Trial Outcomes & Findings for COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT (NCT NCT01925794)

NCT ID: NCT01925794

Last Updated: 2021-12-22

Results Overview

TVF defined as cardiac death, target vessel myocardial infarction (MI \[Q wave or non-Q wave, ARC definition\], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days post-procedure.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 296 participants
• Primary outcome timeframe: 270 days
• Results posted on: 2021-12-22

Participant Flow

There was a total of 296 patients enrolled on this study between August 2013 - February 2015. A total of 35 clinical sites contributed the 296 patients enrolled.

Participant milestones

Measure	COBRA PzF Stent COBRA PzF Coronary Stent System
30 Days STARTED	296
30 Days COMPLETED	296
30 Days NOT COMPLETED	0
180 Days STARTED	296
180 Days COMPLETED	292
180 Days NOT COMPLETED	4
270 Days STARTED	292
270 Days COMPLETED	287
270 Days NOT COMPLETED	5

Reasons for withdrawal

Measure	COBRA PzF Stent COBRA PzF Coronary Stent System
180 Days Death	2
180 Days Withdrawal by Subject	2
270 Days Death	2
270 Days Protocol Violation	3

Baseline Characteristics

COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT

Baseline characteristics by cohort

Measure	COBRA PzF Stent n=296 Participants COBRA PzF Coronary Stent System
Age, Continuous	66.46 years STANDARD_DEVIATION 10.29 • n=5 Participants
Sex: Female, Male Female	88 Participants n=5 Participants
Sex: Female, Male Male	208 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	180 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	100 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	12 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	17 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	206 Participants n=5 Participants
Race/Ethnicity, Customized Other	9 Participants n=5 Participants
Race/Ethnicity, Customized Not reported	52 Participants n=5 Participants
Region of Enrollment Latvia	27 Participants n=5 Participants
Region of Enrollment United States	166 Participants n=5 Participants
Region of Enrollment France	44 Participants n=5 Participants
Region of Enrollment Serbia	12 Participants n=5 Participants
Region of Enrollment Switzerland	4 Participants n=5 Participants
Region of Enrollment Germany	27 Participants n=5 Participants
Region of Enrollment Spain	16 Participants n=5 Participants
Body Mass Index (BMI)	29.46 kg/m^2 STANDARD_DEVIATION 5.32 • n=5 Participants

PRIMARY outcome

Timeframe: 270 days

TVF defined as cardiac death, target vessel myocardial infarction (MI [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days post-procedure.

Outcome measures

Measure	COBRA PzF Stent n=290 Participants COBRA PzF Coronary Stent System
Target Vessel Failure (TVF)	11.38 percentage of participants Interval 7.96 to 15.61

SECONDARY outcome

Timeframe: 30 days

Death from any cause

Outcome measures

Measure	COBRA PzF Stent n=296 Participants COBRA PzF Coronary Stent System
All Cause Mortality	1 Participants

SECONDARY outcome

Timeframe: 180 days

Population: The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Death from any cause

Outcome measures

Measure	COBRA PzF Stent n=294 Participants COBRA PzF Coronary Stent System
All Cause Mortality	5 Participants

SECONDARY outcome

Timeframe: 270 days

Population: The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Death from any cause

Outcome measures

Measure	COBRA PzF Stent n=294 Participants COBRA PzF Coronary Stent System
All Cause Mortality	6 Participants

SECONDARY outcome

Timeframe: 360 days

Population: The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Death from any cause

Outcome measures

Measure	COBRA PzF Stent n=291 Participants COBRA PzF Coronary Stent System
All Cause Mortality	7 Participants

SECONDARY outcome

Timeframe: 1800 days

Population: The denominator is comprised of all the patients who had enough follow-up for 1800-days analysis (at least 1770 days allowing for 30 days window) or patients who had an event within 1800 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Death from any cause

Outcome measures

Measure	COBRA PzF Stent n=283 Participants COBRA PzF Coronary Stent System
All Cause Mortality	34 Participants

SECONDARY outcome

Timeframe: 30 days

Death due to any of the following:

Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded

Outcome measures

Measure	COBRA PzF Stent n=296 Participants COBRA PzF Coronary Stent System
Cardiac Mortality	1 Participants

SECONDARY outcome

Timeframe: 180 days

Population: The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Death due to any of the following:

Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded

Outcome measures

Measure	COBRA PzF Stent n=292 Participants COBRA PzF Coronary Stent System
Cardiac Mortality	1 Participants

SECONDARY outcome

Timeframe: 270 days

Population: The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Death due to any of the following:

Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded

Outcome measures

Measure	COBRA PzF Stent n=289 Participants COBRA PzF Coronary Stent System
Cardiac Mortality	1 Participants

SECONDARY outcome

Timeframe: 360 days

Population: The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Death due to any of the following:

Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded

Outcome measures

Measure	COBRA PzF Stent n=286 Participants COBRA PzF Coronary Stent System
Cardiac Mortality	1 Participants

SECONDARY outcome

Timeframe: 1800 days

Population: KM analysis estimate for patients in the ITT population who had enough follow-up for 1800-days analysis (at least 1770 days allowing for 30 days window) or patients who had an event within 1800 days post-procedure and censoring those not reaching the endpoint or sufficient follow up.

Death due to any of the following:

Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded

Outcome measures

Measure	COBRA PzF Stent n=259 Participants COBRA PzF Coronary Stent System
Cardiac Mortality	3.99 percentage of participants Interval 1.68 to 6.29

SECONDARY outcome

Timeframe: 30 days

Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods

Outcome measures

Measure	COBRA PzF Stent n=296 Participants COBRA PzF Coronary Stent System
Major Adverse Cardiac Events (MACE)	19 Participants

SECONDARY outcome

Timeframe: 180 days

Population: The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods

Outcome measures

Measure	COBRA PzF Stent n=292 Participants COBRA PzF Coronary Stent System
Major Adverse Cardiac Events (MACE)	23 Participants

SECONDARY outcome

Timeframe: 270 days

Population: The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods

Outcome measures

Measure	COBRA PzF Stent n=289 Participants COBRA PzF Coronary Stent System
Major Adverse Cardiac Events (MACE)	29 Participants

SECONDARY outcome

Timeframe: 360 days

Population: The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods

Outcome measures

Measure	COBRA PzF Stent n=286 Participants COBRA PzF Coronary Stent System
Major Adverse Cardiac Events (MACE)	44 Participants

SECONDARY outcome

Timeframe: 1800 days

Population: KM analysis estimate for patients in the ITT population who had enough follow-up for 1800-days analysis (at least 1770 days allowing for 30 days window) or patients who had an event within 1800 days post-procedure and censoring those not reaching the endpoint or sufficient follow up.

Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods

Outcome measures

Measure	COBRA PzF Stent n=213 Participants COBRA PzF Coronary Stent System
Major Adverse Cardiac Events (MACE)	22 percentage of participants Interval 17.2 to 26.8

SECONDARY outcome

Timeframe: 30 days

Population: The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.

NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves (historical definition). ARC definition includes Troponin or CK-MB >3 x UNL

Outcome measures

Measure	COBRA PzF Stent n=295 Participants COBRA PzF Coronary Stent System
Myocardial Infarction (MI-ARC Definition) Q-wave MI	0 Participants
Myocardial Infarction (MI-ARC Definition) Non Q-wave MI	18 Participants
Myocardial Infarction (MI-ARC Definition) MI-ARC Definition	18 Participants

SECONDARY outcome

Timeframe: 180 days

Population: The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.

NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves

Outcome measures

Measure	COBRA PzF Stent n=291 Participants COBRA PzF Coronary Stent System
Myocardial Infarction (MI-ARC Definition) Q-wave MI	0 Participants
Myocardial Infarction (MI-ARC Definition) Non Q-wave MI	18 Participants
Myocardial Infarction (MI-ARC Definition) MI-ARC Definition	20 Participants

SECONDARY outcome

Timeframe: 270 days

Population: The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.

NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves

Outcome measures

Measure	COBRA PzF Stent n=288 Participants COBRA PzF Coronary Stent System
Myocardial Infarction (MI-ARC Definition) Q-wave MI	0 Participants
Myocardial Infarction (MI-ARC Definition) Non Q-wave MI	18 Participants
Myocardial Infarction (MI-ARC Definition) MI-ARC Definition	20 Participants

SECONDARY outcome

Timeframe: 360 days

Population: The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.

NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves

Outcome measures

Measure	COBRA PzF Stent n=285 Participants COBRA PzF Coronary Stent System
Myocardial Infarction (MI-ARC Definition) Q-wave MI	0 Participants
Myocardial Infarction (MI-ARC Definition) Non Q-wave MI	21 Participants
Myocardial Infarction (MI-ARC Definition) MI-ARC Definition	24 Participants

SECONDARY outcome

Timeframe: 1800 days

Population: KM analysis estimate for patients in the ITT population who had enough follow-up for 1800-days analysis (at least 1770 days allowing for 30 days window) or patients who had an event within 1800 days post-procedure and censoring those not reaching the endpoint or sufficient follow up.

Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.

NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves

Outcome measures

Measure	COBRA PzF Stent n=237 Participants COBRA PzF Coronary Stent System
Myocardial Infarction (MI-ARC Definition)	10.1 percentage of participants Interval 6.62 to 13.6

SECONDARY outcome

Timeframe: 30 days

Population: The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Composite Endpoint of Cardiac Death or MI (ARC definition)

Outcome measures

Measure	COBRA PzF Stent n=296 Participants COBRA PzF Coronary Stent System
Cardiac Death or MI (ARC Definition)	19 Participants

SECONDARY outcome

Timeframe: 180 days

Population: The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Composite Endpoint of Cardiac Death and MI (ARC definition)

Outcome measures

Measure	COBRA PzF Stent n=292 Participants COBRA PzF Coronary Stent System
Cardiac Death or MI (ARC Definition)	19 Participants

SECONDARY outcome

Timeframe: 270 days

Population: The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Composite Endpoint of Cardiac Death or MI (ARC definition)

Outcome measures

Measure	COBRA PzF Stent n=289 Participants COBRA PzF Coronary Stent System
Cardiac Death or MI (ARC Definition)	19 Participants

SECONDARY outcome

Timeframe: 360 days

Population: The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Composite Endpoint of Cardiac Death or MI (ARC definition)

Outcome measures

Measure	COBRA PzF Stent n=286 Participants COBRA PzF Coronary Stent System
Cardiac Death or MI (ARC Definition)	25 Participants

SECONDARY outcome

Timeframe: 30 days

Population: The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

Outcome measures

Measure	COBRA PzF Stent n=295 Participants COBRA PzF Coronary Stent System
Clinically Driven TLR	0 Participants

SECONDARY outcome

Timeframe: 180 days

Population: The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

Outcome measures

Measure	COBRA PzF Stent n=291 Participants COBRA PzF Coronary Stent System
Clinically Driven TLR	7 Participants

SECONDARY outcome

Timeframe: 270 days

Population: The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

Outcome measures

Measure	COBRA PzF Stent n=288 Participants COBRA PzF Coronary Stent System
Clinically Driven TLR	13 Participants

SECONDARY outcome

Timeframe: 360 days

Population: The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

Outcome measures

Measure	COBRA PzF Stent n=285 Participants COBRA PzF Coronary Stent System
Clinically Driven TLR (Clinical and Angiographic Cohorts)	27 Participants

SECONDARY outcome

Timeframe: 360 days

Population: The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

Outcome measures

Measure	COBRA PzF Stent n=170 Participants COBRA PzF Coronary Stent System
Clinically Driven TLR (Clinical Cohorts)	8 Participants

SECONDARY outcome

Timeframe: 1800 days

Population: KM analysis estimate for patients in the ITT population who had enough follow-up for 1800-days analysis (at least 1770 days allowing for 30 days window) or patients who had an event within 1800 days post-procedure and censoring those not reaching the endpoint or sufficient follow up.

Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

Outcome measures

Measure	COBRA PzF Stent n=228 Participants COBRA PzF Coronary Stent System
Clinically Driven TLR (Clinical and Angiographic Cohorts)	12 percentage of participants Interval 8.2 to 15.8

SECONDARY outcome

Timeframe: 1800 days

Population: KM analysis estimate for patients in the ITT population who had enough follow-up for 1800-days analysis (at least 1770 days allowing for 30 days window) or patients who had an event within 1800 days post-procedure and censoring those not reaching the endpoint or sufficient follow up.

Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

Outcome measures

Measure	COBRA PzF Stent n=139 Participants COBRA PzF Coronary Stent System
Clinically Driven TLR (Clinical Cohorts)	7.76 percentage of participants Interval 3.69 to 11.8

SECONDARY outcome

Timeframe: 30 days

Population: The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.

Outcome measures

Measure	COBRA PzF Stent n=295 Participants COBRA PzF Coronary Stent System
Clinically Driven TVR	1 Participants

SECONDARY outcome

Timeframe: 180 days

Population: The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.

Outcome measures

Measure	COBRA PzF Stent n=291 Participants COBRA PzF Coronary Stent System
Clinically Driven TVR	9 Participants

SECONDARY outcome

Timeframe: 270 days

Population: The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.

Outcome measures

Measure	COBRA PzF Stent n=289 Participants COBRA PzF Coronary Stent System
Clinically Driven TVR	17 Participants

SECONDARY outcome

Timeframe: 360 days

Population: The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.

Outcome measures

Measure	COBRA PzF Stent n=286 Participants COBRA PzF Coronary Stent System
Clinically Driven TVR	34 Participants

SECONDARY outcome

Timeframe: 30 days

TVF defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.

Outcome measures

Measure	COBRA PzF Stent n=296 Participants COBRA PzF Coronary Stent System
Target Vessel Failure (TVF)	20 Participants

SECONDARY outcome

Timeframe: 180 days

Population: The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

TVF defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.

Outcome measures

Measure	COBRA PzF Stent n=292 Participants COBRA PzF Coronary Stent System
Target Vessel Failure (TVF)	25 Participants

SECONDARY outcome

Timeframe: 360 days

Population: The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

TVF defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.

Outcome measures

Measure	COBRA PzF Stent n=287 Participants COBRA PzF Coronary Stent System
Target Vessel Failure (TVF)	50 Participants

SECONDARY outcome

Timeframe: 30 days

Population: The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.

Outcome measures

Measure	COBRA PzF Stent n=295 Participants COBRA PzF Coronary Stent System
Stroke (Ischemic and Hemorrhagic)	0 Participants

SECONDARY outcome

Timeframe: 180 days

Population: The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.

Outcome measures

Measure	COBRA PzF Stent n=292 Participants COBRA PzF Coronary Stent System
Stroke (Ischemic and Hemorrhagic)	1 Participants

SECONDARY outcome

Timeframe: 270 days

Population: The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.

Outcome measures

Measure	COBRA PzF Stent n=289 Participants COBRA PzF Coronary Stent System
Stroke (Ischemic and Hemorrhagic)	1 Participants

SECONDARY outcome

Timeframe: 30 days

Population: The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Attainment of <30% final residual stenosis of the target lesion using only the COBRA PzF Coronary Stent System

Outcome measures

Measure	COBRA PzF Stent n=291 Participants COBRA PzF Coronary Stent System
Device Success	291 Participants

SECONDARY outcome

Timeframe: 360 days

Population: The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.

Outcome measures

Measure	COBRA PzF Stent n=286 Participants COBRA PzF Coronary Stent System
Stroke (Ischemic and Hemorrhagic)	2 Participants

SECONDARY outcome

Timeframe: 30 days

Population: The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Attainment of <30% final residual stenosis of the target lesion using any percutaneous method

Outcome measures

Measure	COBRA PzF Stent n=292 Participants COBRA PzF Coronary Stent System
Lesion Success	254 Participants

SECONDARY outcome

Timeframe: 30 days

Population: The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Attainment of <30% final residual stenosis of the target lesion and no in-hospital MACE

Outcome measures

Measure	COBRA PzF Stent n=292 Participants COBRA PzF Coronary Stent System
Procedure Success	241 Participants

SECONDARY outcome

Timeframe: 30 days

Bleeding Complications: Procedure-related hemorrhagic event that requires a transfusion and/or surgical intervention Vascular Complications: May include pseudo aneurysm, arteriovenous fistula (AVF), peripheral ischemia/nerve injury, and vascular event requiring transfusion or surgical repair

Outcome measures

Measure	COBRA PzF Stent n=296 Participants COBRA PzF Coronary Stent System
Bleeding or Vascular Complications	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Early Stent Thrombosis (ARC Definition) 0-30 days post index procedure

Outcome measures

Measure	COBRA PzF Stent n=295 Participants COBRA PzF Coronary Stent System
Early Stent Thrombosis (ARC Definition)	0 Participants

SECONDARY outcome

Timeframe: 180 days

Population: The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Stent Thrombosis after 30 days and on or before 180 days

Outcome measures

Measure	COBRA PzF Stent n=291 Participants COBRA PzF Coronary Stent System
Late Stent Thrombosis	0 Participants

SECONDARY outcome

Timeframe: 270 days

Population: The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Stent Thrombosis after 30 days and on or before 270 days

Outcome measures

Measure	COBRA PzF Stent n=288 Participants COBRA PzF Coronary Stent System
Late Stent Thrombosis	0 Participants

SECONDARY outcome

Timeframe: 360 days

Population: The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.

Stent Thrombosis after 30 days and on or before 360 days

Outcome measures

Measure	COBRA PzF Stent n=285 Participants COBRA PzF Coronary Stent System
Late Stent Thrombosis	0 Participants

SECONDARY outcome

Timeframe: 1800 days

Population: KM analysis estimate for patients in the ITT population who had enough follow-up for 1800-days analysis (at least 1770 days allowing for 30 days window) or patients who had an event within 1800 days post-procedure and censoring those not reaching the endpoint or sufficient follow up.

Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.

Outcome measures

Measure	COBRA PzF Stent n=259 Participants COBRA PzF Coronary Stent System
Definite and Probable Stent Thrombosis	0 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 270 days

Population: Angiographic subset included 115 of the 296 enrolled. Therefore, only 115 participants analyzed.

Relative changes that occur in the percent diameter stenosis of the segment and are provided by the following relationship: % diameter stenosis= (1-[MLD/Reference diameter]) x 100

Outcome measures

Measure	COBRA PzF Stent n=115 Participants COBRA PzF Coronary Stent System
In-Segment Percent Diameter Stenosis In-Segment percent diameter stenosis (%DS)	38.34 percentage of vessel Standard Deviation 17.03
In-Segment Percent Diameter Stenosis In-Stent percent diameter stenosis (%DS)	36.89 percentage of vessel Standard Deviation 18.30

SECONDARY outcome

Timeframe: 270 days

Population: Angiographic subset included 115 of the 296 enrolled. Therefore, the overall number of participants analyzed for this outcome measure is 115.

• In-stent and in-Segment minimal lumen diameter obtained immediately after stent implantation and at angiographic assessment at 270 days.
• In-stent or in-segment late loss was defined as the difference between minimum lumen diameter (in-stent or in-segment) immediately after implantation and that obtained at angiographic follow-up at 270 days.

Outcome measures

Measure	COBRA PzF Stent n=115 Participants COBRA PzF Coronary Stent System
In-Stent and In-Segment MLD and Late Loss In-Stent Late Loss	0.83 mm Standard Deviation 0.48
In-Stent and In-Segment MLD and Late Loss In-segment late loss	0.52 mm Standard Deviation 0.49
In-Stent and In-Segment MLD and Late Loss In-stent minimum lumen diameter	1.78 mm Standard Deviation 0.63
In-Stent and In-Segment MLD and Late Loss In-segment minimum lumen diameter	1.72 mm Standard Deviation 0.60

SECONDARY outcome

Timeframe: 270 days

Population: Angiographic subset of patients

Angiographic subset included 115 of the 296 enrolled. Therefore, the overall number of participants analyzed for this outcome measure is 115.

Outcome measures

Measure	COBRA PzF Stent n=115 Participants COBRA PzF Coronary Stent System
Angiographic Endpoints In-segment binary restenosis	28.57 percentage of lesions
Angiographic Endpoints In-stent binary angiographic restenosis	25.64 percentage of lesions
Angiographic Endpoints Stent fracture	0.00 percentage of lesions

SECONDARY outcome

Timeframe: 270 days

Population: OCT subset included 57 of the 296 enrolled. Therefore, the overall number of participants analyzed for this outcome measure is 57.

in-stent neointimal thickness assessed by Optical Coherence Tomography

Outcome measures

Measure	COBRA PzF Stent n=57 Participants COBRA PzF Coronary Stent System
In-stent Neointimal Thickness (INT)	0.33 mm Standard Deviation 0.15

SECONDARY outcome

Timeframe: 270 days

Population: OCT subset included 57 of the 296 enrolled. Therefore, the overall number of participants analyzed for this outcome measure is 57.

This measure assess the average proportion of uncovered and or malapposed struts measured by Optical Coherence Tomography in participants

Outcome measures

Measure	COBRA PzF Stent n=57 Participants COBRA PzF Coronary Stent System
Percentage of Uncovered and/or Malapposed Struts	0.00 % of Uncovered and/or Malapposed Struts Standard Deviation 0.01

SECONDARY outcome

Timeframe: 270 days

Population: OCT subset included only 57 of the 296 participants enrolled. Therefore, only 57 participants analyzed.

Optical Coherence Tomography assessment of the lumen and stent area after the clinical follow up at 270 days

Outcome measures

Measure	COBRA PzF Stent n=57 Participants COBRA PzF Coronary Stent System
Lumen and Stent Area Measurements Lumen Area	5.52 mm^2 Standard Deviation 2.52
Lumen and Stent Area Measurements Stent Area	8.41 mm^2 Standard Deviation 2.69

SECONDARY outcome

Timeframe: 270 days

Population: OCT subset includes 57 of the 296 enrolled. Therefore, only 57 participants analyzed.

Optical Coherence Tomography assessment of the lumen and stent volume after the clinical follow up at 270 days

Outcome measures

Measure	COBRA PzF Stent n=57 Participants COBRA PzF Coronary Stent System
Lumen and Stent Volume Lumen volume	97.44 mm3 Standard Deviation 61.27
Lumen and Stent Volume Stent volume	149.06 mm3 Standard Deviation 75.99

Adverse Events

COBRA PzF Stent

Serious events: 87 serious events

Other events: 0 other events

Deaths: 34 deaths

Serious adverse events

Measure	COBRA PzF Stent n=296 participants at risk COBRA PzF Coronary Stent System
Cardiac disorders Acute Coronary Syndrome	1.4% 4/296 • Number of events 4 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Cardiac disorders Acute Myocardial Infarction	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Cardiac disorders Angina Pectoris	4.7% 14/296 • Number of events 15 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Cardiac disorders Angina Unstable	0.34% 1/296 • Number of events 2 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Cardiac disorders Atrial Fibrillation	2.7% 8/296 • Number of events 9 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Cardiac disorders Atrial Flutter	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Cardiac disorders Bradycardia	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Cardiac disorders Cardiac Failure Congestive	0.68% 2/296 • Number of events 2 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Cardiac disorders Cardiomyopathy	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Cardiac disorders Coronary Artery Disease	0.68% 2/296 • Number of events 2 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Cardiac disorders Coronary Artery Stenosis	2.7% 8/296 • Number of events 9 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Cardiac disorders Coronary Artery Thrombosis	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Cardiac disorders Myocardial Infarction	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Cardiac disorders Myocardial Ischaemia	0.68% 2/296 • Number of events 2 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Cardiac disorders Ventricular Fibrillation	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Ear and labyrinth disorders Vertigo	0.68% 2/296 • Number of events 2 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Gastrointestinal disorders Gastrooesophagitis	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Gastrointestinal disorders Ileus	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Gastrointestinal disorders Intestinal Haemorrhage	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Gastrointestinal disorders Intestinal Obstruction	0.34% 1/296 • Number of events 2 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
General disorders Asthenia	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
General disorders Chest Pain	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
General disorders Impaired Healing	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
General disorders Multi-Organ Failure	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
General disorders Non-Cardiac Chest Pain	2.0% 6/296 • Number of events 7 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Hepatobiliary disorders Hepatic Cirrhosis	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Infections and infestations Appendicitis Perforated	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Infections and infestations Necrotising Fasciitis	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Infections and infestations Nosocomial Infection	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Infections and infestations Oophoritis	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Infections and infestations Pneumonia	0.68% 2/296 • Number of events 2 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Infections and infestations Salpingitis	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Infections and infestations Tonsillitis	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Injury, poisoning and procedural complications Arterial Injury	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Injury, poisoning and procedural complications Arterial Restenosis	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Injury, poisoning and procedural complications Coronary Artery Restenosis	8.1% 24/296 • Number of events 25 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Injury, poisoning and procedural complications Post Pocedural Hematoma	0.68% 2/296 • Number of events 2 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Injury, poisoning and procedural complications Procedural Complication	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Injury, poisoning and procedural complications Vascular Access Complication	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Investigations Blood Creatinine Phosphokinase Increased	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Investigations Cardiac Enzymes Increased	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Investigations Electrocardiogram Change	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Musculoskeletal and connective tissue disorders Osteoarthritis	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Musculoskeletal and connective tissue disorders Pain in Extremity	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile Duct Cancer	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma Stage I	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural Mesothelioma	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Nervous system disorders Cerebrovascular Accident	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Nervous system disorders Dizziness	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Nervous system disorders Parkinsonian Gait	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Nervous system disorders Subarachnoid Haemorrhage	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Nervous system disorders Transient Ischemic Attack	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Nervous system disorders Vascular Dementia	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Renal and urinary disorders Calculus Ureteric	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Renal and urinary disorders Renal Failure Acute	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Renal and urinary disorders Renal Mass	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Skin and subcutaneous tissue disorders Urticaria	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Vascular disorders Arterial Stenosis	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Vascular disorders Haematoma	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Vascular disorders Hypotension	0.34% 1/296 • Number of events 1 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Vascular disorders Intermittent Claudication	0.34% 1/296 • Number of events 2 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Vascular disorders Peripheral Vascular Disorder	0.68% 2/296 • Number of events 2 • All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days

Other adverse events

Adverse event data not reported

Additional Information

Mark Barakat, MD

CeloNova BioSciences Inc.

Phone: (210) 489-4004

Email: mbarakat@celonova.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60