Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF)
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The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions.
Condition or disease
Coronary Artery Disease
Device: Coroflex® ISAR NEO coronary stent system
Post-authorisation / after Conformité Européene (CE) marking Coroflex® ISAR NEO is a drug eluting stent system which is an improved version of the predecessor device Coroflex® ISAR which was extensively studied in the ISAR 2000 Registry. The rationale of this observational, post-market, single-armed study is to confirm the safety and efficacy of Coroflex® ISAR NEO, also as part of the manufacturer's post-market surveillance obligations in particular for the re-certification of the device.
Target Lesion Revascularization (TLR) rate at 12 months [ Time Frame: 12 months ]
Secondary Outcome Measures :
Accumulated Major Adverse Cardiovascular Events (MACE) rate at 12 months (including intra-hospital events) [ Time Frame: 12 months ]
MACE consists of all events TLR (Re-Percutaneous Coronary Intervention (Re-PCI), Coronary Artery Bypass Grafting (CABG)), Myocardial Infarction (MI), cardiac death (inhospital) and all-cause death up to 12 months. MI is defined as a new event documented with elevated cardiac enzymes during the follow-up. Elevated enzyme levels during the hospital stay are not considered as a new event.
Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events) [ Time Frame: 12 months ]
Stent thrombosis rates accumulated up to 12 months [ Time Frame: 12 months ]
Stent thrombosis is defined as thrombosis in the treated coronary lesion only. No venous thrombotic events are relevant for this end point.
Rate of bleeding complications accumulated up to 12 months [ Time Frame: 12 months ]
To assess the bleeding complications the Bleeding Academic Research Consortium (BARC) scale will be used.
Technical/procedural success rate [ Time Frame: immediately after procedure ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
The investigator of each study site has the responsibility of screening all potential patients and selecting those who fulfil the inclusion criteria of this study protocol. Therefore, at each site a study with similar inclusion criteria cannot be conducted while the recruitment of this study is in progress.
Screening will be performed during the physical examination to verify the "patient related enrolment criteria". The second part of the screening procedure will be completed during the diagnostic angiography to verify that the target lesion fulfils all "lesion related enrolment criteria".
Coroflex® ISAR NEO is intended to be used for
All common significant coronary lesions
Target lesion length >34mm need to be covered with at least 2 stents
Patients eligible for this study must be at least 18 years of age.
The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment.
Intolerance to sirolimus and/or probucol
Allergy to components of the coating
Pregnancy and lactation
Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized
Risk of an intraluminal thrombus
Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
Severe allergy to contrast media
Lesions which are untreatable with PCI or other interventional techniques
Patients with an ejection fraction of < 30 %
Vascular reference diameter < 2.00 mm
Treatment of the left stem (first section of the left coronary artery)
Indication for a bypass surgery
Contraindication for whichever accompanying medication is necessary