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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: COBRA PzF

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

1. All Death at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
2. Cardiac Death at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
3. 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
4. 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
5. Clinically driven TLR at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
6. Stroke (ischemic and hemorrhagic) at 30, 180, 270 and 360 days
7. Clinically driven TVR at 30, 180, 270 and 360 days
8. Composite Endpoint of Cardiac Death and MI at 30, 180, 270, and 360 days
9. TVF at 30, 180, and 360 days

10. Acute Success Rates

    1. Device Success: Attainment of < 30% final residual stenosis of the target lesion using only the COBRA PzFTM Coronary Stent System.
    2. Lesion Success: Attainment of < 30% final residual stenosis of the target lesion using any percutaneous method.
    3. Procedure Success: Attainment of < 30% final residual stenosis of the target lesion and no in-hospital MACE.
11. Bleeding or Vascular Complications at hospital discharge
12. Early Stent Thrombosis (ARC defined) at 30 days
13. Late Stent Thrombosis at 180, 270, and 360 days

14. Angiographic Endpoints (on first 90 evaluable patients) at 270 days (after clinical assessment)

    1. In-stent late loss (Secondary Endpoint hypothesis)
    2. In-segment percent diameter stenosis (%DS) (within the 5 mm margins proximal and distal to stent)
    3. In-stent percent diameter stenosis (%DS)
    4. In-segment late loss
    5. In-segment binary restenosis (stenosis of > 50% of the reference vessel diameter)
    6. In-stent binary restenosis
    7. In-stent minimum lumen diameter (MLD)
    8. In-segment MLD
    9. Longitudinal stent deformation
    10. Stent fracture

15. Optical Coherence Tomography Endpoints (on 45 subjects) at 270 days (after clinical assessment)

    1. in-stent neointimal thickness (NT)
    2. Lumen area
    3. Lumen volume
    4. Stent area
    5. Stent volume
    6. Proportion of uncovered and/or malopposed struts
    7. Stent fracture

• Study Type: Interventional
• Enrollment (Actual): 296
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aix en Provence, France, 13097
    • Clinique Axium
  • Avignon, France, 84902
    • Hôpital Henri Duffaut
  • Colmar, France, 68000
    • Albert Schweitzer Hospital
  • Mulhouse, France, 68100
    • Clinique du Diaconat
  • Pau, France, 64046
    • Centre Hospitalier De Pau
  • Rouen, France, 76600
    • Clinique St. Hilaire
• Germany
  • Frankfurt, Germany, 60389
    • Sankt Kathatinen Hospital
  • Munchen, Germany, 81379
    • Kardiologische Praxis und Praxisklinik
• Latvia
  • Riga, Latvia, 2166
    • Paul Stradins Clinical University hospital
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
• Switzerland
  • St. Gallen, Switzerland, CH-9007
    • Kantonsspital St. Gallen
• United States
  • California
    • Bakersfield, California, United States, 93303
      • Bakersfield Memorial Hospital
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Mt Sinai Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Heart Center of Indiana
  • Louisiana
    • Lacombe, Louisiana, United States, 70445
      • Louisiana Heart Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart & Lung Center
  • New York
    • Liverpool, New York, United States, 13088
      • St Joseph's Hospital
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
    • New York, New York, United States, 11029
      • Mount Sinai Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Foundation for Cardiovascular Research
  • Oregon
    • Medford, Oregon, United States, 97504
      • Southern Oregon Cardiology
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • York General Hospital
  • Texas
    • Dallas, Texas, United States, 75226
      • Cardiology Consultants of Texas
    • Fort Worth, Texas, United States, 76104
      • Plaza Medical Center
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Lubbock, Texas, United States, 79410
      • Texas Cardiac Center
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
    • San Antonio, Texas, United States, 78258
      • San Antonio Endovascular & Heart Institute
    • Tyler, Texas, United States, 75701
      • Tyler Cardiovascular Consultants
  • Virginia
    • Richmond, Virginia, United States, 23229
      • Virginia Cardiovascular Specialists
  • Wisconsin
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Heart & Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

General Inclusion Criteria:

1. Patient >/= to 18 years old.
2. Eligible for percutaneous coronary intervention (PCI).
3. Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
4. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
5. Acceptable candidate for coronary artery bypass graft (CABG) surgery.
6. 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).
7. 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

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

General Exclusion Criteria:

1. 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.
2. Previously enrolled in another stent trial within the prior 2 years.
3. ANY planned elective surgery or percutaneous intervention within the subsequent 3 months.
4. A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
5. The patient requires staged procedure of either the target or any non-target vessel within 9 months post-procedure.
6. 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.).
7. Previous drug eluting stent (DES) deployment anywhere in the target vessel.
8. Any previous stent placement within 15 mm (proximal or distal) of the target lesion.
9. 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.
10. Concurrent medical condition with a life expectancy of less than 12 months.
11. Documented left ventricular ejection fraction (LVEF) < 30% within 12 months prior to enrollment.
12. 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
13. Previous brachytherapy in the target vessel.
14. History of cerebrovascular accident or transient ischemic attack in the last 6 months.
15. Leukopenia (leukocytes < 3.5 x 10(9) / liter).
16. Neutropenia (Absolute Neutrophil Count < 1000/mm3) </= 3 days prior to enrollment.
17. Thrombocytopenia (platelets < 100,000/mm3) pre-procedure.
18. Active peptic ulcer or active GI bleeding.
19. History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
20. 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.
21. Serum creatinine level > 2.0 mg/dl within 7 days prior to index procedure.
22. Patients unable to tolerate dual anti-platelets therapy (DAPT) for one month post procedure.

Angiographic Exclusion Criteria

1. 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).
2. 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.
3. Target lesion (or vessel) exhibiting an intraluminal thrombus (occupying > 50% of the true lumen diameter) at any time.
4. Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
5. Target lesion with side branches > 2.0mm in diameter.
6. Target vessel is excessively tortuous (two bends > 90˚ to reach the target lesion).
7. Target lesion is severely calcified.
8. TIMI flow 0 or 1
9. Target lesion is in a bypass graft

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: August 21, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): March 2, 2020

Study Registration Dates

• First Submitted: August 9, 2013
• First Submitted That Met QC Criteria: August 16, 2013
• First Posted (Estimate): August 20, 2013

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Stent, Coronary Arteries for Early healing
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: COBRA 2012-01