Coronary Artery DiseaseNCT01925794
COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT
A study testing COBRA PzF in people with Coronary Artery Disease, run by CeloNova BioSciences, Inc. at 35 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- COBRA PzF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 35 sitesin 7 countries
- Study dates
- 21 Aug 2013to 2 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
35 sites in 7 countries.
35 sites in 7 countries
United States22 sites
Emory University Hospital
Atlanta, Georgia, 30322
Bakersfield Memorial Hospital
Bakersfield, California, 93303
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Deborah Heart & Lung Center
Browns Mills, New Jersey, 08015
Cardiology Consultants of Texas
Dallas, Texas, 75226
Plaza Medical Center
Fort Worth, Texas, 76104
Houston Methodist Hospital
Houston, Texas, 77030
Heart Center of Indiana
Indianapolis, Indiana, 46290
Louisiana Heart Hospital
Lacombe, Louisiana, 70445
St Joseph's Hospital
Liverpool, New York, 13088
Texas Cardiac Center
Lubbock, Texas, 79410
Southern Oregon Cardiology
Medford, Oregon, 97504
Mt Sinai Medical Center
Miami Beach, Florida, 33140
Lenox Hill Hospital
New York, New York, 10075
Mount Sinai Hospital
New York, New York, 11029
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73120
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Virginia Cardiovascular Specialists
Richmond, Virginia, 23229
San Antonio Endovascular & Heart Institute
San Antonio, Texas, 78258
Tyler Cardiovascular Consultants
Tyler, Texas, 75701
Aspirus Heart & Vascular Institute
Wausau, Wisconsin, 54401
York General Hospital
York, Pennsylvania, 17403
France6 sites
Clinique Axium
Aix-en-Provence, 13097
Hopital Henri Duffaut
Avignon, 84902
Albert Schweitzer Hospital
Colmar, 68000
Clinique du Diaconat
Mulhouse, 68100
Centre Hospitalier de Pau
Pau, 64046
Clinique St. Hilaire
Rouen, 76600
Germany2 sites
Sankt Kathatinen Hospital
Frankfurt, 60389
Kardiologische Praxis und Praxisklinik
München, 81379
Spain2 sites
Hospital de la Santa Creu
Barcelona, 08025
Hospital Clinico San Carlos
Madrid, 28040
About this study
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
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.
Read the 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
- Conditions
- Coronary Artery Disease
- Being tested
- COBRA PzF
- Keywords
- Stent, Coronary Arteries for Early healing
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COBRA PzFDevice
| Study group | Role | What they receive |
|---|---|---|
| COBRA PzF Stent | Experimental | Single Arm study Receives: Device: COBRA PzF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 270 days
Secondary outcomes (58)
All Cause Mortality
Death from any cause
Measured: 30 days
All Cause Mortality
Death from any cause
Measured: 180 days
All Cause Mortality
Death from any cause
Measured: 270 days
All Cause Mortality
Death from any cause
Measured: 360 days
All Cause Mortality
Death from any cause
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1800 days
Cardiac Death or MI (ARC Definition)
Composite Endpoint of Cardiac Death or MI (ARC definition)
Measured: 30 days
Cardiac Death or MI (ARC Definition)
Composite Endpoint of Cardiac Death and MI (ARC definition)
Measured: 180 days
Cardiac Death or MI (ARC Definition)
Composite Endpoint of Cardiac Death or MI (ARC definition)
Measured: 270 days
Cardiac Death or MI (ARC Definition)
Composite Endpoint of Cardiac Death or MI (ARC definition)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 270 days
Device Success
Attainment of <30% final residual stenosis of the target lesion using only the COBRA PzF Coronary Stent System
Measured: 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.
Measured: 360 days
Lesion Success
Attainment of <30% final residual stenosis of the target lesion using any percutaneous method
Measured: 30 days
Procedure Success
Attainment of <30% final residual stenosis of the target lesion and no in-hospital MACE
Measured: 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
Measured: 30 days
Early Stent Thrombosis (ARC Definition)
Early Stent Thrombosis (ARC Definition) 0-30 days post index procedure
Measured: 30 days
Late Stent Thrombosis
Stent Thrombosis after 30 days and on or before 180 days
Measured: 180 days
Late Stent Thrombosis
Stent Thrombosis after 30 days and on or before 270 days
Measured: 270 days
Late Stent Thrombosis
Stent Thrombosis after 30 days and on or before 360 days
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 270 days
In-stent Neointimal Thickness (INT)
in-stent neointimal thickness assessed by Optical Coherence Tomography
Measured: 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
Measured: 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
Measured: 270 days
Lumen and Stent Volume
Optical Coherence Tomography assessment of the lumen and stent volume after the clinical follow up at 270 days
Measured: 270 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study start21 Aug 2013
- Primary completionNov 2015
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- CeloNova BioSciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald Cutlip, MD, Principal investigator, Executive Director, Clinical Investigation, Harvard Clinical Research InstituteSigmund Sliber, MD, Principal investigator, Professor of Medicine at The University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925794
- Sponsor's protocol ID
- COBRA 2012-01
- Status last verified
- Mar 2021
- First submitted
- 9 Aug 2013
- Last updated
- 22 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01925794
- Acronym / sponsor ID
- COBRA 2012-01
- Conditions
- Coronary Artery Disease
- Keywords
- Stent, Coronary Arteries for Early healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- CeloNova BioSciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Posted 22 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COBRA PzF Stent | Experimental | Device: COBRA PzFSingle Arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COBRA PzF | Device | COBRA PzF Stent |
Primary outcome
Target Vessel Failure (TVF)
Time frame: 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.
58 secondary outcomes
All Cause Mortality
Time frame: 30 days
All Cause Mortality
Time frame: 180 days
All Cause Mortality
Time frame: 270 days
All Cause Mortality
Time frame: 360 days
All Cause Mortality
Time frame: 1800 days
Cardiac Mortality
Time frame: 30 days
Cardiac Mortality
Time frame: 180 days
Cardiac Mortality
Time frame: 270 days
Cardiac Mortality
Time frame: 360 days
Cardiac Mortality
Time frame: 1800 days
Major Adverse Cardiac Events (MACE)
Time frame: 30 days
Major Adverse Cardiac Events (MACE)
Time frame: 180 days
Major Adverse Cardiac Events (MACE)
Time frame: 270 days
Major Adverse Cardiac Events (MACE)
Time frame: 360 days
Major Adverse Cardiac Events (MACE)
Time frame: 1800 days
Myocardial Infarction (MI-ARC Definition)
Time frame: 30 days
Myocardial Infarction (MI-ARC Definition)
Time frame: 180 days
Myocardial Infarction (MI-ARC Definition)
Time frame: 270 days
Myocardial Infarction (MI-ARC Definition)
Time frame: 360 days
Myocardial Infarction (MI-ARC Definition)
Time frame: 1800 days
Cardiac Death or MI (ARC Definition)
Time frame: 30 days
Cardiac Death or MI (ARC Definition)
Time frame: 180 days
Cardiac Death or MI (ARC Definition)
Time frame: 270 days
Cardiac Death or MI (ARC Definition)
Time frame: 360 days
Clinically Driven TLR
Time frame: 30 days
Clinically Driven TLR
Time frame: 180 days
Clinically Driven TLR
Time frame: 270 days
Clinically Driven TLR (Clinical and Angiographic Cohorts)
Time frame: 360 days
Clinically Driven TLR (Clinical Cohorts)
Time frame: 360 days
Clinically Driven TLR (Clinical and Angiographic Cohorts)
Time frame: 1800 days
Clinically Driven TLR (Clinical Cohorts)
Time frame: 1800 days
Clinically Driven TVR
Time frame: 30 days
Clinically Driven TVR
Time frame: 180 days
Clinically Driven TVR
Time frame: 270 days
Clinically Driven TVR
Time frame: 360 days
Target Vessel Failure (TVF)
Time frame: 30 days
Target Vessel Failure (TVF)
Time frame: 180 days
Target Vessel Failure (TVF)
Time frame: 360 days
Stroke (Ischemic and Hemorrhagic)
Time frame: 30 days
Stroke (Ischemic and Hemorrhagic)
Time frame: 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Cutlip, MD principal investigator
Executive Director, Clinical Investigation, Harvard Clinical Research Institute
Sigmund Sliber, MD principal investigator
Professor of Medicine at The University of Munich
35 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COBRA PzF in people with Coronary Artery Disease, run by CeloNova BioSciences, Inc. at 35 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, France, Germany, Spain, Latvia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Vessel Failure (TVF) (time frame: 270 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.