Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Innvolution Healthcare Private Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 9 Procedural success: device success & absence of PCI complications (periprocedural MI, coronary perforation, urgent CABG or death) or revascularization within 3 daysTimepoint: 3 days;Definite/probable stent thrombosis as per Academic Research Consortium [ARC] definitionsTimepoint: 30 days 180 days 270 days 1 Year;Device success : residual coronary stenosis less than 50% , normal coronary flow & absence of coronary dissections C, TIMI Flow 2Timepoint: 3 days;Endpoints for OCT groups : Diameter Stenosis % at 9 months, Proportions of in-stent & in-segment binary restenosis, Proportion of Struts uncovered and malposed, Area restenosis & Neo-intimal hyperplasiaTimepoint: 270 days;Endpoints for QCA groups: Late Lumen Loss at 9 months, % diameter stenosis (DS), Angiographic binary restenosis, In-stent & in-segment minimum lumen diameter (MLD)Timepoint: 270 days;Incidence of DOCE -Cardiac Death -Target vessel Myocardial infarction (TV-MI) and -Clinically driven target lesion revascularization (TLR). Timepoint: 30 days 180 days 270 days 1 Year;Incidence of MACE -CV death -Non–fatal MI -Non-fatal strokeTimepoint: 30 days 180 days 270 days 1 Year;Incidence of POCE -All cause death -Any myocardial infarction -Any revascularization Timepoint: 30 days 180 days 270 days 1 Year;Non -Target Vessel related Myocardial InfarctionTimepoint: 30 days 180 days 270 days 1 Year;Severe BARC bleeding 3Timepoint: 30 days 180 days 270 days 1 Year;Target vessel failure (TVF)Timepoint: 30 days 180 days 270 days 1 year | — |
Countries
India
Contacts
Public ContactPriyadarshini Arambam
Batra Hospital and Medical Research Centre
Outcome results
None listed