Trial Outcomes & Findings for Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions (NCT NCT04175626)
NCT ID: NCT04175626
Last Updated: 2025-04-08
Results Overview
TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).
Recruitment status
ACTIVE_NOT_RECRUITING
Target enrollment
556 participants
Primary outcome timeframe
12-Months
Results posted on
2025-04-08
Participant Flow
Participant milestones
| Measure |
Orsiro Sirolimus Coronary Stent System
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
Overall Study
STARTED
|
556
|
|
Overall Study
COMPLETED
|
531
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
Baseline characteristics by cohort
| Measure |
Orsiro Sirolimus Coronary Stent System
n=556 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 10.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
193 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
363 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
513 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
51 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
452 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
43 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 12-MonthsTLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=531 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure
|
9 Participants
|
SECONDARY outcome
Timeframe: at Hospital Discharge an average of 1 day, at 1 Month, at 1 YearPopulation: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=556 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
All-cause Death
Hospital Discharge
|
1 Participants
|
|
All-cause Death
1 Month
|
2 Participants
|
|
All-cause Death
1 Year
|
6 Participants
|
SECONDARY outcome
Timeframe: at Hospital Discharge an average of 1 day, at 1 Month, at 1 YearPopulation: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=556 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
Protocol-defined Any-vessel Myocardial Infarction
Hospital Discharge
|
3 Participants
|
|
Protocol-defined Any-vessel Myocardial Infarction
1 Month
|
4 Participants
|
|
Protocol-defined Any-vessel Myocardial Infarction
1 Year
|
9 Participants
|
SECONDARY outcome
Timeframe: at Hospital Discharge an average of 1 day, at 1 Month, at 1 YearPopulation: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=556 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
Target Lesion Revascularization (TLR)
Hospital Discharge
|
2 Participants
|
|
Target Lesion Revascularization (TLR)
1 Month
|
3 Participants
|
|
Target Lesion Revascularization (TLR)
1 Year
|
8 Participants
|
SECONDARY outcome
Timeframe: at Hospital Discharge an average of 1 day, at 1 Month, at 1 YearPopulation: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=556 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
Target Vessel Revascularization (TVR)
Hospital Discharge
|
2 Participants
|
|
Target Vessel Revascularization (TVR)
1 Month
|
3 Participants
|
|
Target Vessel Revascularization (TVR)
1 Year
|
15 Participants
|
SECONDARY outcome
Timeframe: at Hospital Discharge an average of 1 day, at 1 Month, at 1 YearPopulation: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=556 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
Cardiac Death or Protocol-defined Any-vessel MI
Hospital Discharge
|
3 Participants
|
|
Cardiac Death or Protocol-defined Any-vessel MI
1 Month
|
4 Participants
|
|
Cardiac Death or Protocol-defined Any-vessel MI
1 Year
|
9 Participants
|
SECONDARY outcome
Timeframe: at Hospital Discharge an average of 1 day, at 1 Month, at 1 YearPopulation: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=556 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
Hospital Discharge TLF Total
|
3 Participants
|
|
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
Hospital Discharge TLF Component: Cardiac Death
|
0 Participants
|
|
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
Hospital Discharge TLF Component: Protocol-defined Target Vessel MI
|
3 Participants
|
|
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
Hospital Discharge TLF Component: Clinically-driven TLR
|
2 Participants
|
|
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
1 Month TLF Total
|
4 Participants
|
|
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
1 Month TLF Component: Cardiac Death
|
0 Participants
|
|
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
1 Month TLF Component: Protocol-defined Target Vessel MI
|
4 Participants
|
|
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
1 Month TLF Component: Clinically-driven TLR
|
2 Participants
|
|
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
1 Year TLF Total
|
9 Participants
|
|
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
1 Year TLF Component: Cardiac Death
|
0 Participants
|
|
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
1 Year TLF Component: Protocol-defined Target Vessel MI
|
7 Participants
|
|
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
1 Year TLF Component: Clinically-driven TLR
|
5 Participants
|
SECONDARY outcome
Timeframe: at Hospital Discharge an average of 1 day, at 1 Month, at 1 YearPopulation: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=556 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
Hospital Discharge TVF Total
|
3 Participants
|
|
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
Hospital Discharge TVF Component: Cardiac Death
|
0 Participants
|
|
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
Hospital Discharge TVF Component: Protocol-defined Target Vessel MI
|
3 Participants
|
|
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
Hospital Discharge TVF Component: Clinically-driven TVR
|
2 Participants
|
|
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
1 Month TVF Total
|
4 Participants
|
|
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
1 Month TVF Component: Cardiac Death
|
0 Participants
|
|
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
1 Month TVF Component: Protocol-defined Target Vessel MI
|
4 Participants
|
|
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
1 Month TVF Component: Clinically-driven TVR
|
2 Participants
|
|
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
1 Year TVF Total
|
14 Participants
|
|
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
1 Year TVF Component: Cardiac Death
|
0 Participants
|
|
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
1 Year TVF Component: Protocol-defined Target Vessel MI
|
7 Participants
|
|
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
1 Year TVF Component: Clinically-driven TVR
|
12 Participants
|
SECONDARY outcome
Timeframe: at Hospital Discharge an average of 1 day, at 1 Month, at 1 YearPopulation: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=556 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
Hospital Discharge MACE Total
|
4 Participants
|
|
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
Hospital Discharge MACE Component: Death
|
1 Participants
|
|
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
Hospital Discharge MACE Component: Protocol-defined Any-Vessel Q Wave or Non-Q Wave MI
|
3 Participants
|
|
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
Hospital Discharge MACE Component: Clinically-driven TLR
|
2 Participants
|
|
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
1 Month MACE Total
|
6 Participants
|
|
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
1 Month MACE Component: Death
|
2 Participants
|
|
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
1 Month MACE Component: Protocol-defined Any-Vessel Q Wave or Non-Q Wave MI
|
4 Participants
|
|
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
1 Month MACE Component: Clinically-driven TLR
|
2 Participants
|
|
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
1 Year MACE Total
|
17 Participants
|
|
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
1 Year MACE Component: Death
|
6 Participants
|
|
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
1 Year MACE Component: Protocol-defined Any-Vessel Q Wave or Non-Q Wave MI
|
9 Participants
|
|
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
1 Year MACE Component: Clinically-driven TLR
|
5 Participants
|
SECONDARY outcome
Timeframe: at 24 Hours, at 1 Month, at 1 YearPopulation: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=556 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
Stent Thrombosis
Any ARC-2 Stent Thrombosis Acute (<=24 hours)
|
1 Participants
|
|
Stent Thrombosis
Any ARC-2 Stent Thrombosis Sub-acute (>24 hours and <=30 days)
|
0 Participants
|
|
Stent Thrombosis
Any ARC-2 Stent Thrombosis Late (>30 days and <=1 year)
|
1 Participants
|
|
Stent Thrombosis
Definite ARC-2 Stent Thrombosis Acute (<=24 hours)
|
1 Participants
|
|
Stent Thrombosis
Definite ARC-2 Stent Thrombosis Sub-acute (>24 hours and <=30 days)
|
0 Participants
|
|
Stent Thrombosis
Definite ARC-2 Stent Thrombosis Late (>30 days and <=1 year)
|
1 Participants
|
|
Stent Thrombosis
Probable ARC-2 Stent Thrombosis Acute (<=24 hours)
|
0 Participants
|
|
Stent Thrombosis
Probable ARC-2 Stent Thrombosis Sub-acute (>24 hours and <=30 days)
|
0 Participants
|
|
Stent Thrombosis
Probable ARC-2 Stent Thrombosis Late (>30 days and <=1 year)
|
0 Participants
|
SECONDARY outcome
Timeframe: at Hospital Discharge an average of 1 dayPopulation: Device Success per lesion. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis.
Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=690 Lesions
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
Number of Lesions With Device Success
|
689 Lesions
|
SECONDARY outcome
Timeframe: at Hospital Discharge an average of 1 dayPopulation: Lesion Success per lesion. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis.
Defined as attainment of \< 30% residual stenosis of the target lesion using any percutaneous method.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=690 Lesions
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
Number of Lesions With Lesion Success
|
689 Lesions
|
SECONDARY outcome
Timeframe: at Hospital Discharge an average of 1 dayPopulation: Procedure success was analyzed per subject: for a subject to be considered a procedure success, all of the subject's target lesions had to be considered device success. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis.
Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only without occurrence of in-hospital major adverse cardiac events (MACE; composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically-driven TLR).
