Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Dr Praveen Chandra
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patient with age > 18 Years 2. Patients with coronary artery disease undergoing percutaneous coronary intervention(PCI) with ISAR Summit Polymer Free Everolimus Eluting Coronary Stent System 3. Patients or legal guardian who understands the study requirements and can provide informed consent in writing
Exclusion criteria
Exclusion criteria: 1. Concurrent participation in another clinical trial that involves an investigational drug or device 2. Participant is pregnant or nursing an infant or child or planning to come pregnant while in the study 3. Concurrent medical condition with a life expectancy of less than 12 months 4. Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel or ticagrelor, Everolimus or similar drugs,or any other analogue or derivative, cobalt, chromium or contrast media
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiac Death Target Vessel failure related Myocardial Infarction (TV- MI) Clinically driven Target Lesion Revascularization (TLR) Timepoint: 1 Year | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient oriented composite (PoCE) defined as the composite of all- cause death, any MI, any stroke and any Revascularization) Cardiac Death Target Vessel failure related Myocardial Infarction (TV- MI) Clinically driven Target Lesion Revascularization (TLR) Definite/Probable Stent Thrombosis (defined by Academic Consortium (ARC) criteria Procedural Endpoints Device success Residual coronary stenosis 50%, normal coronary flow and absence of coronary dissection Timepoint: 30 days, 180 days, and 1 year post-index procedure | — |
Countries
India
Contacts
Public ContactPriyadarshini Arambam
Medanta-The Medicity
Outcome results
None listed