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

Sponsor

CeloNova BioSciences, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01925794

Collaborator

(none)

296

Enrollment

Locations

Arm

78.4

Duration (Months)

8.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, multi-center, non-randomized, single arm clinical trial that will be conducted at up to 40 sites in the United States and Outside United States (OUS). This study will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion contained within a native coronary artery with reference vessel diameter between 2.5 mm and 4.0 mm and lesion length ≤ 24 mm that is amenable to percutaneous coronary intervention (PCI) and stent deployment. All patients will be followed at 30 days, 6 months, 9 months, 1 year and annually for 5 years post index stenting procedure.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: COBRA PzF	N/A

Detailed Description

The main objective of this study is to evaluate the safety and effectiveness of the COBRA PzF™ Coronary Stent System in the treatment of de novo lesions in native coronary arteries. The primary endpoint will be the incidence of target vessel failure (TVF, see definition below) within 270 days of treatment with the COBRA PzFTM Coronary Stent System. This rate will be compared to a performance goal derived using a meta-analysis from published historical data of the standard-of-care therapy, coronary stenting with bare metal stents.

PRIMARY STUDY HYPOTHESIS The CeloNova COBRA PzFTM Study will have a primary endpoint (TVF) rate less than 19.62% and by that will meet the performance goal for bare metal stents, per the results of the historical control group combined with relevant data for EXPRESS™, Driver™, Presillion/Presillion plus™ and NIRFLEX™ stents.

SECONDARY STUDY HYPOTHESIS The powered secondary endpoint for this trial is that the CeloNova COBRA PzFTM Study will have a 9-month in-stent late loss (LL) that meets or is lower than the performance goal of 1.1 mm.

NUMBER OF PATIENTS 296 patients will be enrolled to account for loss to follow-up, which is estimated to be approximately 5% (resulting in 281 evaluable patients), at up to 40 sites in United States and OUS. At least 40% of subjects will be enrolled in the United States.

PRIMARY ENDPOINT Target vessel failure (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.

SECONDARY ENDPOINTS

All Death at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
Cardiac Death at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
Major Adverse Cardiac Events (MACE), defined as cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
MI at 30, 180 and 270, 360, 720, 1080, 1440, and 1800 days CeloNova Biosciences, Inc. Confidential CeloNova COBRA PzF™ Study Protocol # COBRA 2012-01 6 07 May 14
Clinically driven TLR at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
Stroke (ischemic and hemorrhagic) at 30, 180, 270 and 360 days
Clinically driven TVR at 30, 180, 270 and 360 days
Composite Endpoint of Cardiac Death and MI at 30, 180, 270, and 360 days
TVF at 30, 180, and 360 days
Acute Success Rates
Device Success: Attainment of < 30% final residual stenosis of the target lesion using only the COBRA PzFTM Coronary Stent System.
Lesion Success: Attainment of < 30% final residual stenosis of the target lesion using any percutaneous method.
Procedure Success: Attainment of < 30% final residual stenosis of the target lesion and no in-hospital MACE.
Bleeding or Vascular Complications at hospital discharge
Early Stent Thrombosis (ARC defined) at 30 days
Late Stent Thrombosis at 180, 270, and 360 days
Angiographic Endpoints (on first 90 evaluable patients) at 270 days (after clinical assessment)
In-stent late loss (Secondary Endpoint hypothesis)
In-segment percent diameter stenosis (%DS) (within the 5 mm margins proximal and distal to stent)
In-stent percent diameter stenosis (%DS)
In-segment late loss
In-segment binary restenosis (stenosis of > 50% of the reference vessel diameter)
In-stent binary restenosis
In-stent minimum lumen diameter (MLD)
In-segment MLD
Longitudinal stent deformation
Stent fracture
Optical Coherence Tomography Endpoints (on 45 subjects) at 270 days (after clinical assessment)
in-stent neointimal thickness (NT)
Lumen area
Lumen volume
Stent area
Stent volume
Proportion of uncovered and/or malopposed struts
Stent fracture

Study Design

Study Type:

Interventional

Actual Enrollment :

296 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

COBRA PZF™ Coronary Stent System in Native Coronary Arteries for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term Dual Anti-Platelet Therapy. The PzF Shield Trial

Study Start Date :

Aug 21, 2013

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Mar 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: COBRA PzF Stent Single Arm study	Device: COBRA PzF

Arm

Intervention/Treatment

Experimental: COBRA PzF Stent

Single Arm study

Device: COBRA PzF

Outcome Measures

Primary Outcome Measures

Target Vessel Failure (TVF) [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.

Secondary Outcome Measures

All Cause Mortality [30 days]
Death from any cause
All Cause Mortality [180 days]
Death from any cause
All Cause Mortality [270 days]
Death from any cause
All Cause Mortality [360 days]
Death from any cause
All Cause Mortality [1800 days]
Death from any cause
Cardiac Mortality [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
Cardiac Mortality [180 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
Cardiac Mortality [270 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
Cardiac Mortality [360 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
Cardiac Mortality [1800 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
Major Adverse Cardiac Events (MACE) [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
Major Adverse Cardiac Events (MACE) [180 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
Major Adverse Cardiac Events (MACE) [270 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
Major Adverse Cardiac Events (MACE) [360 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
Major Adverse Cardiac Events (MACE) [1800 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
Myocardial Infarction (MI-ARC Definition) [30 days]
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
Myocardial Infarction (MI-ARC Definition) [180 days]
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
Myocardial Infarction (MI-ARC Definition) [270 days]
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
Myocardial Infarction (MI-ARC Definition) [360 days]
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
Myocardial Infarction (MI-ARC Definition) [1800 days]
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
Cardiac Death or MI (ARC Definition) [30 days]
Composite Endpoint of Cardiac Death or MI (ARC definition)
Cardiac Death or MI (ARC Definition) [180 days]
Composite Endpoint of Cardiac Death and MI (ARC definition)
Cardiac Death or MI (ARC Definition) [270 days]
Composite Endpoint of Cardiac Death or MI (ARC definition)
Cardiac Death or MI (ARC Definition) [360 days]
Composite Endpoint of Cardiac Death or MI (ARC definition)
Clinically Driven TLR [30 days]
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.
Clinically Driven TLR [180 days]
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.
Clinically Driven TLR [270 days]
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.
Clinically Driven TLR (Clinical and Angiographic Cohorts) [360 days]
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.
Clinically Driven TLR (Clinical Cohorts) [360 days]
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.
Clinically Driven TLR (Clinical and Angiographic Cohorts) [1800 days]
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.
Clinically Driven TLR (Clinical Cohorts) [1800 days]
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.
Clinically Driven TVR [30 days]
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.
Clinically Driven TVR [180 days]
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.
Clinically Driven TVR [270 days]
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.
Clinically Driven TVR [360 days]
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.
Target Vessel Failure (TVF) [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.
Target Vessel Failure (TVF) [180 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.
Target Vessel Failure (TVF) [360 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.
Stroke (Ischemic and Hemorrhagic) [30 days]
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.
Stroke (Ischemic and Hemorrhagic) [180 days]
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.
Stroke (Ischemic and Hemorrhagic) [270 days]
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.
Device Success [30 days]
Attainment of <30% final residual stenosis of the target lesion using only the COBRA PzF Coronary Stent System
Stroke (Ischemic and Hemorrhagic) [360 days]
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.
Lesion Success [30 days]
Attainment of <30% final residual stenosis of the target lesion using any percutaneous method
Procedure Success [30 days]
Attainment of <30% final residual stenosis of the target lesion and no in-hospital MACE
Bleeding or Vascular Complications [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
Early Stent Thrombosis (ARC Definition) [30 days]
Early Stent Thrombosis (ARC Definition) 0-30 days post index procedure
Late Stent Thrombosis [180 days]
Stent Thrombosis after 30 days and on or before 180 days
Late Stent Thrombosis [270 days]
Stent Thrombosis after 30 days and on or before 270 days
Late Stent Thrombosis [360 days]
Stent Thrombosis after 30 days and on or before 360 days
Definite and Probable Stent Thrombosis [1800 days]
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.
In-Segment Percent Diameter Stenosis [270 days]
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
In-Stent and In-Segment MLD and Late Loss [270 days]
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.
Angiographic Endpoints [270 days]
Angiographic subset included 115 of the 296 enrolled. Therefore, the overall number of participants analyzed for this outcome measure is 115.
In-stent Neointimal Thickness (INT) [270 days]
in-stent neointimal thickness assessed by Optical Coherence Tomography
Percentage of Uncovered and/or Malapposed Struts [270 days]
This measure assess the average proportion of uncovered and or malapposed struts measured by Optical Coherence Tomography in participants
Lumen and Stent Area Measurements [270 days]
Optical Coherence Tomography assessment of the lumen and stent area after the clinical follow up at 270 days
Lumen and Stent Volume [270 days]
Optical Coherence Tomography assessment of the lumen and stent volume after the clinical follow up at 270 days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

