Coroflex® ISAR NEO PMCF Study

Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study

International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.

The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system Sirolimus Eluting Stent in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Inclusion Criteria:

Coroflex® ISAR NEO is intended to be used for

• Patients must be at least 18 years of age AND
• 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 AND
• Patients with Novo lesion length 2-4 mm AND
• Informed consent signed

Exclusion Criteria:

• Patients with express refusal by the patient to participate in the study.
• Patients pregnant women and lactating women.
• Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).
• Patients in whom anti-platelet and/or anti-coagulation therapy is contraindicated
• Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation
• Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent
• Patients with known sensitivity to contrast agents who cannot be premedicated.
• Patients with contraindications or hypersensitivity to sirolimus
• Patients with a life expectancy of less than 2 years
• Patients included in other clinical trials