e-NOBORI Observational Registry of Nobori DES

Study Overview
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Brief Summary
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Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients. Objective Primary objective The primary objective of e-NOBORI registry is to further validate the safety and efficacy of Nobori® DES system in unselected patients representing everyday clinical practice. Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year

Detailed Description
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Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients. Primary objective The primary objective of e-NOBORI registry is to further validate the safety and efficacy of Nobori® DES system in unselected patients representing everyday clinical practice. Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year Clinical Site Locations: Up to 200 centres across Europe, Asia and Central and South America -Patient Population :  18000 eligible patients suitable for treatment with the Nobori® DES will be entered in the e-NOBORI registry Eligibility Criteria Patient is more or equal 18 years old; Patient is, according to hospital routine practice, eligible for percutaneous coronary intervention using DES (and RVD matches available Nobori® DES sizes); Patient has been informed of the nature of the study and agrees to its provisions, has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site, wherever such requirement exists. NOTE: In order to avoid bias it is recommended that all investigators aim to enrol all consecutive patients complying with study eligibility criteria. It is also desirable to have at least two cardiologists as investigators in each centre. According to pre-specified criteria, patients will be automatically allocated to one or more sub-studies as following: NOBORI Acute Coronary Syndrome NOBORI Stable angina NOBORI Female NOBORI Bifurcation NOBORI Diabetes Insulin Dependent Diabetes Mellitus (IDDM) Non-Insulin Dependent Diabetes Mellitus (NIDDM) NOBORI Small Vessels (less or equal 2.75mm) NOBORI Long Lesions (more or equal 20mm) NOBORI Renal Insufficiency (> 2.0 mg/dL - 176 µmol/mL) NOBORI Elderly (more or equal 80 years of age) NOBORI Restenosis NOBORI Multivessel Treatment NOBORI Complex Lesions In addition to above mentioned sub-studies there will be geographic sub-studies for the main areas. Medication Pre-Procedure: According to hospital routine practice Post-Procedure: Mandatory antiplatelet treatment, according to hospital routine practice (minimum 6 months DAT)

Official Title
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Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is more or equal 18 years old; Patient is, according to hospital routine practice, eligible for percutaneous coronary intervention using DES (and RVD matches available Nobori® DES sizes); Patient has been informed of the nature of the study and agrees to its provisions, has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site, wherever such requirement exists. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stable angina<br>Patient admitted with stable angina | |
| Acute Coronary Syndrome<br>Patients admitted with Acute Coronary Syndrome | |
| Female<br>Participant female patients | |
| Bifurcation<br>One or more lesions treated during the baseline in bifurcation | |
| Insulin Dependent Diabetes Mellitus<br>Patients that were insulin-dependent diabetes mellitus at admission | |
| Non-Insulin Dependent Diabetes Mellitus<br>Patients that were non-insulin-dependent diabetes mellitus at admission | |
| Small Vessels<br>vessels smaller or equal to 2.75mm | |
| NOBORI Long Lesions<br>Lesions longer or equal to 20mm | |
| Renal Insufficiency<br>Patients that at admission had renal insufficiency (> 2.0 mg/dL - 176 µmol/mL) at admission | |
| Elderly<br>Patients more or equal 80 years old | |
| Restenosis<br>One or more lesions treated during the baseline in were restenotic lesions | |
| Multivessel Treatment<br>Patients who underwent the treatment of more than 1 vessel during the index procedure | |
| Complex Lesions<br>Patients who underwent a PCI on the Left Main Trunk, on a Chronic Total Occluded lesion or located on a Saphenous Vein Graft | |
| Overall<br>Total Population | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FREEDOM OF TARGET LESION FAILURE | TLF: COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION | 1 YEAR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Procedural success is defined as achievement of a diameter of stenosis of <30% by visual assessment and/or <50% by QCA, using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesión during the hospital stay. | 1 MONTH | 
| Device success | Device Success defined as attainment of a final residual diameter stenosis of the target lesion of < 30% by visual assessment and/or < 50% by QCA, using the assigned device only. Device Success defined as attainment of a final residual diameter stenosis of the target lesion of < 30% by visual assessment and/or < 50% by QCA, using the assigned device only. Device success is defined as attainment of a final residual diameter stenosis of the target lesión of <30% by visual assessment and/or >50% QCA, using the assigned device only. | 1 MONTH | 
| Acute/subacute stent thrombosis | (definite/probable according to ARC definitions) | 1 MONTH | 
| Peri-procedural myocardial infarction | Peri-procedural myocardial infarction | 1 MONTH | 
| Rate of Major Adverse Cardiac Events (MACE) | Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, MI or clinically driven target vessel revascularization (TVR) | 1 MONTH | 
| Major vascular and bleeding complications | NOT CABG RELATED | 1 MONTH | 
| Cardiac death/ Myocardial Infarction | Cardiac death/ Myocardial Infarction | 1 AND 2 YEARS | 
| Clinically driven target lesion revascularization (TLR) | re-PCI or CABG involving target lesion | 1 & 2 YEARS | 
| Stent thrombosis | (definite/probable; ARC definition) | 1 AND 2 YEARS | 
| Clinically driven target vessel revascularization (TVR) | PCI AND CABG | 1 AND 2 YEARS | 
| Target Lesion Failure (TLF) | Defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization | 1 MONTH AND 2 YEARS | 
| Patient Oriented Composite Endpoint defined as any cause of mortality, MI (Q-wave and non Q-wave), or any TVR | Patient Oriented Composite Endpoint defined as any cause of mortality, MI (Q-wave and non Q-wave), or any TVR | 1 MONTH, 1 AND 2 YEARS | 
| Composite Endpoint of Cardiac death and MI | Composite Endpoint of Cardiac death and MI | 1 MONTH, 1 AND 2 YEARS | 
| Composite Endpoint of Cardiac death and post-procedural MI | Composite Endpoint of Cardiac death and post-procedural MI | 1 month, 1 and 2 years post-procedure | 
| Stent thrombosis | definite and probable according to ARC definitions | 1 month, 1 and 2 years post-procedure | 
| Primary Stent thrombosis | definite and probable according to ARC definitions | 1 month, 1 and 2 years post-procedure | 
| Secondary Stent thrombosis | definite and probable according to ARC definitions | 1 month, 1 and 2 years post-procedure | 
| Duration of dual antiplatelet therapy | Duration of dual antiplatelet therapy | UP TO 2 YEARS | 
| Composite Endpoint of Cardiac death, post-procedural MI and stent thrombosis rate during the course of DAT versus the same events after cessation of DAT | Composite Endpoint of Cardiac death, post-procedural MI and stent thrombosis rate during the course of DAT versus the same events after cessation of DAT | UP TO 2 YEARS | 
| Clinically driven Target Lesion Revascularization | Clinically driven Target Lesion Revascularization | 1 MONTH | 
| Clinically driven Target Vessel Revascularization | Clinically driven Target Vessel Revascularization | 1 MONTH | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, observational registry