An observational registry study of Eternia Coronary Stent Systemin coronary artery diseased patients of Indian populatio

Not Applicable

Conditions: Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery

Registration Number: CTRI/2023/10/058735

Lead Sponsor: Innvolution Healthcare Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients with ages more than 18 years.

2.Males or non-pregnant females.

3.Patient or legally authorized representative (LAR) agrees to participation by signing the informed consent form.

4.Patient with coronary artery disease undergoing percutaneous coronary intervention (PCI) with Eternia Everolimus Eluting Coronary Stent System only.

Exclusion Criteria

1.Pregnant and lactating females.

2.Patient treated with any other stent for coronary artery disease within 1 week.

3.Patients with impaired renal functions having baseline serum creatinine >2.0mg/DL.

4.Patients with active bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage.

5.Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Everolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.

6.Patients with life expectancy of less than 12 months.

7.Participating in other clinical studies that may restrict the patient’s compliance with follow up for this study.

8.Any other condition or reason that in opinion of investigator may restrict patient’s participation or compliance or inability to complete the study.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite end point at 1 year follow-up indicated by the Device Oriented composite (DoCE) defined as Cardiac Death, target vessel Myocardial infarction, or clinically indicated target lesion revascularization.Timepoint: 1 Year

Secondary Outcome Measures