Trial Outcomes & Findings for Medtronic Resolute Onyx 2.0 mm Clinical Study (NCT NCT02412501)
NCT ID: NCT02412501
Last Updated: 2019-07-02
Results Overview
Target Lesion Failure at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (Q wave or non-Q wave) or Target Lesion Revascularization by percutaneous or surgical methods.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
12 Months
Results posted on
2019-07-02
Participant Flow
Participant milestones
| Measure |
Device
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System \>
\> Resolute Onyx Stent - 2.0 mm
|
|---|---|
|
Overall Study
STARTED
|
101
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Medtronic Resolute Onyx 2.0 mm Clinical Study
Baseline characteristics by cohort
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System \>
\> Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
70 Participants
n=5 Participants
|
|
Age, Continuous
|
67.3 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
82 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
15 participants
n=5 Participants
|
|
BMI
|
29.0 kg/m2
STANDARD_DEVIATION 6.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsTarget Lesion Failure at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (Q wave or non-Q wave) or Target Lesion Revascularization by percutaneous or surgical methods.
Outcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With Target Lesion Failure at 12 Months Post-Procedure
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsOutcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With Cardiac Death at 12 Months Post Procedure
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsTVMI defined as Q Wave or non-Q Wave MI
Outcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure
|
3 Participants
|
SECONDARY outcome
Timeframe: 12MonthsOutcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 MonthsOutcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsOutcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsOutcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 MonthsOutcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With Cardiac Death at 24 Months Post Procedure
|
2 Participants
|
SECONDARY outcome
Timeframe: 24 MonthsTVMI defined as Q Wave or non-Q Wave MI
Outcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 MonthsOutcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure
|
14 Participants
|
SECONDARY outcome
Timeframe: 24 MonthsOutcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure
|
14 Participants
|
SECONDARY outcome
Timeframe: 24 MonthsOutcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure
|
0 Participants
|
SECONDARY outcome
Timeframe: 36 MonthsOutcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure
|
14 Participants
|
SECONDARY outcome
Timeframe: 36 MonthsOutcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With Cardiac Death at 36 Months Post Procedure
|
2 Participants
|
SECONDARY outcome
Timeframe: 36 MonthsTVMI defined as Q Wave or non-Q Wave MI
Outcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure
|
4 Participants
|
SECONDARY outcome
Timeframe: 36 MonthsOutcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure
|
15 Participants
|
SECONDARY outcome
Timeframe: 36 MonthsOutcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure
|
15 Participants
|
SECONDARY outcome
Timeframe: 36 MonthsOutcome measures
| Measure |
Device
n=101 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent \>
\> Resolute Onyx Stent - 2.0 mm: Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
|
|---|---|
|
Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure
|
0 Participants
|
Adverse Events
1. Onyx 2.0mm
Serious events: 63 serious events
Other events: 43 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
1. Onyx 2.0mm
n=101 participants at risk
Medtronic Onyx 2.0mm
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
3.0%
3/101 • Number of events 3 • 36 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Cardiac disorders
Acute Left Ventricular Failure
|
3.0%
3/101 • Number of events 3 • 36 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Cardiac disorders
Angina Pectoris
|
3.0%
3/101 • Number of events 3 • 36 months
|
|
Cardiac disorders
Angina Unstable
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Cardiac disorders
Anginal Equivalent
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Cardiac disorders
Arrhythmia
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Cardiac disorders
Atrial Fibrillation
|
2.0%
2/101 • Number of events 3 • 36 months
|
|
Cardiac disorders
Atrial Flutter
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Cardiac disorders
Atrial Tachycardia
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Cardiac disorders
Cardiac Aneurysm
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Cardiac disorders
Cardiomyopathy
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Cardiac disorders
Coronary Artery Disease
|
10.9%
11/101 • Number of events 12 • 36 months
|
|
Cardiac disorders
Coronary Artery Stenosis
|
5.0%
5/101 • Number of events 7 • 36 months
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Cardiac disorders
Sinus Bradycardia
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Eye disorders
Cataract
|
0.99%
1/101 • Number of events 2 • 36 months
|
|
Eye disorders
Eye Swelling
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Diverticulum Intestinal Haemorrhagic
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Gastric Perforation
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Gastric Ulcer
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Inguinal Hernia
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Nausea
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
General disorders
Chest Discomfort
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
General disorders
Chest Pain
|
5.0%
5/101 • Number of events 6 • 36 months
|
|
General disorders
Chills
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
General disorders
Non-Cardiac Chest Pain
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
General disorders
Pyrexia
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
General disorders
Vascular Stent Stenosis
|
5.9%
6/101 • Number of events 7 • 36 months
|
|
Hepatobiliary disorders
Biliary Colic
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Infections and infestations
Bronchitis Bacterial
|
2.0%
2/101 • Number of events 3 • 36 months
|
|
Infections and infestations
Clostridium Difficile Colitis
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Infections and infestations
Colon Gangrene
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Infections and infestations
Diverticulitis
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Infections and infestations
Extradural Abscess
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Infections and infestations
Influenza
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Infections and infestations
Osteomyelitis
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Infections and infestations
Pneumonia
|
4.0%
4/101 • Number of events 8 • 36 months
|
|
Infections and infestations
Pneumonia Mycoplasmal
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Infections and infestations
Post Procedural Infection
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Infections and infestations
Sepsis
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Infections and infestations
Sepsis Syndrome
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Infections and infestations
Urinary Tract Infection
|
3.0%
3/101 • Number of events 6 • 36 months
|
|
Injury, poisoning and procedural complications
Cartilage Injury
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Osteoradionecrosis
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Plaque Shift
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.99%
1/101 • Number of events 2 • 36 months
|
|
Injury, poisoning and procedural complications
Transplant Failure
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Traumatic Haemorrhage
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Traumatic Renal Injury
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Investigations
Haematocrit Decreased
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Investigations
Haemoglobin Decreased
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Investigations
Troponin Increased
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral Neoplasm
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal Cancer Recurrent
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma Of The Oral Cavity
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Nervous system disorders
Aphasia
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Nervous system disorders
Carotid Artery Stenosis
|
3.0%
3/101 • Number of events 3 • 36 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
3.0%
3/101 • Number of events 3 • 36 months
|
|
Nervous system disorders
Dizziness
|
0.99%
1/101 • Number of events 2 • 36 months
|
|
Nervous system disorders
Encephalopathy
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Nervous system disorders
Ischaemic Stroke
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Nervous system disorders
Presyncope
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Nervous system disorders
Radiculopathy
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Nervous system disorders
Sciatica
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Nervous system disorders
Seizure
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Nervous system disorders
Syncope
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Product Issues
Device Occlusion
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Psychiatric disorders
Agitation
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Renal and urinary disorders
Bladder Outlet Obstruction
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Renal and urinary disorders
Haematuria
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Renal and urinary disorders
Nephropathy Toxic
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Renal and urinary disorders
Renal Cortical Necrosis
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
2.0%
2/101 • Number of events 6 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
4.0%
4/101 • Number of events 10 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Acidosis
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.0%
4/101 • Number of events 5 • 36 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Vascular disorders
Aortic Aneurysm
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Vascular disorders
Hypertensive Crisis
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Vascular disorders
Hypertensive Emergency
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Vascular disorders
Hypotension
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Vascular disorders
Intermittent Claudication
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Vascular disorders
Orthostatic Hypotension
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
2.0%
2/101 • Number of events 2 • 36 months
|
|
Vascular disorders
Peripheral Artery Aneurysm
|
0.99%
1/101 • Number of events 1 • 36 months
|
|
Vascular disorders
Peripheral Vascular Disorder
|
2.0%
2/101 • Number of events 2 • 36 months
|
Other adverse events
| Measure |
1. Onyx 2.0mm
n=101 participants at risk
Medtronic Onyx 2.0mm
|
|---|---|
|
General disorders
Chest Pain
|
14.9%
15/101 • Number of events 18 • 36 months
|
|
General disorders
Non-Cardiac Chest Pain
|
5.9%
6/101 • Number of events 7 • 36 months
|
|
Investigations
Myocardial Necrosis Marker Increased
|
6.9%
7/101 • Number of events 7 • 36 months
|
|
Investigations
Troponin I Increased
|
5.9%
6/101 • Number of events 6 • 36 months
|
|
Investigations
Troponin Increased
|
8.9%
9/101 • Number of events 9 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.9%
8/101 • Number of events 8 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.8%
17/101 • Number of events 17 • 36 months
|
|
Vascular disorders
Hypertension
|
5.9%
6/101 • Number of events 7 • 36 months
|
Additional Information
Beth Moe, Clinical Study Manager
Medtronic Coronary/Structural Heart
Phone: 763-526-1184
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER