Trial Outcomes & Findings for Evaluation of Intracoronary Hyperoxemic Oxygen Therapy in Anterior Acute Myocardial Infarction Patients (IC-HOT) (NCT NCT02603835)
NCT ID: NCT02603835
Last Updated: 2023-09-15
Results Overview
Composite of death, reinfarction, clinically-driven target vessel revascularization, stent thrombosis (ARC definite or probable), new onset severe heart failure or readmission for heart failure, and TIMI major or minor bleeding. This outcome measure includes a hierarchical sum of the events, meaning if a subject experiences two event types they are only counted once in the overall NACE rate.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
30-Day
Results posted on
2023-09-15
Participant Flow
Participant milestones
| Measure |
SSO2 Therapy
Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
93
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Intracoronary Hyperoxemic Oxygen Therapy in Anterior Acute Myocardial Infarction Patients (IC-HOT)
Baseline characteristics by cohort
| Measure |
SSO2 Therapy
n=100 Participants
Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
SSO2 Therapy: Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
|
|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
91 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30-DayPopulation: All treated subjects
Composite of death, reinfarction, clinically-driven target vessel revascularization, stent thrombosis (ARC definite or probable), new onset severe heart failure or readmission for heart failure, and TIMI major or minor bleeding. This outcome measure includes a hierarchical sum of the events, meaning if a subject experiences two event types they are only counted once in the overall NACE rate.
Outcome measures
| Measure |
SSO2 Therapy
n=98 Participants
Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
|
|---|---|
|
Rate of Net Adverse Clinical Events (NACE)
Overall NACE
|
7 Participants
|
|
Rate of Net Adverse Clinical Events (NACE)
Death
|
0 Participants
|
|
Rate of Net Adverse Clinical Events (NACE)
Reinfarction/Spontaneous MI
|
1 Participants
|
|
Rate of Net Adverse Clinical Events (NACE)
Clinically Driven Target Vessel Revascularization
|
1 Participants
|
|
Rate of Net Adverse Clinical Events (NACE)
TIMI Major or Minor Bleeding
|
4 Participants
|
|
Rate of Net Adverse Clinical Events (NACE)
New Onset Severe Heart Failure
|
1 Participants
|
|
Rate of Net Adverse Clinical Events (NACE)
ARC Definite/Probable Stent Thrombosis
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: All treated subjects
Composite of cardiac death , target vessel MI, or clinically driven target Lesion revascularization
Outcome measures
| Measure |
SSO2 Therapy
n=98 Participants
Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
|
|---|---|
|
Rate of Target Lesion Failure
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All treated subjects population (n=100) minus subjects that discontinued the study prior to the 12-month follow-up (n=7).
Composite of death, reinfarction, clinically-driven target vessel revascularization, stent thrombosis (ARC definite or probable), new onset severe heart failure or readmission for heart failure, and TIMI major or minor bleeding. This outcome measure includes a hierarchical sum of the events, meaning if a subject experiences two or more event types they are only counted once in the overall NACE rate.
Outcome measures
| Measure |
SSO2 Therapy
n=93 Participants
Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
|
|---|---|
|
Rate of Net Adverse Clinical Events (NACE)
Overall NACE
|
10 Participants
|
|
Rate of Net Adverse Clinical Events (NACE)
Death
|
0 Participants
|
|
Rate of Net Adverse Clinical Events (NACE)
Reinfarction/Spontaneous MI
|
3 Participants
|
|
Rate of Net Adverse Clinical Events (NACE)
Clinically Driven Target Vessel Revascularization
|
3 Participants
|
|
Rate of Net Adverse Clinical Events (NACE)
TIMI Major or Minor Bleeding
|
5 Participants
|
|
Rate of Net Adverse Clinical Events (NACE)
New Onset Severe Heart Failure
|
1 Participants
|
|
Rate of Net Adverse Clinical Events (NACE)
ARC Definite/Probable Stent Thrombosis
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All Treated Subjects Population
Composite of cardiac death , target vessel MI, or clinically driven target Lesion revascularization
Outcome measures
| Measure |
SSO2 Therapy
n=100 Participants
Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
|
|---|---|
|
Target Lesion Failure
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: All treated subjects with analyzable cardiac MRI scans
Measurement of the % left ventricle (LV) necrosis
Outcome measures
| Measure |
SSO2 Therapy
n=85 Participants
Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
|
|---|---|
|
Median Infarct Size by Cardiac MRI
|
19.4 percentage of myocardial mass
Interval 8.8 to 28.9
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SECONDARY outcome
Timeframe: 4 days post-procedurePopulation: All treated subjects with analyzable cardiac MRI scans
Measurement of the % left ventricle (LV) showing microvascular obstruction
Outcome measures
| Measure |
SSO2 Therapy
n=78 Participants
Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
|
|---|---|
|
Microvascular Obstruction by Cardiac MRI
|
0.30 percentage of MVO of myocardial mass
Interval 0.0 to 2.4
|
Adverse Events
SSO2 Therapy
Serious events: 27 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SSO2 Therapy
n=100 participants at risk
Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
|
|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.0%
2/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Angina Pectoris
|
4.0%
4/100 • Number of events 4 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Atrial Flutter
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Cardiac Arrest
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Torsade de Pointes
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Ventricular Fibrillation
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Eye disorders
Blindness
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Gastrointestinal disorders
Haematemesis
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
General disorders
Non-Cardiac Chest Pain
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
General disorders
Pyrexia
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Infections and infestations
Diverticulitis
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Injury, poisoning and procedural complications
Vascular Injury
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Nervous system disorders
Encephalopathy
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Surgical and medical procedures
Percutaneous Coronary Intervention
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Surgical and medical procedures
Aortic Valve Replacement
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Surgical and medical procedures
Coronary Artery Bypass
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Vascular disorders
Haemorrhage
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Vascular disorders
Hypotension
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Vascular disorders
Aortic Stenosis
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
Other adverse events
| Measure |
SSO2 Therapy
n=100 participants at risk
Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
|
|---|---|
|
Cardiac disorders
Angina Pectoris
|
17.0%
17/100 • Number of events 18 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
9.0%
9/100 • Number of events 9 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Atrial Fibrillation
|
5.0%
5/100 • Number of events 5 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
General disorders
Fatigue
|
6.0%
6/100 • Number of events 6 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Dizziness
|
4.0%
4/100 • Number of events 4 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Ventricular Tachycardia
|
4.0%
4/100 • Number of events 4 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
3.0%
3/100 • Number of events 3 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Cardiac Ventricular Thrombosis
|
3.0%
3/100 • Number of events 3 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
3.0%
3/100 • Number of events 3 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Cardiac Arrest
|
2.0%
2/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Dyspnoea
|
2.0%
2/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Dyspnoea Exertional
|
2.0%
2/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Palpitations
|
2.0%
2/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Syncope
|
2.0%
2/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Arteriospasm Coronary
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Atrial Flutter
|
1.0%
1/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Bradycardia
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Chest Pain
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Pericarditis
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Presyncope
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Pulmonary Oedema
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Sinus Arrest
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Torsade de Pointes
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Ventricular Fibrillation
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Cardiac disorders
Ventricular Hypokinesia
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Ear and labyrinth disorders
Ear Pain
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Eye disorders
Blindness
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Eye disorders
Vision Blurred
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
4/100 • Number of events 4 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
2/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
2/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Gastrointestinal disorders
Colitis
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Gastrointestinal disorders
Consitpation
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Gastrointestinal disorders
Flatulence
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Gastrointestinal disorders
Haematemesis
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
General disorders
Non-Cardiac Chest Pain
|
3.0%
3/100 • Number of events 3 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
General disorders
Malaise
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
General disorders
Pyrexia
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
General disorders
Vascular Stent Thrombosis
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Infections and infestations
Pneumonia
|
2.0%
2/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Infections and infestations
Acute Sinusitis
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Infections and infestations
Cellulitis
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Infections and infestations
Diverticulitis
|
1.0%
1/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Infections and infestations
Urinary Tract Infection Fungal
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Injury, poisoning and procedural complications
Laceration
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Injury, poisoning and procedural complications
Periorbital Haematoma
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Injury, poisoning and procedural complications
Vascular Injury
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Investigations
Blood Electrolytes Abnormal
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Investigations
Ejection Fraction Decreased
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Metabolism and nutrition disorders
Gout
|
2.0%
2/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.0%
2/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.0%
2/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.0%
1/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
2.0%
2/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Plantar Fasciitis
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Nervous system disorders
Headache
|
2.0%
2/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Nervous system disorders
Encephalopathy
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Nervous system disorders
Lethargy
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Nervous system disorders
Migraine
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Product Issues
Device Operational Issue
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Psychiatric disorders
Depression
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Psychiatric disorders
Mental Status Changes
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Renal and urinary disorders
Haematuria
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
3/100 • Number of events 3 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
2/100 • Number of events 3 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous Emphysema
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Surgical and medical procedures
Aortic Valve Replacement
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Surgical and medical procedures
Coronary Artery Bypass
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Surgical and medical procedures
Mitral Valve Replacement
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Surgical and medical procedures
Percutaneous Coronary Intervention
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Vascular disorders
Haematoma
|
6.0%
6/100 • Number of events 6 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Vascular disorders
Hypotension
|
6.0%
6/100 • Number of events 6 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Vascular disorders
Haemorrhage
|
5.0%
5/100 • Number of events 6 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Vascular disorders
Hypertension
|
2.0%
2/100 • Number of events 2 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Vascular disorders
Aortic Stenosis
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
1/100 • Number of events 1 • 1 year
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Per the clinical trial agreement executed between the Sponsor and one or more Primary Investigators: "The PRIMARY INVESTIGATOR and/or other INSTITUTION clinical research personnel cannot publicly report the single-center results until an all-inclusive multicenter manuscript is in press or one (1) year following the completion of this STUDY."
- Publication restrictions are in place
Restriction type: OTHER