Safety and Performance Evaluation of the Supralimus Grace Sirolimus-eluting Stents in an All-comers Patient Populatio

Not Applicable

Conditions: Health Condition 1: I209- Angina pectoris, unspecified

Registration Number: CTRI/2018/09/015739

Lead Sponsor: Investigator Initiated Study

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patient aged 18 years or older

2. Patient with symptomatic coronary artery disease

3. Patient with a clinical indication for percutaneous coronary intervention (PCI) and stenting of at least one coronary lesion, visually confirmed on coronary angiography

4. Only Supralimus Grace stent(s) is/are to be implanted into the coronary vasculature during the index procedure

5. Patient provides signed informed consent for data release

6. Patient willing to comply with protocol specified follow-up

Exclusion Criteria

1. Patient with cardiogenic shock

2. Patient who is pregnant or possibly pregnant

3. Patients has a known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, sirolimus or contrast media

4. Patient scheduled to undergo elective surgery within 12 months post-index PCI

5. Patient who is currently participating in a clinical study of another drug or medical device and in whom assessment of the primary endpoint of that study has not been completed or clinically interferes with the endpoints of this clinical study

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (MI) and clinically-driven target lesion revascularizationTimepoint: 12 months

Secondary Outcome Measures

Name	Time	Method
Procedural endpoints: <br/ ><br>Device success, lesion success, procedural successTimepoint: At the end of the index procedure;Safety and efficacy endpoints: <br/ ><br>1. Overall stent thrombosis <br/ ><br>2. All deaths (cardiovascular, non-cardiovascular and undetermined) <br/ ><br>3. Any myocardial infarction <br/ ><br>4. Any repeat revascularization (target lesion revascularization, target vessel revascularization, target vessel non-target lesion revascularization) <br/ ><br>5. Target Lesion Failure <br/ ><br>6. Target Vessel Failure; a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization <br/ ><br>Timepoint: In-hospital, 30 days, 6 months, 12 months