined as core-lab assessed duplex ultrasound peak systolic velocity ratio (PSVR) ≤ 2.4 at 12 months in the absence of clinically-driven Target Lesion Revascularization (TLR) or bypass of the target lesion. 405/508 subjects in Eluvia and 222/267 subjects in the control arm.
The primary effectiveness endpoint assesses primary patency at 12 months post-procedure. This effectiveness endpoint is designed to demonstrate that the 12-month primary patency for the ELUVIA treatment group is superior to the Self-Expanding Bare Nitinol Stents treatment group.
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=405 Participants
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=222 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Number of Subjects With Primary Patency at 12 Months Post-procedure
|
337 Participants
|
165 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsWalking Improvement will be assessed and compared between the 2 study arms, by evaluating the change in Six Minute Hall Walk (6MHW) / treadmill test from baseline, or preceding any Target Vessel Revascularization and evaluating change in Walking Impairment Questionnaire (WIQ) from baseline. Values are represented as a mean and standard deviation and reflect the change in meters walked.
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=508 Participants
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=267 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Number of Subjects Walking Improvement - Distance at Baseline to 12 Months
Baseline
|
258.4 Meter
Standard Deviation 153.4
|
239.1 Meter
Standard Deviation 150.0
|
|
Number of Subjects Walking Improvement - Distance at Baseline to 12 Months
12 Month
|
392.4 Meter
Standard Deviation 286.0
|
361.9 Meter
Standard Deviation 176.2
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: The number analyzed for each row is based on the number of subjects that completed the portion of the quality-of-life assessment during the visit.
The change in quality of life will be assessed and compared between the 2 study arms, by evaluating change in EuroQol (EQ) - 5 Dimensions (5D) - 5 Levels (5L) questionnaire (EQ-5D-5L™) from baseline, or preceding any Target Vessel Revascularization Values are presented as a count of subjects at 12-months and by the number of subjects analyzed.
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=445 Participants
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=246 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month
Anxiety/ Depression Improvement
|
100 Participants
|
49 Participants
|
|
Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month
Mobility Improvement
|
295 Participants
|
158 Participants
|
|
Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month
Self-Care Improvement
|
39 Participants
|
19 Participants
|
|
Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month
Usual Activities Improvement
|
169 Participants
|
91 Participants
|
|
Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month
Pain/ Discomfort Improvement
|
238 Participants
|
143 Participants
|
SECONDARY outcome
Timeframe: during index procedure, 1, 6, 12, 24 and 36 monthsPopulation: Cost effectiveness was not collected for the study as this data was an optional health economics data analysis.
Cost effectiveness of ELUVIA™ drug-eluting stent versus bare metal self-expanding nitinol stents.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsClinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline. Values are presented as a count of participants at 12-months by the number of participants analyzed. Rutherford Classification describes 7 categories of peripheral artery disease, including both the patient's clinical symptoms as well as objective findings; Primary sustained clinical improvement, is a rate of improvement in Rutherford classification of one or more categories as compared to baseline without the need for repeat target lesion revascularization (TLR); Secondary sustained clinical improvement is a rate of improvement in Rutherford classification of one or more categories as compared to baseline including those subjects with repeat TLR; Clinical deterioration, is the rate of downgrade in Rutherford classification of one or more categories as compared to baseline
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=440 Participants
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=244 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Number of Subjects With Clinical Improvement at 12-months
Primary Sustained Clinical Improvement - Improvement in Rutherford Classification without TLR
|
365 Participants
|
187 Participants
|
|
Number of Subjects With Clinical Improvement at 12-months
Secondary Sustained Clinical Improvement - Improvement in Rutherford Classification with TLR
|
396 Participants
|
211 Participants
|
|
Number of Subjects With Clinical Improvement at 12-months
No Change from Baseline
|
40 Participants
|
30 Participants
|
|
Number of Subjects With Clinical Improvement at 12-months
Clinical Deterioration
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 monthsHemodynamic improvement was evaluated by assessing the number of participants that demonstrated an increase in the Ankle-Brachial Index value of \>/= 0.10 or an increase in the overall ABI value to \>/= 0.90 from baseline to 12 months
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=419 Participants
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=233 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Number of Subjects With Hemodynamic Improvement at 12-months
Hemodynamic Improvement
|
331 Participants
|
179 Participants
|
|
Number of Subjects With Hemodynamic Improvement at 12-months
Hemodynamic Improvement - Including TLR
|
355 Participants
|
196 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1, 6, 12, 24, and 36 monthsPopulation: The number analyzed for each row is based on the number of subjects that completed the assessment during the specified visit.
Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months assessed by change in Walking Impairment Questionnaire (WIQ) from baseline.
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=508 Participants
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=267 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
6 Month - Speed Scores - Number of Subjects Improved
|
335 Participants
|
180 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
6 Month - Stair Climbing Scores - Number of Subjects Improved
|
309 Participants
|
164 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
12 Month - PAD Specific Question - Number of Subjects Improved
|
360 Participants
|
184 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
1 Month - PAD Specific Question - Number of Subjects Improved
|
297 Participants
|
158 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
1 Month - Distance Score - Number of Subjects Improved
|
299 Participants
|
162 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
1 Month - Speed Scores - Number of Subjects Improved
|
270 Participants
|
140 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
1 Month - Stair Climbing Scores - Number of Subjects Improved
|
238 Participants
|
133 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
6 Month - PAD Specific Question - Number of Subjects Improved
|
366 Participants
|
195 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
6 Month - Distance Score - Number of Subjects Improved
|
381 Participants
|
216 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
12 Month - Distance Score - Number of Subjects Improved
|
372 Participants
|
204 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
12 Month - Speed Scores - Number of Subjects Improved
|
321 Participants
|
173 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
12 Month - Stair Climbing Scores - Number of Subjects Improved
|
300 Participants
|
159 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
24 Month - PAD Specific Question - Number of Subjects Improved
|
317 Participants
|
170 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
24 Month - Distance Score - Number of Subjects Improved
|
344 Participants
|
188 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
24 Month - Speed Scores - Number of Subjects Improved
|
289 Participants
|
149 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
24 Month - Stair Climbing Scores - Number of Subjects Improved
|
269 Participants
|
143 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
36 Month - PAD Specific Question - Number of Subjects Improved
|
298 Participants
|
164 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
36 Month - Distance Score - Number of Subjects Improved
|
304 Participants
|
178 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
36 Month - Speed Scores - Number of Subjects Improved
|
256 Participants
|
135 Participants
|
|
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
36 Month - Stair Climbing Scores - Number of Subjects Improved
|
243 Participants
|
123 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1, 6, 24, and 36 monthsPopulation: The number analyzed for each row is based on the number of subjects that completed the assessment during the specified visit.
Quality of Life Improvement will be assessed at 1-month, 6-months, 24-months, and 36-months by evaluating the change in EQ-5D-5L™ from baseline
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=508 Participants
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=267 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
1 Month - Mobility Improvement
|
257 Participants
|
137 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
1 Month - Self Care Improvement
|
30 Participants
|
11 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
1 Month - Usual Activities Improvement
|
130 Participants
|
76 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
1 Month - Pain/ Discomfort Improvement
|
217 Participants
|
120 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
1 Month - Anxiety/ Depression Improvement
|
70 Participants
|
35 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
6 Month - Mobility Improvement
|
307 Participants
|
162 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
6 Month - Self Care Improvement
|
41 Participants
|
18 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
6 Month - Usual Activities Improvement
|
168 Participants
|
95 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
6 Month - Pain/ Discomfort Improvement
|
258 Participants
|
142 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
6 Month - Anxiety/ Depression Improvement
|
86 Participants
|
53 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
24 Month - Mobility Improvement
|
269 Participants
|
148 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
24 Month - Self Care Improvement
|
32 Participants
|
18 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
24 Month - Usual Activities Improvement
|
149 Participants
|
86 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
24 Month - Pain/ Discomfort Improvement
|
211 Participants
|
137 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
24 Month - Anxiety/ Depression Improvement
|
89 Participants
|
51 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
36 Month - Mobility Improvement
|
238 Participants
|
136 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
36 Month - Self Care Improvement
|
30 Participants
|
15 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
36 Month - Usual Activities Improvement
|
136 Participants
|
78 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
36 Month - Pain/ Discomfort Improvement
|
191 Participants
|
104 Participants
|
|
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
36 Month - Anxiety/ Depression Improvement
|
76 Participants
|
42 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1, 6, 24, and 36 monthsPopulation: The number analyzed for each row is based on the number of subjects that completed the assessment during the specified visit.
Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=508 Participants
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=267 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
1 Month - Primary Sustained Clinical Improvement
|
328 Participants
|
175 Participants
|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
1 Month - Secondary Sustained Clinical Improvement
|
329 Participants
|
176 Participants
|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
1 Month - No Change from Baseline
|
22 Participants
|
13 Participants
|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
1 Month - Clinical Deterioration
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
6 Month - Primary Sustained Clinical Improvement
|
403 Participants
|
223 Participants
|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
6 Month - Secondary Sustained Clinical Improvement
|
415 Participants
|
227 Participants
|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
6 Month - No Change from Baseline
|
35 Participants
|
17 Participants
|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
6 Month - Clinical Deterioration
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
24 Month - Primary Sustained Clinical Improvement
|
304 Participants
|
170 Participants
|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
24 Month - Secondary Sustained Clinical Improvement
|
356 Participants
|
201 Participants
|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
24 Month - No Change from Baseline
|
35 Participants
|
24 Participants
|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
24 Month - Clinical Deterioration
|
8 Participants
|
1 Participants
|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
36 Month - Primary Sustained Clinical Improvement
|
263 Participants
|
152 Participants
|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
36 Month - Secondary Sustained Clinical Improvement
|
336 Participants
|
188 Participants
|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
36 Month - No Change from Baseline
|
35 Participants
|
22 Participants
|
|
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
36 Month - Clinical Deterioration
|
8 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1, 6, 24, and 36 monthsPopulation: The number analyzed for each row is based on the number of subjects that completed the assessment during the specified visit.
The hemodynamic improvement will be evaluated by assessing changes in Ankle-Brachial Index (ABI) from baseline
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=508 Participants
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=267 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months
1 Month - Hemodynamic Improvement
|
287 Participants
|
163 Participants
|
|
Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months
1 Month - Hemodynamic Improvement (Including TLR)
|
288 Participants
|
164 Participants
|
|
Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months
6 Month - Hemodynamic Improvement
|
355 Participants
|
196 Participants
|
|
Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months
6 Month - Hemodynamic Improvement (Including TLR)
|
366 Participants
|
200 Participants
|
|
Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months
24 Month - Hemodynamic Improvement
|
248 Participants
|
145 Participants
|
|
Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months
24 Month - Hemodynamic Improvement (Including TLR)
|
293 Participants
|
166 Participants
|
|
Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months
36 Month - Hemodynamic Improvement
|
215 Participants
|
123 Participants
|
|
Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months
36 Month - Hemodynamic Improvement (Including TLR)
|
272 Participants
|
154 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 monthsPopulation: The number analyzed indicates the subjects with available diagnostic duplex ultrasound images.
Primary Patency and Assisted Primary Patency at 6 months, 12 months using different Duplex Ultrasound (DUS) and Peak Systolic Velocity Ration (PSVRs). All DUS readings will be assessed by an independent core laboratory. Primary Patency is reported at 6 and 12-months.
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=508 Participants
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=267 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Primary Patency and Assisted Primary Patency
6 Month - Primary Patency
|
395 Participants
|
195 Participants
|
|
Primary Patency and Assisted Primary Patency
6 Month - Assisted Primary Patency
|
409 Participants
|
200 Participants
|
|
Primary Patency and Assisted Primary Patency
12 Month - Primary Patency
|
337 Participants
|
165 Participants
|
|
Primary Patency and Assisted Primary Patency
12 Month - Assisted Primary Patency
|
360 Participants
|
182 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1, 6, 12, 24, and 36 monthsPopulation: The number Started in Participant Flow indicates the intent-to-treat population while the number analyzed indicates the as-treated (AT) population. For AT analysis, subjects implanted are included based on the actual Test or Control device each subject received (including cross-over subjects). Only study permitted stents are included in the AT set. The number analyzed in the data table differs from the overall analyzed as it indicates subjects that reached the lower limit for the visit window.
Adverse Event rate and Major Adverse Event rate, defined as all causes of death, target limb major amputation and/or Target Lesion Revascularization, rate at each time point
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=492 Participants
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=273 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Adverse Event and Major Adverse Event (MAE) Rate
1 Month Adverse Event Rate
|
77 Participants
|
32 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
6 Month Adverse Event Rate
|
105 Participants
|
54 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
12 Month Adverse Event Rate
|
134 Participants
|
79 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
24 Month Adverse Event Rate
|
181 Participants
|
96 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
36 Month Adverse Event Rate
|
215 Participants
|
111 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
1 Month - MAE - All Cause Death
|
3 Participants
|
0 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
1 Month - MAE - Target Limb Major Amputation
|
1 Participants
|
0 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
1 Month - MAE - Target Lesion Revascularization
|
2 Participants
|
2 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
6 Month - MAE - All Cause Death
|
7 Participants
|
3 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
6 Month - MAE - Target Limb Major Amputation
|
1 Participants
|
0 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
6 Month - MAE - Target Lesion Revascularization
|
23 Participants
|
7 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
12 Month - MAE - All Cause Death
|
13 Participants
|
3 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
12 Month - MAE - Target Limb Major Amputation
|
1 Participants
|
0 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
12 Month - MAE - Target Lesion Revascularization
|
42 Participants
|
28 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
24 Month - MAE - All Cause Death
|
28 Participants
|
8 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
24 Month - MAE - Target Limb Major Amputation
|
1 Participants
|
0 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
24 Month - MAE - Target Lesion Revascularization
|
71 Participants
|
45 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
36 Month - MAE - All Cause Death
|
38 Participants
|
15 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
36 Month - MAE - Target Limb Major Amputation
|
2 Participants
|
1 Participants
|
|
Adverse Event and Major Adverse Event (MAE) Rate
36 Month - MAE - Target Lesion Revascularization
|
100 Participants
|
53 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1, 6, 12, 24, and 36 monthsPopulation: The number started in participant flow indicates the intent-to-treat population while the number analyzed indicates the the as-treated population. For as-treated analysis, all subjects in the per-protocol population will be included based on the actual Test or Control device that each subject received (i.e. including cross-over subjects). The number analyzed in the rows below differs from the overall analyzed as it indicates the subjects that reached the lower limit for the visit window.
Target Lesion Revascularization, defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure, rate at each time point.
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=492 Participants
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=273 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Clinically-driven Target Lesion Revascularization (TLR) Rate
1 Month - Clinically-driven TLR
|
3 Participants
|
2 Participants
|
|
Clinically-driven Target Lesion Revascularization (TLR) Rate
6 Month - Clinically-driven TLR
|
23 Participants
|
7 Participants
|
|
Clinically-driven Target Lesion Revascularization (TLR) Rate
12 Month - Clinically-driven TLR
|
40 Participants
|
28 Participants
|
|
Clinically-driven Target Lesion Revascularization (TLR) Rate
24 Month - Clinically-driven TLR
|
69 Participants
|
45 Participants
|
|
Clinically-driven Target Lesion Revascularization (TLR) Rate
36 Month - Clinically-driven TLR
|
97 Participants
|
53 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1, 6, 12, 24 and 36 monthsPopulation: The number analyzed indicates the subjects that reached the lower limit for the visit window.
Target Vessel Revascularization, defined as any surgical or percutaneous intervention to the target vessel after the index procedure, rate at each time point.
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=492 Participants
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=273 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Clinically-driven Target Vessel Revascularization (TVR) Rate
1 Month - Clinically-driven TVR
|
4 Participants
|
4 Participants
|
|
Clinically-driven Target Vessel Revascularization (TVR) Rate
6 Month - Clinically-driven TVR
|
26 Participants
|
10 Participants
|
|
Clinically-driven Target Vessel Revascularization (TVR) Rate
12 Month - Clinically-driven TVR
|
52 Participants
|
30 Participants
|
|
Clinically-driven Target Vessel Revascularization (TVR) Rate
24 Month - Clinically-driven TVR
|
77 Participants
|
48 Participants
|
|
Clinically-driven Target Vessel Revascularization (TVR) Rate
36 Month - Clinically-driven TVR
|
105 Participants
|
56 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: during index procedure after stent delivered and deployed to the target lesionPopulation: The number started in participant flow indicates the intent-to-treat population while the number analyzed indicates the the as-treated population. For as-treated analysis, all subjects in the per-protocol population will be included based on the actual Test or Control device that each subject received (i.e. including cross-over subjects).
Technical success defined as delivery and deployment of the assigned study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% assessed visually
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=491 Participants
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=273 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Technical Success
|
488 Participants
|
269 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: within 24 hours of stenting procedurePopulation: The number started in participant flow indicates the intent-to-treat population while the number analyzed indicates the the as-treated population. For as-treated analysis, all subjects in the per-protocol population will be included based on the actual Test or Control device that each subject received (i.e. including cross-over subjects).
Procedural success defined as technical success with no MAEs noted within 24 hours of the index procedure
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=491 Participants
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=273 Participants
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Procedural Success
|
488 Participants
|
269 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 MonthsNumber of Stent Fractures reported at 12 months utilizing the Vascular InterVentional Advances (VIVA) definitions assessed by an independent core laboratory. Stent fractures were analyzed if sites collected imaging per standard of care (SOC).
Outcome measures
| Measure |
ELUVIA Stent Implantation
n=21 Stents
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=16 Stents
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Number of Stent Fractures
|
1 Stents
|
2 Stents
|
Adverse Events
ELUVIA Stent Implantation
Serious events: 181 serious events
Other events: 109 other events
Deaths: 39 deaths
Control Bare Metal Stent Implantation
Serious events: 90 serious events
Other events: 54 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
ELUVIA Stent Implantation
n=492 participants at risk
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=273 participants at risk
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Vascular disorders
Peripheral artery occlusion
|
6.5%
32/492 • Number of events 40 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
1.8%
5/273 • Number of events 6 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Peripheral artery stenosis
|
6.5%
32/492 • Number of events 38 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
6.2%
17/273 • Number of events 19 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Intermittent claudication
|
2.2%
11/492 • Number of events 12 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
1.1%
3/273 • Number of events 3 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Peripheral ischaemia
|
1.0%
5/492 • Number of events 5 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.61%
3/492 • Number of events 4 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Haematoma
|
0.41%
2/492 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Peripheral embolism
|
0.41%
2/492 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Thrombosis
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Arterial disorder
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Extremity necrosis
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Reperfusion injury
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Vascular dissection
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Femoral artery dissection
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.73%
2/273 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Vascular stent restenosis
|
4.3%
21/492 • Number of events 21 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
7.0%
19/273 • Number of events 28 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Vascular stent thrombosis
|
2.4%
12/492 • Number of events 14 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
2.2%
6/273 • Number of events 6 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Vascular stent stenosis
|
2.0%
10/492 • Number of events 11 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
3.7%
10/273 • Number of events 11 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Death
|
2.2%
11/492 • Number of events 11 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
2.2%
6/273 • Number of events 6 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Impaired healing
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Necrosis
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Stenosis
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
1.5%
4/273 • Number of events 4 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Device embolisation
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.4%
7/492 • Number of events 7 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
1.5%
4/273 • Number of events 4 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Reocclusion
|
1.2%
6/492 • Number of events 6 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
1.8%
9/492 • Number of events 9 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
3.3%
9/273 • Number of events 13 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Arterial bypass occlusion
|
0.20%
1/492 • Number of events 3 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.41%
2/492 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Vascular access site pseudoaneurysm
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Product Issues
Device occlusion
|
4.1%
20/492 • Number of events 23 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
2.2%
6/273 • Number of events 6 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Infections and infestations
Pneumonia
|
1.2%
6/492 • Number of events 6 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Infections and infestations
Localised infection
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Infections and infestations
Post procedural sepsis
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.41%
2/492 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.41%
2/492 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.73%
2/273 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Cardiac disorders
Myocardial infarction
|
0.81%
4/492 • Number of events 4 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.41%
2/492 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Nervous system disorders
Cerebral infarction
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Psychiatric disorders
Completed Suicide
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Arterial haemorrhage
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Venous stenosis
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Vascular stent occlusion
|
1.8%
9/492 • Number of events 11 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.73%
2/273 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
General physical health deterioration
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Inflammation
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Sudden death
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
0.61%
3/492 • Number of events 3 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Infections and infestations
Corona virus infection
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Infections and infestations
Gangrene
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Cardiac disorders
Cardiac failure
|
0.61%
3/492 • Number of events 3 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Cardiac disorders
Cardiac disorder
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic interstitial pneumonia
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Psychiatric disorders
Depression
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Aneurysm
|
0.41%
2/492 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Infections and infestations
Sepsis
|
0.41%
2/492 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
Other adverse events
| Measure |
ELUVIA Stent Implantation
n=492 participants at risk
Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
|
Control Bare Metal Stent Implantation
n=273 participants at risk
Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
|
|---|---|---|
|
Vascular disorders
Peripheral artery stenosis
|
2.2%
11/492 • Number of events 13 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
2.6%
7/273 • Number of events 7 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Peripheral artery occlusion
|
2.2%
11/492 • Number of events 12 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
1.8%
5/273 • Number of events 5 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Haematoma
|
1.0%
5/492 • Number of events 5 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
1.5%
4/273 • Number of events 4 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Vascular dissection
|
0.81%
4/492 • Number of events 4 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Femoral artery dissection
|
0.61%
3/492 • Number of events 3 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
2.2%
6/273 • Number of events 6 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Artery dissection
|
0.41%
2/492 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Deep vein thrombosis
|
0.41%
2/492 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Aneurysm
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Arterial spasm
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Haemorrhage
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.41%
2/492 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Peripheral embolism
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Thrombosis
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Vascular occlusion
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Vascular disorders
Arteriovenus fistula
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Vascular stent restenosis
|
1.8%
9/492 • Number of events 9 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
4.4%
12/273 • Number of events 12 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Vascular stent stenosis
|
1.0%
5/492 • Number of events 5 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
1.5%
4/273 • Number of events 4 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Vessel puncture site haematoma
|
0.81%
4/492 • Number of events 4 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
1.1%
3/273 • Number of events 3 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Vascular stent thrombosis
|
1.0%
5/492 • Number of events 5 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Stenosis
|
0.41%
2/492 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.73%
2/273 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Puncture site haemorrhage
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.73%
2/273 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Oedema peripheral
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Puncture site pain
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Device embolisation
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
2.0%
10/492 • Number of events 10 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.73%
2/273 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.41%
2/492 • Number of events 2 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
1.2%
6/492 • Number of events 6 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
1.1%
3/273 • Number of events 3 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Postoperative thrombosis
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Reocclusion
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Product Issues
Device occlusion
|
1.2%
6/492 • Number of events 6 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
1.8%
5/273 • Number of events 5 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Skin and subcutaneous tissue disorders
Skin maceration
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Immune system disorders
Contrast media allergy
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/492 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.37%
1/273 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Inflammation
|
1.4%
7/492 • Number of events 7 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
General disorders
Vascular stent occlusion
|
1.4%
7/492 • Number of events 7 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
0.20%
1/492 • Number of events 1 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
0.00%
0/273 • Adverse event data were collected up to 36 months follow up.
All-cause mortality is analyzed for the ITT population. Safety endpoints included SAE and Other (not Including Serious) Adverse Events, is analyzed for the As-treated (AT) population. Subjects who receive either ELUVIA or bare metal stents (BMS) at procedure are included in the AT analysis set according to the treatment actually received (even if not the treatment they were randomized to). Subjects who do not receive ELUVIA or study permitted BMS are excluded from the AT analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER