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. 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-AB Everolimus Eluting Coronary Stent System only. 5. Patient with coronary artery disease having one or more de novo stenosis lesion in native coronary artery with a visually estimated diameter stenosis �70%. 6. Patients with Reference vessel diameter of 2.0 to 4.50 mm. 7. Patients with lesion length � 52 mm.
Exclusion criteria
Exclusion criteria: 1. Female patients with known pregnancy or who are lactating. 2. Patients requiring staged procedure. 3. Known congestive heart failure NYHA IV or left ventricular ejection fraction LVEF less than 40 percent. 4. 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. 5. Current medical condition with a life expectancy of less than 12 months. 6. Acute Myocardial Infarction within 72 hours of Planned Index procedure. 7. Patient has current unstable arrhythmias. 8. Patients previously treated with PCI or CABG for any coronary artery lesion revascularization. 9. Patients with Chronic Total Occlusion in two or more vessels. 10. Patients with Ostial lesions within 5.0mm of vessel origin. 11. Patients with Bifurcation lesions that include a side branch greater than 2.0 mm diameter. 12. Unprotected Left Main Coronary Artery lesion. 13. Heavily calcified lesion and or calcified lesion which cannot be successfully predilated. 14. Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal function serum creatinine greater than 2.0mg/dl or 150 mol/L, peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 1 year of the index procedure. 15. Patients with platelet count less than 100.000 cells/cubic millimetre or greater than 700.000 cells/cubic millimetre or a WBC less than 3.000 cells/cubic millimetre.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite end point at 9 months follow-up indicated by Major Adverse Cardiac Events (MACE) defined as hierarchical incidence of Cardiovascular Death, Myocardial infarction or Target Vessel Revascularization.Timepoint: 270 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of DOCE ââ?¬Â¢ Cardiovascular Death ââ?¬Â¢ Myocardial infarction in the territory of Target vessel (TV-MI) and ââ?¬Â¢ Clinically driven target lesion revascularization (CD-TLR) Timepoint: 30 Days 180 Days 270 Days 365 Days;Incidence of POCE ââ?¬Â¢ All cause death ââ?¬Â¢ Any Stroke ââ?¬Â¢ Any myocardial infarction (includes non-target vessel territory) ââ?¬Â¢ Any revascularizationTimepoint: 30 Days 180 Days 270 Days 365 Days;Incidence of MACE ââ?¬Â¢ Cardiovascular death ââ?¬Â¢ Nonââ?¬â??fatal MI ââ?¬Â¢ Target Vessel RevascularizationTimepoint: 30 Days 180 Days 365 Days;Target vessel failure (TVF)Timepoint: 30 Days 180 Days 270 Days 365 Days;Non-Target Vessel related Myocardial InfarctionTimepoint: 30 Days 180 Days 270 Days 365 Days;Stent thrombosis as per a. Academic Research Consortium- 2 [ARC-2] Evidence definitions ââ?¬â?? Definite and probable b. As per latency - Acute, Subacute and lateTimepoint: a.30 Days 180 Days 270 Days 365 Days b. Acute (0-24 hours) Subacute (24 hours-30 days) late (30-365 days);Device success: ââ?¬Â¢Residual coronary stenosis less than 20 % ââ?¬Â¢Normal coronary flow and absence of coronary dissections greater than C ââ?¬Â¢Procedural and absence of PCI complications including periprocedural MI, coronary perforation, urgent CABG or death or revascularization within 3 days of Index procedureTimepoint: 3 days;Procedural success: ââ?¬Â¢ Residual Stenosis less than 20% ââ?¬Â¢ Acute Device Success as defined by Residual Stenosis 20% ââ?¬Â¢ Successful reperfusion of Target vessel region with TIMI Flow 2Timepoint: 3 days;QCA Endpoint ââ?¬Â¢ Late Lumen Loss ââ?¬Â¢ Angiographic binary restenosis ââ?¬Â¢ In-stent and in-segment minimum lumen diameter (MLD) and % diameter stenosis (DS)Timepoint: 270 days | — |
Countries
India
Contacts
Public ContactPriyadarshini Arambam
Medanta Hospital
Outcome results
None listed