Trial Outcomes & Findings for The OMEGA Clinical Trial (NCT NCT01419171)
NCT ID: NCT01419171
Last Updated: 2014-09-25
Results Overview
The primary endpoint is 9-month target lesion failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), Myocardial Infarction (MI) (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
328 participants
Primary outcome timeframe
Nine Month
Results posted on
2014-09-25
Participant Flow
Participant milestones
| Measure |
OMEGA™ Monorail Coronary Stent System
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
Overall Study
STARTED
|
328
|
|
Overall Study
COMPLETED
|
328
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The OMEGA Clinical Trial
Baseline characteristics by cohort
| Measure |
OMEGA™ Monorail Coronary Stent System
n=328 Participants
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
Age, Continuous
|
65.46 years
STANDARD_DEVIATION 11.23 • n=93 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
222 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black, of African heritage
|
9 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
254 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Not disclosed
|
61 participants
n=93 Participants
|
|
Region of Enrollment
France
|
55 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
104 participants
n=93 Participants
|
|
Region of Enrollment
Spain
|
39 participants
n=93 Participants
|
|
Region of Enrollment
Belgium
|
37 participants
n=93 Participants
|
|
Region of Enrollment
Netherlands
|
39 participants
n=93 Participants
|
|
Region of Enrollment
Latvia
|
23 participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
31 participants
n=93 Participants
|
|
Cardiac History
Previous Myocardial Infarction
|
96 participants
n=93 Participants
|
|
Cardiac History
History of CABG
|
15 participants
n=93 Participants
|
|
Cardiac History
History of PCI
|
95 participants
n=93 Participants
|
|
Cardiac History
History of CHF
|
21 participants
n=93 Participants
|
|
Cardiac History
Stable Angina
|
182 participants
n=93 Participants
|
|
Cardiac History
Unstable Angina
|
111 participants
n=93 Participants
|
|
Cardiac History
Silent Ischemia
|
54 participants
n=93 Participants
|
|
Cardiac Risk Factors
Smoking, Ever
|
211 participants
n=93 Participants
|
|
Cardiac Risk Factors
Medically Treated Diabetes
|
57 participants
n=93 Participants
|
|
Cardiac Risk Factors
Hyperlipidemia Requiring Medication
|
230 participants
n=93 Participants
|
|
Cardiac Risk Factors
Hypertension Requiring Medication
|
243 participants
n=93 Participants
|
|
Cardiac Risk Factors
Family History of CAD
|
131 participants
n=93 Participants
|
|
Lesion Characteristics: Target Lesion Vessel
Left Anterior Descending Artery
|
112 participants
n=93 Participants
|
|
Lesion Characteristics: Target Lesion Vessel
Circumflex Artery
|
79 participants
n=93 Participants
|
|
Lesion Characteristics: Target Lesion Vessel
Right Coronary Artery
|
137 participants
n=93 Participants
|
|
Lesion Characteristic: Lesion Location
Proximal
|
122 Lesions
n=93 Participants
|
|
Lesion Characteristic: Lesion Location
Mid
|
155 Lesions
n=93 Participants
|
|
Lesion Characteristic: Lesion Location
Distal
|
37 Lesions
n=93 Participants
|
|
Lesion Characteristic: Lesion Location
Ostial
|
14 Lesions
n=93 Participants
|
|
Lesion Characteristic: Lesion Length
Less than 10 mm
|
123 Lesions
n=93 Participants
|
|
Lesion Characteristic: Lesion Length
10 to 20 mm
|
172 Lesions
n=93 Participants
|
|
Lesion Characteristic: Lesion Length
Greater than 20 mm
|
32 Lesions
n=93 Participants
|
|
Lesion Characteristics
Tortuosity, Any
|
32 Lesions
n=93 Participants
|
|
Lesion Characteristics
Thrombus
|
4 Lesions
n=93 Participants
|
|
Lesion Characteristics
Calcification, Any
|
111 Lesions
n=93 Participants
|
|
Lesion Characteristics
Ulcer
|
21 Lesions
n=93 Participants
|
|
Lesion Characteristics
Aneurysm
|
7 Lesions
n=93 Participants
|
|
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
0 (no perfusion)
|
0 Lesions
n=93 Participants
|
|
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
1 (penetration with minimal perfusion)
|
2 Lesions
n=93 Participants
|
|
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
2 (partial perfusion)
|
6 Lesions
n=93 Participants
|
|
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
3 (complete perfusion)
|
319 Lesions
n=93 Participants
|
|
Lesion Characteristics by Quantitative Cornary Angiography
Reference Vessel Diameter
|
2.77 Millimeters
STANDARD_DEVIATION 0.53 • n=93 Participants
|
|
Lesion Characteristics by Quantitative Cornary Angiography
Minimum Lumen Diameter
|
0.9 Millimeters
STANDARD_DEVIATION 0.38 • n=93 Participants
|
|
Lesion Characteristics by Quantitative Cornary Angiography
Lesion Length
|
12.49 Millimeters
STANDARD_DEVIATION 5.15 • n=93 Participants
|
|
Lesion Characteristic: Percent Diameter Stenosis by QCA
|
67.41 Percent
STANDARD_DEVIATION 11.34 • n=93 Participants
|
PRIMARY outcome
Timeframe: Nine MonthPopulation: N=323 (5 patients were not evaluable for the endpoint: Follow-up \< 240 days and event-free)
The primary endpoint is 9-month target lesion failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), Myocardial Infarction (MI) (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
Outcome measures
| Measure |
OMEGA™ Monorail Coronary Stent System
n=323 Participants
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
9-month Target Lesion Failure (TLF) Rate
|
11.5 percentage of participants
Interval 8.2 to 15.4
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 monthsPopulation: 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.
Any ischemia-driven repeat percutaneous coronary intervention (PCI), to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
Outcome measures
| Measure |
OMEGA™ Monorail Coronary Stent System
n=322 Participants
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
12 Month Target Lesion Revascularization (TLR) Rate
|
8.4 percentage of participants
Interval 5.6 to 12.0
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 monthsPopulation: 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.
Outcome measures
| Measure |
OMEGA™ Monorail Coronary Stent System
n=322 Participants
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
12 Month Target Vessel Revascularization (TVR) Rate
|
9.9 percentage of participants
Interval 6.9 to 13.7
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 monthsPopulation: 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.
Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
Outcome measures
| Measure |
OMEGA™ Monorail Coronary Stent System
n=322 Participants
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
12 Month Target Vessel Failure (TVF) Rate
|
13.8 percentage of participants
Interval 10.2 to 18.0
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 monthsPopulation: 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.
Outcome measures
| Measure |
OMEGA™ Monorail Coronary Stent System
n=322 Participants
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
12 Month Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate
|
4.0 percentage of participants
Interval 2.2 to 6.8
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 monthsPopulation: 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.
Outcome measures
| Measure |
OMEGA™ Monorail Coronary Stent System
n=322 Participants
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
12 Month Cardiac Death Rate
|
1.2 percentage of participants
Interval 0.3 to 3.1
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 monthsPopulation: 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.
Outcome measures
| Measure |
OMEGA™ Monorail Coronary Stent System
n=322 Participants
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
12 Month Non-cardiac Death Rate
|
0.6 percentage of participants
Interval 0.1 to 2.2
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 monthsPopulation: 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.
Outcome measures
| Measure |
OMEGA™ Monorail Coronary Stent System
n=322 Participants
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
12 Month All Death Rate
|
1.9 percentage of participants
Interval 0.7 to 4.0
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 monthsPopulation: 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.
Outcome measures
| Measure |
OMEGA™ Monorail Coronary Stent System
n=322 Participants
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
12 Month Cardiac Death or MI Rate
|
5.3 percentage of participants
Interval 3.1 to 8.3
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 monthsPopulation: 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.
Outcome measures
| Measure |
OMEGA™ Monorail Coronary Stent System
n=322 Participants
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
12 Month All Death or MI Rate
|
5.9 percentage of participants
Interval 3.6 to 9.1
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 monthsPopulation: 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.
Outcome measures
| Measure |
OMEGA™ Monorail Coronary Stent System
n=322 Participants
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
12 Month All Death/MI/TVR Rate
|
14.3 percentage of participants
Interval 10.7 to 18.6
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 monthsPopulation: 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.
Outcome measures
| Measure |
OMEGA™ Monorail Coronary Stent System
n=314 Participants
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
12 Month Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions)
|
0.6 percentage of participants
Interval 0.1 to 2.3
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayTechnical success: successful delivery and deployment of the study stent to the target vessel, without balloon rupture or embolization. Summarized per attempted study stent.
Outcome measures
| Measure |
OMEGA™ Monorail Coronary Stent System
n=337 Stents Attempted
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
Periprocedural Endpoints: Technical Success Rate
|
98.5 percentage of patients
Interval 96.6 to 99.5
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayClinical Procedural Success: lesion diameter stenosis \< 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death. Summarized per patient.
