Back to resultsCOBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
COBRA PzF
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Stent, Coronary Arteries for Early healing
Eligibility Criteria
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
Sites / Locations
- Bakersfield Memorial Hospital
- Mt Sinai Medical Center
- Emory University Hospital
- Heart Center of Indiana
- Louisiana Heart Hospital
- Beth Israel Deaconess Medical Center
- Deborah Heart & Lung Center
- St Joseph's Hospital
- Lenox Hill Hospital
- Mount Sinai Hospital
- Oklahoma Foundation for Cardiovascular Research
- Southern Oregon Cardiology
- York General Hospital
- Cardiology Consultants of Texas
- Plaza Medical Center
- Houston Methodist Hospital
- Texas Cardiac Center
- The Heart Hospital Baylor Plano
- San Antonio Endovascular & Heart Institute
- Tyler Cardiovascular Consultants
- Virginia Cardiovascular Specialists
- Aspirus Heart & Vascular Institute
- Clinique Axium
- Hopital Henri Duffaut
- Albert Schweitzer Hospital
- Clinique du Diaconat
- Centre Hospitalier de Pau
- Clinique St. Hilaire
- Sankt Kathatinen Hospital
- Kardiologische Praxis und Praxisklinik
- Paul Stradins Clinical University Hospital
- Clinical Center of Serbia
- Hospital de la Santa Creu
- Hospital Clinico San Carlos
- Kantonsspital St. Gallen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COBRA PzF Stent
Arm Description
Single Arm study
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
All Cause Mortality
Death from any cause
All Cause Mortality
Death from any cause
All Cause Mortality
Death from any cause
All Cause Mortality
Death from any cause
All Cause Mortality
Death from any cause
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Cardiac Death or MI (ARC Definition)
Composite Endpoint of Cardiac Death or MI (ARC definition)
Cardiac Death or MI (ARC Definition)
Composite Endpoint of Cardiac Death and MI (ARC definition)
Cardiac Death or MI (ARC Definition)
Composite Endpoint of Cardiac Death or MI (ARC definition)
Cardiac Death or MI (ARC Definition)
Composite Endpoint of Cardiac Death or MI (ARC definition)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Device Success
Attainment of <30% final residual stenosis of the target lesion using only the COBRA PzF Coronary Stent System
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.
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
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)
Early Stent Thrombosis (ARC Definition) 0-30 days post index procedure
Late Stent Thrombosis
Stent Thrombosis after 30 days and on or before 180 days
Late Stent Thrombosis
Stent Thrombosis after 30 days and on or before 270 days
Late Stent Thrombosis
Stent Thrombosis after 30 days and on or before 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.
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
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.
Angiographic Endpoints
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)
in-stent neointimal thickness assessed by Optical Coherence Tomography
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
Lumen and Stent Area Measurements
Optical Coherence Tomography assessment of the lumen and stent area after the clinical follow up at 270 days
Lumen and Stent Volume
Optical Coherence Tomography assessment of the lumen and stent volume after the clinical follow up at 270 days
Full Information
NCT ID
NCT01925794
First Posted
August 9, 2013
Last Updated
November 23, 2021
Sponsor
CeloNova BioSciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01925794
Brief Title
COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT
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 Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 21, 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
March 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CeloNova BioSciences, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Stent, Coronary Arteries for Early healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
296 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COBRA PzF Stent
Arm Type
Experimental
Arm Description
Single Arm study
Intervention Type
Device
Intervention Name(s)
COBRA PzF
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
Title
All Cause Mortality
Description
Death from any cause
Time Frame
30 days
Title
All Cause Mortality
Description
Death from any cause
Time Frame
180 days
Title
All Cause Mortality
Description
Death from any cause
Time Frame
270 days
Title
All Cause Mortality
Description
Death from any cause
Time Frame
360 days
Title
All Cause Mortality
Description
Death from any cause
Time Frame
1800 days
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Title
Cardiac Death or MI (ARC Definition)
Description
Composite Endpoint of Cardiac Death or MI (ARC definition)
Time Frame
30 days
Title
Cardiac Death or MI (ARC Definition)
Description
Composite Endpoint of Cardiac Death and MI (ARC definition)
Time Frame
180 days
Title
Cardiac Death or MI (ARC Definition)
Description
Composite Endpoint of Cardiac Death or MI (ARC definition)
Time Frame
270 days
Title
Cardiac Death or MI (ARC Definition)
Description
Composite Endpoint of Cardiac Death or MI (ARC definition)
Time Frame
360 days
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Title
Lesion Success
Description
Attainment of <30% final residual stenosis of the target lesion using any percutaneous method
Time Frame
30 days
Title
Procedure Success
Description
Attainment of <30% final residual stenosis of the target lesion and no in-hospital MACE
Time Frame
30 days
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
Title
Early Stent Thrombosis (ARC Definition)
Description
Early Stent Thrombosis (ARC Definition) 0-30 days post index procedure
Time Frame
30 days
Title
Late Stent Thrombosis
Description
Stent Thrombosis after 30 days and on or before 180 days
Time Frame
180 days
Title
Late Stent Thrombosis
Description
Stent Thrombosis after 30 days and on or before 270 days
Time Frame
270 days
Title
Late Stent Thrombosis
Description
Stent Thrombosis after 30 days and on or before 360 days
Time Frame
360 days
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
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
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
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
Title
In-stent Neointimal Thickness (INT)
Description
in-stent neointimal thickness assessed by Optical Coherence Tomography
Time Frame
270 days
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Cutlip, MD
Organizational Affiliation
Executive Director, Clinical Investigation, Harvard Clinical Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sigmund Sliber, MD
Organizational Affiliation
Professor of Medicine at The University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bakersfield Memorial Hospital
City
Bakersfield
State/Province
California
ZIP/Postal Code
93303
Country
United States
Facility Name
Mt Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Louisiana Heart Hospital
City
Lacombe
State/Province
Louisiana
ZIP/Postal Code
70445
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Deborah Heart & Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
St Joseph's Hospital
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
11029
Country
United States
Facility Name
Oklahoma Foundation for Cardiovascular Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Southern Oregon Cardiology
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
York General Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Cardiology Consultants of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Plaza Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Cardiac Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
San Antonio Endovascular & Heart Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Tyler Cardiovascular Consultants
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Virginia Cardiovascular Specialists
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Aspirus Heart & Vascular Institute
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Clinique Axium
City
Aix en Provence
ZIP/Postal Code
13097
Country
France
Facility Name
Hopital Henri Duffaut
City
Avignon
ZIP/Postal Code
84902
Country
France
Facility Name
Albert Schweitzer Hospital
City
Colmar
ZIP/Postal Code
68000
Country
France
Facility Name
Clinique du Diaconat
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Facility Name
Centre Hospitalier de Pau
City
Pau
ZIP/Postal Code
64046
Country
France
Facility Name
Clinique St. Hilaire
City
Rouen
ZIP/Postal Code
76600
Country
France
Facility Name
Sankt Kathatinen Hospital
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Kardiologische Praxis und Praxisklinik
City
Munchen
ZIP/Postal Code
81379
Country
Germany
Facility Name
Paul Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
2166
Country
Latvia
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Hospital de la Santa Creu
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT
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