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=556 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
Number of Participants With Procedure Success
|
551 Participants
|
Adverse Events
Orsiro Sirolimus Coronary Stent System
Serious events: 154 serious events
Other events: 58 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Orsiro Sirolimus Coronary Stent System
n=556 participants at risk
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
7/556 • Number of events 7 • 1 Year
|
|
Cardiac disorders
Angina pectoris
|
0.90%
5/556 • Number of events 5 • 1 Year
|
|
Cardiac disorders
Angina unstable
|
1.1%
6/556 • Number of events 6 • 1 Year
|
|
Cardiac disorders
Anginal equivalent
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Arrhythmia ventricular
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
8/556 • Number of events 10 • 1 Year
|
|
Cardiac disorders
Atrial flutter
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Cardiac disorders
Bioprosthetic valvular thrombus
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Cardiac arrest
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Cardiac failure chronic
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
6/556 • Number of events 6 • 1 Year
|
|
Cardiac disorders
Complete heart block
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Coronary artery disease
|
0.54%
3/556 • Number of events 3 • 1 Year
|
|
Cardiac disorders
Coronary artery dissection
|
0.90%
5/556 • Number of events 5 • 1 Year
|
|
Cardiac disorders
Coronary artery restenosis
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Coronary artery stenosis
|
3.1%
17/556 • Number of events 22 • 1 Year
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Ear and labyrinth disorders
Vertigo
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Abdominal distension
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Colitis
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Constipation
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Dysphagia
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Gastrointestinal disorders
Oesophageal motility disorder
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Gastrointestinal disorders
Vomiting
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
General disorders
Alcohol withdrawal
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
General disorders
Altered mental status
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
General disorders
Catheter site haematoma
|
0.54%
3/556 • Number of events 3 • 1 Year
|
|
General disorders
Catheter site haemorrhage
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
General disorders
Chest pain
|
4.3%
24/556 • Number of events 25 • 1 Year
|
|
General disorders
Non-cardiac chest pain
|
0.54%
3/556 • Number of events 3 • 1 Year
|
|
General disorders
Vascular stent restenosis
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
General disorders
Vascular stent thrombosis
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Hepatobiliary disorders
Elevated liver enzyme levels
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Hepatobiliary disorders
Hepatoma
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Hepatobiliary disorders
Liver mass
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Infections and infestations
COVID-19
|
0.72%
4/556 • Number of events 4 • 1 Year
|
|
Infections and infestations
COVID-19 pneumonia
|
1.3%
7/556 • Number of events 7 • 1 Year
|
|
Infections and infestations
Cellulitis
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Infections and infestations
Joint infection
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Infections and infestations
Pneumonia
|
0.90%
5/556 • Number of events 6 • 1 Year
|
|
Infections and infestations
Pyelonephritis
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Infections and infestations
Sepsis
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Infections and infestations
Septic shock
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Infections and infestations
Urinary tract infection
|
1.1%
6/556 • Number of events 9 • 1 Year
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Fall
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Laceration
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Investigations
Ejection fraction decreased
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Investigations
Myocardial necrosis marker increased
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.54%
3/556 • Number of events 3 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoid tumor
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Altered state of conciousness
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Carotid artery disease
|
0.18%
1/556 • Number of events 2 • 1 Year
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Nervous system disorders
Encephalopathy
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Ischaemic stroke
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Myasthenia gravis crisis
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Presyncope
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Nervous system disorders
Sciatica
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Syncope
|
0.54%
3/556 • Number of events 3 • 1 Year
|
|
Nervous system disorders
Vasovegal episode
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Pregnancy, puerperium and perinatal conditions
Delivery
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Psychiatric disorders
Delirium
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Acute kidney injury
|
0.90%
5/556 • Number of events 5 • 1 Year
|
|
Renal and urinary disorders
Bladder prolapse
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Erosion of implanted urethral mesh
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Hematuria
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Renal failure
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Renal mass
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Volume depletion
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragm paralysis
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Posterior pharyngeal wall hypertrophy
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Surgical and medical procedures
Implantable defibrillator replacement
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Surgical and medical procedures
Thymectomy
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Vascular disorders
Aortic aneurysm Type II endoleak
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Vascular disorders
Aortic stenosis
|
0.90%
5/556 • Number of events 5 • 1 Year
|
|
Vascular disorders
Arterial intramural haematoma
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Vascular disorders
Deep vein thrombosis
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Vascular disorders
Femoral artery dissection
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Vascular disorders
Hypertension
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Vascular disorders
Hypotension
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Vascular disorders
Orthostatic hypotension
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Vascular disorders
Peripheral artery stenosis
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Vascular disorders
Peripheral vascular disease
|
0.18%
1/556 • Number of events 1 • 1 Year
|
|
Vascular disorders
Steal syndrome
|
0.36%
2/556 • Number of events 2 • 1 Year
|
|
Vascular disorders
Subclavian artery stenosis
|
0.18%
1/556 • Number of events 1 • 1 Year
|
Other adverse events
| Measure |
Orsiro Sirolimus Coronary Stent System
n=556 participants at risk
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
|---|---|
|
General disorders
Catheter site haematoma
|
1.4%
8/556 • Number of events 8 • 1 Year
|
|
General disorders
Chest pain
|
2.9%
16/556 • Number of events 24 • 1 Year
|
|
Investigations
Myocardial necrosis marker increased
|
6.1%
34/556 • Number of events 36 • 1 Year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place