To Evaluate the Performance and Safety of RisoR Crest Everolimus Eluting Coronary Stent System

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorPoly Medicure Limited

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

Treatment groups

2,000 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators