The study will evaluate the performance and safety of RisoR Crest Everolimus Eluting Coronary Stent System. A total of 2000 participants will be included in the study from India and Italy.
Age more than 18 years
All Genders (Males, Females, Transgenders, Non binary)
Patient or legally authorized representative (LAR) agrees to participate by signing the informed consent form.
Patient with coronary artery disease eligible for percutaneous coronary intervention (PCI) as per regional or hospital's standard practices guidelines for PCI (For Europe, as per ESC guidelines)
Pregnant and lactating females
Candidates for emergency bypass Surgery
Patients corresponding to the criteria of a vulnerable population (Vulnerable subjects, including patients who are unable to fully understand all aspects of the investigation, patients who could be manipulated or unduly influenced, patients lacking capacity in the informed consent procedure and patients with dementia and cognitive impairment, patients under social security, imprisonment etc.)
Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) less than 30 Percent
Single group
Coronary Stent
DeviceRisoR Crest Everolimus Eluting Coronary Stent System
Target Lesion Failure (TLF)
Target Lesion Failure (TLF) defined as a hierarchical composite of Cardiac Death, Target Vessel oriented Myocardial Infarction (TV-MI) and Clinically indicated Target Lesion Revascularization (Ci-TLR) at 360 days following implantation of RisoR Crest Everolimus Eluting Coronary Stent System.
Incidence of TLF (Equivalent of DoCE)
1. Cardiovascular Death 2. Target vessel Myocardial Infarction (TV-MI) and 3. Clinically indicated Target Lesion Revascularization (Ci-TLR).
Incidence of POCE
1. All cause death 2. Any stroke 3. Any myocardial infarction (includes non-target vessel territory) 4. Any revascularization
Incidence of MACE
1. Cardiovascular death 2. Myocardial Infarction (MI) 3. Target Vessel Revascularization (TVR)
Target Vessel Failure (TVF)
Target Vessel Failure (TVF)
QCA Endpoints
In-stent and in-segment % diameter stenosis (DS)
QCA Endpoints
Minimum Lumen Diameter (MLD)
QCA Endpoints
Late Lumen Loss
QCA Endpoints
Angiographic binary restenosis
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