Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF)

Post-marketing Clinical Follow-up Study With Coroflex® ISAR Neo

The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions.

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.

Inclusion 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.

Exclusion Criteria:

• 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
• Cardiogenic shock
• 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