Outcome measures
| Measure |
OMEGA™ Monorail Coronary Stent System
n=328 Participants
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
Clinical Procedural Success Rate
|
95.4 percentage of patients
Interval 92.6 to 97.4
|
Adverse Events
OMEGA™ Monorail Coronary Stent System
Serious events: 108 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OMEGA™ Monorail Coronary Stent System
n=328 participants at risk
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Immune system disorders
Drug hypersensitivity
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Infections and infestations
Abdominal wall infection
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Infections and infestations
Bacterial sepsis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Infections and infestations
Diverticulitis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Infections and infestations
Gastroenteritis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Infections and infestations
Osteomyelitis
|
0.30%
1/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Infections and infestations
Pneumonia
|
0.61%
2/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.61%
2/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
4/328 • Number of events 4 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Angina pectoris
|
8.5%
28/328 • Number of events 29 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Angina unstable
|
4.9%
16/328 • Number of events 16 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
5/328 • Number of events 5 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Atrial flutter
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.91%
3/328 • Number of events 3 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Bradycardia
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Cardiac arrest
|
0.61%
2/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Cardiac asthma
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.91%
3/328 • Number of events 3 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Coronary artery disease
|
0.61%
2/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.2%
4/328 • Number of events 4 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.61%
2/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Myocardial infarction
|
0.61%
2/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.91%
3/328 • Number of events 3 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Pericarditis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.61%
2/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Anal polyp
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Colitis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Gastritis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Haematemesis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Melaena
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Nausea
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.91%
3/328 • Number of events 3 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
General disorders
Asthenia
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
General disorders
Chest discomfort
|
0.30%
1/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
General disorders
Impaired healing
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
General disorders
Non-cardiac chest pain
|
3.0%
10/328 • Number of events 10 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Injury, poisoning and procedural complications
Wound
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Investigations
Blood pressure abnormal
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Investigations
Cardiac enzymes increased
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Investigations
Cardiac stress test abnormal
|
0.61%
2/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.91%
3/328 • Number of events 3 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma stage IV
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign mediastinal neoplasm
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urethral cancer
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Nervous system disorders
Carotid artery disease
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Nervous system disorders
Cerebral infarction
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.61%
2/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Nervous system disorders
Dizziness
|
0.30%
1/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Nervous system disorders
Hemiplegia
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Nervous system disorders
Ischaemic stroke
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Nervous system disorders
Presyncope
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Nervous system disorders
Speech disorder
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Nervous system disorders
Syncope
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.61%
2/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Psychiatric disorders
Mental status changes
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Renal and urinary disorders
Haematuria
|
0.61%
2/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Renal and urinary disorders
Renal impairment
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.61%
2/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.61%
2/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Surgical and medical procedures
Cardiac pacemaker battery replacement
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Vascular disorders
Aortic aneurysm
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Vascular disorders
Arterial haemorrhage
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Vascular disorders
Haematoma
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Vascular disorders
Hypertension
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Vascular disorders
Hypertensive crisis
|
0.61%
2/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Vascular disorders
Intermittent claudication
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.30%
1/328 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Vascular disorders
Thrombosis
|
0.30%
1/328 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
Other adverse events
| Measure |
OMEGA™ Monorail Coronary Stent System
n=328 participants at risk
OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
4.6%
15/328 • Number of events 16 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Cardiac disorders
Coronary artery dissection
|
1.5%
5/328 • Number of events 5 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.2%
4/328 • Number of events 4 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
6/328 • Number of events 6 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
General disorders
Asthenia
|
2.4%
8/328 • Number of events 8 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
General disorders
Fatigue
|
1.2%
4/328 • Number of events 5 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
General disorders
Non-cardiac chest pain
|
4.0%
13/328 • Number of events 13 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
General disorders
Vessel puncture site haemorrhage
|
1.2%
4/328 • Number of events 4 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
8/328 • Number of events 8 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
4/328 • Number of events 4 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
4/328 • Number of events 4 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
7/328 • Number of events 9 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Nervous system disorders
Dizziness
|
1.5%
5/328 • Number of events 6 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Nervous system disorders
Headache
|
2.1%
7/328 • Number of events 7 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
12/328 • Number of events 13 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
5/328 • Number of events 5 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
|
Vascular disorders
Hypertension
|
2.1%
7/328 • Number of events 7 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months.
|
Additional Information
Peter Maurer, Director Clinical Trials
Peter Maurer, Director Clinical Trials
Phone: 508-683-6678
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and Investigator shall have the right to publish the results, provided that before publishing, Institution and Investigator shall submit copies of any proposed publication or presentation to Sponsor for review at least sixty (60) days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER