Trial Outcomes & Findings for Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions (NCT NCT01092416)
NCT ID: NCT01092416
Last Updated: 2023-07-18
Results Overview
OAS safety was measured by a composite of MACE at 30-days post procedure. MACE is composed of: * Cardiac death. * MI - defined as a CK-MB level \> 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave. * TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
443 participants
Primary outcome timeframe
30 days
Results posted on
2023-07-18
Participant Flow
The study received approval to enroll up to 429 subjects. Following the introduction of the Electric OAS, the enrollment was expanded to a maximum of 479 subjects, to enroll 100 subjects with the Electric OAS. A total of 443 subjects were enrolled in the study between May 25, 2010 and November 26, 2012 at 49 U.S. study sites.
A subject was considered enrolled when a signed informed consent was in place, all inclusion/no exclusion criteria were met, and the study guidewire had crossed the target lesion.
Participant milestones
| Measure |
ORBIT II Subjects
Subjects enrolled in ORBIT II study.
|
|---|---|
|
Enrollment
STARTED
|
443
|
|
Enrollment
COMPLETED
|
440
|
|
Enrollment
NOT COMPLETED
|
3
|
|
30-Day Follow-up
STARTED
|
440
|
|
30-Day Follow-up
COMPLETED
|
430
|
|
30-Day Follow-up
NOT COMPLETED
|
10
|
|
12-Month Follow-up
STARTED
|
438
|
|
12-Month Follow-up
COMPLETED
|
413
|
|
12-Month Follow-up
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
ORBIT II Subjects
Subjects enrolled in ORBIT II study.
|
|---|---|
|
Enrollment
Atherectomy device not inserted
|
3
|
|
30-Day Follow-up
Death
|
2
|
|
30-Day Follow-up
Missed 30-day follow-up
|
3
|
|
30-Day Follow-up
Data collected after close of 30D window
|
5
|
|
12-Month Follow-up
Death
|
16
|
|
12-Month Follow-up
Lost to Follow-up
|
4
|
|
12-Month Follow-up
Withdrawal by Subject
|
2
|
|
12-Month Follow-up
Missed 1-year follow-up
|
1
|
|
12-Month Follow-up
Data collected after close of 1Y window
|
2
|
Baseline Characteristics
Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions
Baseline characteristics by cohort
| Measure |
ORBIT II Subjects
n=443 Participants
Subjects enrolled in ORBIT II study.
|
|---|---|
|
Age, Continuous
|
71.4 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
286 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
390 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
25 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
15 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 30 days.
OAS safety was measured by a composite of MACE at 30-days post procedure. MACE is composed of: * Cardiac death. * MI - defined as a CK-MB level \> 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave. * TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure.
Outcome measures
| Measure |
ORBIT II Subjects
n=443 Participants
Subjects enrolled in ORBIT II study.
|
|---|---|
|
Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)
|
89.6 Percent probability of Freedom from MACE
Interval 86.7 to 92.5
|
PRIMARY outcome
Timeframe: Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 hours.Procedural success was defined as success in facilitating stent delivery with a residual stenosis of \<50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.
Outcome measures
| Measure |
ORBIT II Subjects
n=440 Participants
Subjects enrolled in ORBIT II study.
|
|---|---|
|
Primary Efficacy Endpoint: Procedural Success
|
88.9 Percentage of procedures
Interval 85.5 to 91.6
|
SECONDARY outcome
Timeframe: Baseline procedure, with a mean total procedure time of 52.5 minutes.Angiographic success was defined as success in facilitating stent delivery with \<50% residual stenosis and without severe angiographic complications.
Outcome measures
| Measure |
ORBIT II Subjects
n=443 Participants
Subjects enrolled in ORBIT II study.
|
|---|---|
|
Angiographic Success
|
91.4 Percentage of procedures
|
SECONDARY outcome
Timeframe: Baseline procedure, with a mean total procedure time of 52.5 minutes.Severe angiographic complications were defined as severe dissection (Type C to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
Outcome measures
| Measure |
ORBIT II Subjects
n=443 Participants
Subjects enrolled in ORBIT II study.
|
|---|---|
|
Severe Angiographic Complications
Type C, D, E, or F Dissection
|
15 Participants
|
|
Severe Angiographic Complications
Perforation
|
8 Participants
|
|
Severe Angiographic Complications
Persistent Slow Flow
|
4 Participants
|
|
Severe Angiographic Complications
Persistent No Reflow
|
0 Participants
|
|
Severe Angiographic Complications
Abrupt Closure
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 12 months.
The safety of the OAS was measured for the secondary safety endpoint consisting of a composite of freedom from MACE through 12 months of follow-up.
Outcome measures
| Measure |
ORBIT II Subjects
n=443 Participants
Subjects enrolled in ORBIT II study.
|
|---|---|
|
12-Month Freedom From Major Adverse Cardiac Events (MACE)
|
83.1 Percent probability of Freedom from MACE
Interval 79.6 to 86.7
|
Adverse Events
ORBIT II Subjects - 30 Day Results
Serious events: 109 serious events
Other events: 34 other events
Deaths: 0 deaths
ORBIT II Subjects - 1 Year Results
Serious events: 70 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ORBIT II Subjects - 30 Day Results
n=443 participants at risk
Serious Adverse Events reported out to 30 Days Post-Procedure for Subjects enrolled in ORBIT II study.
|
ORBIT II Subjects - 1 Year Results
n=438 participants at risk
Serious Adverse Events reported from 31 Days to 1 Year Post-Procedure for Subjects enrolled in ORBIT II study.
|
|---|---|---|
|
Cardiac disorders
Acute MI, Q-wave
|
0.90%
4/443 • Number of events 4
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Acute MI, non Q-wave
|
8.8%
39/443 • Number of events 39
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
1.1%
5/438 • Number of events 5
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Angina Pectoris
|
0.90%
4/443 • Number of events 4
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
5.3%
23/438 • Number of events 25
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Atrial fibrillation
|
0.45%
2/443 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
2.1%
9/438 • Number of events 9
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Atrioventricular block, II degree
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Cardiac/pericardial tamponade
|
0.90%
4/443 • Number of events 4
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Cardiogenic shock
|
0.45%
2/443 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Chest pain
|
0.45%
2/443 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.68%
3/438 • Number of events 3
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Endocarditis
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Non-target vessel revascularization
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.68%
3/438 • Number of events 4
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
PEA arrest
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Pericarditis
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Shock (Acute RV dysfunction and acute blood loss hypovolemic)
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.45%
2/443 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Ventricular tachycardia/ventricular fibrillation
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Surgical and medical procedures
Coronary artery embolism of air, plaque, thrombosis, or debris
|
0.68%
3/443 • Number of events 3
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Surgical and medical procedures
Slow flow or no reflow phenomena
|
0.68%
3/443 • Number of events 3
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Surgical and medical procedures
Thrombosis formation at site of treated lesion
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Vascular disorders
Hematoma at access site, requiring intervention
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Vascular disorders
Hemorrhage, major, requiring transfusion
|
0.68%
3/443 • Number of events 3
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Vascular disorders
Hypotension
|
0.45%
2/443 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Vascular disorders
Peripheral artery pseudoaneurysm
|
0.68%
3/443 • Number of events 3
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Vascular disorders
Peripheral artery/vascular disease
|
0.45%
2/443 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
2.1%
9/438 • Number of events 10
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Vascular disorders
Pulmonary embolism
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Nervous system disorders
Cerebrovascular accident (CVA)
|
0.68%
3/443 • Number of events 3
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Nervous system disorders
Sundowning/ICU "psychosis"
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
Anoxia due to aspiration
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
1.6%
7/438 • Number of events 14
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea/Shortness of breath
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 3
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.45%
2/443 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
1.4%
6/438 • Number of events 7
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
1.4%
6/438 • Number of events 6
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure, requiring intubation
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Gastrointestinal disorders
Colitis
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.91%
4/438 • Number of events 4
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Gastrointestinal disorders
Esophageal spasm
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.68%
3/443 • Number of events 3
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
1.1%
5/438 • Number of events 5
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Gastrointestinal disorders
Nausea and/or vomiting
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Renal and urinary disorders
Renal insufficiency
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Renal and urinary disorders
Urinary tract infection (UTI)
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
1.1%
5/438 • Number of events 5
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Cardiac death
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
2.7%
12/438 • Number of events 12
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
General disorders
Non-cardiac death
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.91%
4/438 • Number of events 4
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Bone fracture
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
1.4%
6/438 • Number of events 6
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
General disorders
Fever
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Infections and infestations
Infection at access site
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Infections and infestations
Left arm AV graft infection
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
General disorders
Lower extremity pain
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Surgical and medical procedures
Coronary vessel dissection present
|
5.2%
23/443 • Number of events 23
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Surgical and medical procedures
Coronary vessel perforation present
|
1.8%
8/443 • Number of events 8
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Surgical and medical procedures
Non-coronary right ventricle vessel perforation present
|
0.23%
1/443 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Acute congestive heart failure
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Arrhythmia, unspecified
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Chronic congestive heart failure, or exacerbation
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
1.8%
8/438 • Number of events 12
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Coronary artery restenosis
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
4.6%
20/438 • Number of events 22
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Heart flutter/nervous feeling in chest
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Pacemaker end of life
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Palpitation
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Vascular disorders
Carotid artery disease
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Vascular disorders
Hypertension
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Vascular disorders
Hematoma
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Nervous system disorders
Anxiety
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Vascular disorders
Cerebral artery aneurysm
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Nervous system disorders
Mental status changes
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Nervous system disorders
Panic attack
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Nervous system disorders
Stroke
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Nervous system disorders
Syncope
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
1.8%
8/438 • Number of events 9
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Nervous system disorders
Tinnitus
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Nervous system disorders
Transient ischemic attack (TIA)
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Infections and infestations
Flu
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
Multiple lymphadenopathy (on chest CT)
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Infections and infestations
Respiratory infection
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Hepatobiliary disorders
Bile duct leak
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Hepatobiliary disorders
Biloma
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Hepatobiliary disorders
Cirrhosis
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Gastrointestinal disorders
Complicated appendicitis (rupture)
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Hepatobiliary disorders
Complications post cholecystectomy
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Hepatobiliary disorders
Elevated liver function tests
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Hepatobiliary disorders
Gallstone
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Hepatobiliary disorders
Gangrenous gallbladder
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.91%
4/438 • Number of events 4
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Gastrointestinal disorders
Rectocoele repair
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
1.4%
6/438 • Number of events 6
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Renal and urinary disorders
Chronic renal failure, or exacerbation
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
1.1%
5/438 • Number of events 5
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
General disorders
Hyponatremia
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
General disorders
Supratherapeutic INR
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
General disorders
Death, unknown cause
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
2.1%
9/438 • Number of events 9
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Arthroplasty revision
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
General disorders
Back pain
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Eye disorders
Bilateral cataracts
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.68%
3/438 • Number of events 3
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Carpal tunnel syndrome
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Cellulitis
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.68%
3/438 • Number of events 3
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
General disorders
Chest pain, non-cardiac
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
General disorders
Epistaxis
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
General disorders
Fall/Loss of balance
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Infections and infestations
Infection at pacemaker site
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
General disorders
Metabolic acidosis
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloma
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
General disorders
Peripheral edema
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Surgical and medical procedures
Knee replacement
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Infections and infestations
Sepsis
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.46%
2/438 • Number of events 2
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Infections and infestations
Skin infection
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
Nervous system disorders
Spinal stenosis
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
General disorders
Trauma
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.68%
3/438 • Number of events 3
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
|
General disorders
Gangrene
|
0.00%
0/443
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.23%
1/438 • Number of events 1
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
Other adverse events
| Measure |
ORBIT II Subjects - 30 Day Results
n=443 participants at risk
Serious Adverse Events reported out to 30 Days Post-Procedure for Subjects enrolled in ORBIT II study.
|
ORBIT II Subjects - 1 Year Results
n=438 participants at risk
Serious Adverse Events reported from 31 Days to 1 Year Post-Procedure for Subjects enrolled in ORBIT II study.
|
|---|---|---|
|
Surgical and medical procedures
Angiographic Complications
|
7.7%
34/443 • Number of events 34
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
0.00%
0/438
Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any previously unpublished information provided to the Investigators by the Sponsor is confidential and will remain the sole property of the Sponsor. The Investigator agrees to use this information only in accomplishing this study not use it for other purposes without the Sponsor's written consent. An Investigator can generate additional publication ideas based on the trial data. The Sponsor reserves the right to review the manuscript prior to submission in order to verify accuracy of the data.
- Publication restrictions are in place
Restriction type: OTHER