About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Coronary Stent