General Inclusion Criteria:

Patient >/= to 18 years old.
Eligible for percutaneous coronary intervention (PCI).
Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
Acceptable candidate for coronary artery bypass graft (CABG) surgery.
Stable angina pectoris (Canadian Cardiovascular Society (CCS) 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g., ETT, SPECT, Stress echocardiography or Cardiac CT).
Male or non-pregnant female patient (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).

Angiographic Inclusion Criteria

Patient indicated for elective stenting of a single stenotic lesion in a native coronary artery.
Reference vessel >/= 2.5 mm and </= 4.0 mm in diameter by visual estimate.
Target lesion </= 24 mm in length by visual estimate (the intention should be to cover the whole lesion with one stent of adequate length).
Protected left main lesion with >50% stenosis.
Target lesion stenosis >/= 70% and < 100% by visual estimate.
Target lesion stenosis <70% who meet physiological criteria for revascularization (i.e. positive FFR).

General Exclusion Criteria:

Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
Previously enrolled in another stent trial within the prior 2 years.
ANY planned elective surgery or percutaneous intervention within the subsequent 3 months.
A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
The patient requires staged procedure of either the target or any non-target vessel within 9 months post-procedure.
The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
Previous drug eluting stent (DES) deployment anywhere in the target vessel.
Any previous stent placement within 15 mm (proximal or distal) of the target lesion.
Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
Concurrent medical condition with a life expectancy of less than 12 months.
Documented left ventricular ejection fraction (LVEF) < 30% within 12 months prior to enrollment.
Patients with diagnosis of MI within 72 hours (i.e. CK-MB must be returned to normal prior to enrollment) or suspected acute MI at time of enrollment
Previous brachytherapy in the target vessel.
History of cerebrovascular accident or transient ischemic attack in the last 6 months.
Leukopenia (leukocytes < 3.5 x 10(9) / liter).
Neutropenia (Absolute Neutrophil Count < 1000/mm3) </= 3 days prior to enrollment.
Thrombocytopenia (platelets < 100,000/mm3) pre-procedure.
Active peptic ulcer or active GI bleeding.
History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated.
Serum creatinine level > 2.0 mg/dl within 7 days prior to index procedure.
Patients unable to tolerate dual anti-platelets therapy (DAPT) for one month post procedure.

Angiographic Exclusion Criteria

Unprotected left main coronary artery disease (obstruction greater than 50% in the left main coronary artery that is not protected by at least one non-obstructed bypass graft to the LAD or Circumflex artery or a branch thereof).
Target vessel with any lesions with greater than 50% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line QCA.
Target lesion (or vessel) exhibiting an intraluminal thrombus (occupying > 50% of the true lumen diameter) at any time.
Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
Target lesion with side branches > 2.0mm in diameter.
Target vessel is excessively tortuous (two bends > 90˚ to reach the target lesion).
Target lesion is severely calcified.
TIMI flow 0 or 1
Target lesion is in a bypass graft

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bakersfield Memorial Hospital	Bakersfield	California	United States	93303
2	Mt Sinai Medical Center	Miami Beach	Florida	United States	33140
3	Emory University Hospital	Atlanta	Georgia	United States	30322
4	Heart Center of Indiana	Indianapolis	Indiana	United States	46290
5	Louisiana Heart Hospital	Lacombe	Louisiana	United States	70445
6	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
7	Deborah Heart & Lung Center	Browns Mills	New Jersey	United States	08015
8	St Joseph's Hospital	Liverpool	New York	United States	13088
9	Lenox Hill Hospital	New York	New York	United States	10075
10	Mount Sinai Hospital	New York	New York	United States	11029
11	Oklahoma Foundation for Cardiovascular Research	Oklahoma City	Oklahoma	United States	73120
12	Southern Oregon Cardiology	Medford	Oregon	United States	97504
13	York General Hospital	York	Pennsylvania	United States	17403
14	Cardiology Consultants of Texas	Dallas	Texas	United States	75226
15	Plaza Medical Center	Fort Worth	Texas	United States	76104
16	Houston Methodist Hospital	Houston	Texas	United States	77030
17	Texas Cardiac Center	Lubbock	Texas	United States	79410
18	The Heart Hospital Baylor Plano	Plano	Texas	United States	75093
19	San Antonio Endovascular & Heart Institute	San Antonio	Texas	United States	78258
20	Tyler Cardiovascular Consultants	Tyler	Texas	United States	75701
21	Virginia Cardiovascular Specialists	Richmond	Virginia	United States	23229
22	Aspirus Heart & Vascular Institute	Wausau	Wisconsin	United States	54401
23	Clinique Axium	Aix en Provence		France	13097
24	Hopital Henri Duffaut	Avignon		France	84902
25	Albert Schweitzer Hospital	Colmar		France	68000
26	Clinique du Diaconat	Mulhouse		France	68100
27	Centre Hospitalier de Pau	Pau		France	64046
28	Clinique St. Hilaire	Rouen		France	76600
29	Sankt Kathatinen Hospital	Frankfurt		Germany	60389
30	Kardiologische Praxis und Praxisklinik	Munchen		Germany	81379
31	Paul Stradins Clinical University Hospital	Riga		Latvia	2166
32	Clinical Center of Serbia	Belgrade		Serbia	11000
33	Hospital de la Santa Creu	Barcelona		Spain	08025
34	Hospital Clinico San Carlos	Madrid		Spain	28040
35	Kantonsspital St. Gallen	St. Gallen		Switzerland	CH-9007

Sponsors and Collaborators

CeloNova BioSciences, Inc.

Investigators

Principal Investigator: Donald Cutlip, MD, Executive Director, Clinical Investigation, Harvard Clinical Research Institute
Principal Investigator: Sigmund Sliber, MD, Professor of Medicine at The University of Munich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CeloNova BioSciences, Inc.

ClinicalTrials.gov Identifier:

NCT01925794

Other Study ID Numbers:

COBRA 2012-01

First Posted:

Aug 20, 2013

Last Update Posted:

Dec 22, 2021

Last Verified:

Mar 1, 2021

Keywords provided by CeloNova BioSciences, Inc.

Stent, Coronary Arteries for Early healing

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent System
Period Title: 30 Days
STARTED	296
COMPLETED	296
NOT COMPLETED	0
Period Title: 30 Days
STARTED	296
COMPLETED	292
NOT COMPLETED	4
Period Title: 30 Days
STARTED	292
COMPLETED	287
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent System
Overall Participants	296
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.46 (10.29)
Sex: Female, Male (Count of Participants)
Female	88 29.7%
Male	208 70.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	16 5.4%
Not Hispanic or Latino	180 60.8%
Unknown or Not Reported	100 33.8%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaskan	0 0%
Asian	12 4.1%
Black or African American	17 5.7%
Native Hawaiian or Pacific Islander	0 0%
White or Caucasian	206 69.6%
Other	9 3%
Not reported	52 17.6%
Region of Enrollment (Count of Participants)
Latvia	27 9.1%
United States	166 56.1%
France	44 14.9%
Serbia	12 4.1%
Switzerland	4 1.4%
Germany	27 9.1%
Spain	16 5.4%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	29.46 (5.32)

Outcome Measures

1. Primary Outcome

Title	Target Vessel Failure (TVF)
Description	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.
Time Frame	270 days

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent System
Measure Participants	290
Number (95% Confidence Interval) [percentage of participants]	11.38 3.8%

2. Secondary Outcome

Title	All Cause Mortality
Description	Death from any cause
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	296
Count of Participants [Participants]	1 0.3%

3. Secondary Outcome

Title	All Cause Mortality
Description	Death from any cause
Time Frame	180 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent System
Measure Participants	294
Count of Participants [Participants]	5 1.7%

4. Secondary Outcome

Title	All Cause Mortality
Description	Death from any cause
Time Frame	270 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	294
Count of Participants [Participants]	6 2%

5. Secondary Outcome

Title	All Cause Mortality
Description	Death from any cause
Time Frame	360 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	291
Count of Participants [Participants]	7 2.4%

6. Secondary Outcome

Title	All Cause Mortality
Description	Death from any cause
Time Frame	1800 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	283
Count of Participants [Participants]	34 11.5%

7. Secondary Outcome

Title	Cardiac Mortality
Description	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
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	296
Count of Participants [Participants]	1 0.3%

8. Secondary Outcome

Title	Cardiac Mortality
Description	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
Time Frame	180 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	292
Count of Participants [Participants]	1 0.3%

9. Secondary Outcome

Title	Cardiac Mortality
Description	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
Time Frame	270 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	289
Count of Participants [Participants]	1 0.3%

10. Secondary Outcome

Title	Cardiac Mortality
Description	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
Time Frame	360 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	286
Count of Participants [Participants]	1 0.3%

11. Secondary Outcome

Title	Cardiac Mortality
Description	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
Time Frame	1800 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	259
Number (95% Confidence Interval) [percentage of participants]	3.99 1.3%

12. Secondary Outcome

Title	Major Adverse Cardiac Events (MACE)
Description	Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	296
Count of Participants [Participants]	19 6.4%

13. Secondary Outcome

Title	Major Adverse Cardiac Events (MACE)
Description	Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods
Time Frame	180 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	292
Count of Participants [Participants]	23 7.8%

14. Secondary Outcome

Title	Major Adverse Cardiac Events (MACE)
Description	Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods
Time Frame	270 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	289
Count of Participants [Participants]	29 9.8%

15. Secondary Outcome

Title	Major Adverse Cardiac Events (MACE)
Description	Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods
Time Frame	360 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	286
Count of Participants [Participants]	44 14.9%

16. Secondary Outcome

Title	Major Adverse Cardiac Events (MACE)
Description	Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods
Time Frame	1800 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	213
Number (95% Confidence Interval) [percentage of participants]	22 7.4%

17. Secondary Outcome

Title	Myocardial Infarction (MI-ARC Definition)
Description	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
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	295
Q-wave MI	0 0%
Non Q-wave MI	18 6.1%
MI-ARC Definition	18 6.1%

18. Secondary Outcome

Title	Myocardial Infarction (MI-ARC Definition)
Description	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
Time Frame	180 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	291
Q-wave MI	0 0%
Non Q-wave MI	18 6.1%
MI-ARC Definition	20 6.8%

19. Secondary Outcome

Title	Myocardial Infarction (MI-ARC Definition)
Description	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
Time Frame	270 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	288
Q-wave MI	0 0%
Non Q-wave MI	18 6.1%
MI-ARC Definition	20 6.8%

20. Secondary Outcome

Title	Myocardial Infarction (MI-ARC Definition)
Description	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
Time Frame	360 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	285
Q-wave MI	0 0%
Non Q-wave MI	21 7.1%
MI-ARC Definition	24 8.1%

21. Secondary Outcome

Title	Myocardial Infarction (MI-ARC Definition)
Description	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
Time Frame	1800 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	237
Number (95% Confidence Interval) [percentage of participants]	10.1 3.4%

22. Secondary Outcome

Title	Cardiac Death or MI (ARC Definition)
Description	Composite Endpoint of Cardiac Death or MI (ARC definition)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	296
Count of Participants [Participants]	19 6.4%

23. Secondary Outcome

Title	Cardiac Death or MI (ARC Definition)
Description	Composite Endpoint of Cardiac Death and MI (ARC definition)
Time Frame	180 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	292
Count of Participants [Participants]	19 6.4%

24. Secondary Outcome

Title	Cardiac Death or MI (ARC Definition)
Description	Composite Endpoint of Cardiac Death or MI (ARC definition)
Time Frame	270 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	289
Count of Participants [Participants]	19 6.4%

25. Secondary Outcome

Title	Cardiac Death or MI (ARC Definition)
Description	Composite Endpoint of Cardiac Death or MI (ARC definition)
Time Frame	360 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	286
Count of Participants [Participants]	25 8.4%

26. Secondary Outcome

Title	Clinically Driven TLR
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	295
Count of Participants [Participants]	0 0%

27. Secondary Outcome

Title	Clinically Driven TLR
Description	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.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	291
Count of Participants [Participants]	7 2.4%

28. Secondary Outcome

Title	Clinically Driven TLR
Description	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.
Time Frame	270 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	288
Count of Participants [Participants]	13 4.4%

29. Secondary Outcome

Title	Clinically Driven TLR (Clinical and Angiographic Cohorts)
Description	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.
Time Frame	360 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	285
Count of Participants [Participants]	27 9.1%

30. Secondary Outcome

Title	Clinically Driven TLR (Clinical Cohorts)
Description	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.
Time Frame	360 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	170
Count of Participants [Participants]	8 2.7%

31. Secondary Outcome

Title	Clinically Driven TLR (Clinical and Angiographic Cohorts)
Description	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.
Time Frame	1800 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	228
Number (95% Confidence Interval) [percentage of participants]	12 4.1%

32. Secondary Outcome

Title	Clinically Driven TLR (Clinical Cohorts)
Description	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.
Time Frame	1800 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	139
Number (95% Confidence Interval) [percentage of participants]	7.76 2.6%

33. Secondary Outcome

Title	Clinically Driven TVR
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	295
Count of Participants [Participants]	1 0.3%

34. Secondary Outcome

Title	Clinically Driven TVR
Description	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.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	291
Count of Participants [Participants]	9 3%

35. Secondary Outcome

Title	Clinically Driven TVR
Description	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.
Time Frame	270 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	289
Count of Participants [Participants]	17 5.7%

36. Secondary Outcome

Title	Clinically Driven TVR
Description	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.
Time Frame	360 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	286
Count of Participants [Participants]	34 11.5%

37. Secondary Outcome

Title	Target Vessel Failure (TVF)
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	296
Count of Participants [Participants]	20 6.8%

38. Secondary Outcome

Title	Target Vessel Failure (TVF)
Description	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.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	292
Count of Participants [Participants]	25 8.4%

39. Secondary Outcome

Title	Target Vessel Failure (TVF)
Description	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.
Time Frame	360 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	287
Count of Participants [Participants]	50 16.9%

40. Secondary Outcome

Title	Stroke (Ischemic and Hemorrhagic)
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	295
Count of Participants [Participants]	0 0%

41. Secondary Outcome

Title	Stroke (Ischemic and Hemorrhagic)
Description	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.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	292
Count of Participants [Participants]	1 0.3%

42. Secondary Outcome

Title	Stroke (Ischemic and Hemorrhagic)
Description	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.
Time Frame	270 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	289
Count of Participants [Participants]	1 0.3%

43. Secondary Outcome

Title	Device Success
Description	Attainment of <30% final residual stenosis of the target lesion using only the COBRA PzF Coronary Stent System
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	291
Count of Participants [Participants]	291 98.3%

44. Secondary Outcome

Title	Stroke (Ischemic and Hemorrhagic)
Description	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.
Time Frame	360 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	286
Count of Participants [Participants]	2 0.7%

45. Secondary Outcome

Title	Lesion Success
Description	Attainment of <30% final residual stenosis of the target lesion using any percutaneous method
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	292
Count of Participants [Participants]	254 85.8%

46. Secondary Outcome

Title	Procedure Success
Description	Attainment of <30% final residual stenosis of the target lesion and no in-hospital MACE
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	292
Count of Participants [Participants]	241 81.4%

47. Secondary Outcome

Title	Bleeding or Vascular Complications
Description	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
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	296
Count of Participants [Participants]	0 0%

48. Secondary Outcome

Title	Early Stent Thrombosis (ARC Definition)
Description	Early Stent Thrombosis (ARC Definition) 0-30 days post index procedure
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	295
Count of Participants [Participants]	0 0%

49. Secondary Outcome

Title	Late Stent Thrombosis
Description	Stent Thrombosis after 30 days and on or before 180 days
Time Frame	180 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	291
Count of Participants [Participants]	0 0%

50. Secondary Outcome

Title	Late Stent Thrombosis
Description	Stent Thrombosis after 30 days and on or before 270 days
Time Frame	270 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	288
Count of Participants [Participants]	0 0%

51. Secondary Outcome

Title	Late Stent Thrombosis
Description	Stent Thrombosis after 30 days and on or before 360 days
Time Frame	360 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	285
Count of Participants [Participants]	0 0%

52. Secondary Outcome

Title	Definite and Probable Stent Thrombosis
Description	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.
Time Frame	1800 days

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	259
Number (95% Confidence Interval) [percentage of participants]	0 0%

53. Secondary Outcome

Title	In-Segment Percent Diameter Stenosis
Description	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
Time Frame	270 days

Outcome Measure Data

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

Arm/Group Title	Angiographic Cohort
Arm/Group Description	A group of patients who underwent angiographic assessment after the clinical assessment at 270 days.
Measure Participants	115
In-Segment percent diameter stenosis (%DS)	38.34 (17.03)
In-Stent percent diameter stenosis (%DS)	36.89 (18.30)

54. Secondary Outcome

Title	In-Stent and In-Segment MLD and Late Loss
Description	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.
Time Frame	270 days

Outcome Measure Data

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

Arm/Group Title	Angiographic Cohort
Arm/Group Description	A group of patients who underwent an angiographic assessment after the clinical assessment at 270 days
Measure Participants	115
In-Stent Late Loss	0.83 (0.48)
In-segment late loss	0.52 (0.49)
In-stent minimum lumen diameter	1.78 (0.63)
In-segment minimum lumen diameter	1.72 (0.60)

55. Secondary Outcome

Title	Angiographic Endpoints
Description	Angiographic subset included 115 of the 296 enrolled. Therefore, the overall number of participants analyzed for this outcome measure is 115.
Time Frame	270 days

Outcome Measure Data

Analysis Population Description
Angiographic subset of patients

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent
Measure Participants	115
In-segment binary restenosis	28.57
In-stent binary angiographic restenosis	25.64
Stent fracture	0.00

56. Secondary Outcome

Title	In-stent Neointimal Thickness (INT)
Description	in-stent neointimal thickness assessed by Optical Coherence Tomography
Time Frame	270 days

Outcome Measure Data

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

Arm/Group Title	OCT Cohort
Arm/Group Description	A group of those patients who underwent OCT assessment after the clinical follow up at 270 days
Measure Participants	57
Mean (Standard Deviation) [mm]	0.33 (0.15)

57. Secondary Outcome

Title	Percentage of Uncovered and/or Malapposed Struts
Description	This measure assess the average proportion of uncovered and or malapposed struts measured by Optical Coherence Tomography in participants
Time Frame	270 days

Outcome Measure Data

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

Arm/Group Title	OCT Cohort
Arm/Group Description	A group of those patients who underwent OCT assessment after the clinical follow up at 270 days
Measure Participants	57
Mean (Standard Deviation) [% of Uncovered and/or Malapposed Struts]	0.00 (0.01)

58. Secondary Outcome

Title	Lumen and Stent Area Measurements
Description	Optical Coherence Tomography assessment of the lumen and stent area after the clinical follow up at 270 days
Time Frame	270 days

Outcome Measure Data

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

Arm/Group Title	OCT Cohort
Arm/Group Description	A group of those patients who underwent OCT assessment after the clinical follow up at 270 days
Measure Participants	57
Lumen Area	5.52 (2.52)
Stent Area	8.41 (2.69)

59. Secondary Outcome

Title	Lumen and Stent Volume
Description	Optical Coherence Tomography assessment of the lumen and stent volume after the clinical follow up at 270 days
Time Frame	270 days

Outcome Measure Data

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

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent System
Measure Participants	57
Lumen volume	97.44 (61.27)
Stent volume	149.06 (75.99)

Adverse Events

	COBRA PzF Stent
Time Frame	All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Adverse Event Reporting Description

Arm/Group Title	COBRA PzF Stent
Arm/Group Description	COBRA PzF Coronary Stent System
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	34/283 (12%)
Serious Adverse Events
	COBRA PzF Stent
	Affected / at Risk (%)	# Events
Total	87/296 (29.4%)
Cardiac disorders
Acute Coronary Syndrome	4/296 (1.4%)	4
Acute Myocardial Infarction	1/296 (0.3%)	1
Angina Pectoris	14/296 (4.7%)	15
Angina Unstable	1/296 (0.3%)	2
Atrial Fibrillation	8/296 (2.7%)	9
Atrial Flutter	1/296 (0.3%)	1
Bradycardia	1/296 (0.3%)	1
Cardiac Failure Congestive	2/296 (0.7%)	2
Cardiomyopathy	1/296 (0.3%)	1
Coronary Artery Disease	2/296 (0.7%)	2
Coronary Artery Stenosis	8/296 (2.7%)	9
Coronary Artery Thrombosis	1/296 (0.3%)	1
Myocardial Infarction	1/296 (0.3%)	1
Myocardial Ischaemia	2/296 (0.7%)	2
Ventricular Fibrillation	1/296 (0.3%)	1
Ear and labyrinth disorders
Vertigo	2/296 (0.7%)	2
Gastrointestinal disorders
Gastrointestinal Haemorrhage	1/296 (0.3%)	1
Gastrooesophagitis	1/296 (0.3%)	1
Ileus	1/296 (0.3%)	1
Intestinal Haemorrhage	1/296 (0.3%)	1
Intestinal Obstruction	1/296 (0.3%)	2
General disorders
Asthenia	1/296 (0.3%)	1
Chest Pain	1/296 (0.3%)	1
Impaired Healing	1/296 (0.3%)	1
Multi-Organ Failure	1/296 (0.3%)	1
Non-Cardiac Chest Pain	6/296 (2%)	7
Hepatobiliary disorders
Hepatic Cirrhosis	1/296 (0.3%)	1
Infections and infestations
Appendicitis Perforated	1/296 (0.3%)	1
Necrotising Fasciitis	1/296 (0.3%)	1
Nosocomial Infection	1/296 (0.3%)	1
Oophoritis	1/296 (0.3%)	1
Pneumonia	2/296 (0.7%)	2
Salpingitis	1/296 (0.3%)	1
Tonsillitis	1/296 (0.3%)	1
Injury, poisoning and procedural complications
Arterial Injury	1/296 (0.3%)	1
Arterial Restenosis	1/296 (0.3%)	1
Coronary Artery Restenosis	24/296 (8.1%)	25
Post Pocedural Hematoma	2/296 (0.7%)	2
Procedural Complication	1/296 (0.3%)	1
Vascular Access Complication	1/296 (0.3%)	1
Investigations
Blood Creatinine Phosphokinase Increased	1/296 (0.3%)	1
Cardiac Enzymes Increased	1/296 (0.3%)	1
Electrocardiogram Change	1/296 (0.3%)	1
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/296 (0.3%)	1
Pain in Extremity	1/296 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma	1/296 (0.3%)	1
Bile Duct Cancer	1/296 (0.3%)	1
Lung Adenocarcinoma Stage I	1/296 (0.3%)	1
Pleural Mesothelioma	1/296 (0.3%)	1
Nervous system disorders
Cerebrovascular Accident	1/296 (0.3%)	1
Dizziness	1/296 (0.3%)	1
Parkinsonian Gait	1/296 (0.3%)	1
Subarachnoid Haemorrhage	1/296 (0.3%)	1
Transient Ischemic Attack	1/296 (0.3%)	1
Vascular Dementia	1/296 (0.3%)	1
Renal and urinary disorders
Calculus Ureteric	1/296 (0.3%)	1
Renal Failure Acute	1/296 (0.3%)	1
Renal Mass	1/296 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure	1/296 (0.3%)	1
Chronic Obstructive Pulmonary Disease	1/296 (0.3%)	1
Skin and subcutaneous tissue disorders
Urticaria	1/296 (0.3%)	1
Vascular disorders
Arterial Stenosis	1/296 (0.3%)	1
Haematoma	1/296 (0.3%)	1
Hypotension	1/296 (0.3%)	1
Intermittent Claudication	1/296 (0.3%)	2
Peripheral Vascular Disorder	2/296 (0.7%)	2
Other (Not Including Serious) Adverse Events
	COBRA PzF Stent
	Affected / at Risk (%)	# Events
Total	0/296 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title	Mark Barakat, MD
Organization	CeloNova BioSciences Inc.
Phone	(210) 489-4004
Email	mbarakat@celonova.com

Responsible Party:

CeloNova BioSciences, Inc.

ClinicalTrials.gov Identifier:

NCT01925794

Other Study ID Numbers:

COBRA 2012-01

First Posted:

Aug 20, 2013

Last Update Posted:

Dec 22, 2021

Last Verified:

Mar 1, 2021