To evaluate safety and performance of the Evermine 50-50μm Everolimus-Eluting Coronary Stent System (EES) in the treatment of patients with de novo native coronary artery lesions.

Phase 4

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

• Registration Number: CTRI/2017/03/008173
• Lead Sponsor: Meril Life Sciences Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

1.The subject must be at least 18 years of age at the time of signing the informed consent.

2.The subjectâ??s legally authorized representative agrees to the subjectâ??s participation in this study and signs the informed consent form.

3.The subject who agree to participate in the study.

4.Only Evermine 50 EES stent(s) is (are) implanted during the index procedure.

5.The subject whose coronary artery is suitable for implantation of Evermine 50 EES.

6.Female subjectâ??s of childbearing potential who does not plan pregnancy for up to 2 years from the date of index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results at screening visit.

7.Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 2 years from the date of index procedure.

8.Subject agrees not to participate in any other investigational or invasive clinical study for a period of 2 years from the date of index procedure

Exclusion Criteria

1.The inability to obtain an informed consent.

2.Subject with known hypersensitivity or allergies to aspirin, heparin, Everolimus, polymer lactide, Cobalt-chromium metal and glycolide antiplatelet drugs (clopidogrel, prasugrel etc).

3.Female subject with known pregnancy or who are lactating at the time of screening

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE), Ischemic Driven Target Lesion Revascularization(ID-TLR) <br/ ><br>Timepoint: 1 month (±14 days), 6 months (±28days), <br/ ><br>12 months (±28 days) and 24 months (±28 days) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Ischemic Driven Target Vessel Revascularization (ID-TVR), <br/ ><br>Procedural success, <br/ ><br>Device SuccessTimepoint: 1 month (±14 days), 6 months (±28 days), <br/ ><br>12 months (±28 days) and 24 months (±28 days) <br/ ><br>