Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: BioMimeâ?¢ - Sirolimus Eluting stents: Treatment Of Patients with single, De-Novo, Coronary Artery Lesions. This device has the particularity to be covered by Sirolimus, in order to pre
Sponsors
Meril Life Sciences India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient is >18 years of age. 2. Patient is an acceptable candidate for PTCA, stenting, or emergent CABG 3. Patient has clinical evidence of ischemic heart disease or a positive functional study. 4. Patient with his or her treating physician agree that the patient will comply with all the required post-Procedure follow up 5. TIMI (Thrombolysis In Myocardial Infarction) Flow grade 2 6. Target Lesion(s) present with greater than or equal to 50% and 7. Target Lesion is de novo 8. A maximum of one (01) target lesion requires treatment 9. For a single lesion, a cumulative lesion length of up to 19mm is to be treated 10. Reference vessel diameter of target lesion(s) must be greater than or equal to 2.5mm and less than or equal to 3.5mm, by visual estimate. 11. Patient or the patientâ??s legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/ Ethics Committee of the respective clinical site.
Exclusion criteria
Exclusion criteria: 1. Left ventricular ejection fraction (LVEF) of less than or equal to 30% 2. Patient has evidence of an acute myocardial Infarction whose onset began within 48 hours of the intended treatment (defined as Creatinine Kinase (CK) >2x the upper limit of normal and CK-MB elevated) or CK or CK-MB remain elevated at the time of treatment 3. History of CVA or TIA within the last 3 months 4. Patient has active infection. 5. Concurrent medical conditions with a life expectancy of less than 12 months. 6. Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate including thrombocytopenia, neutropenia, or leukopenia. 7. Active peptic ulcer or upper gastrointestinal bleeding. 8. Current participation in an investigational drug or device trial that has not completed its primary end point follow-up period. 9. Pregnancy or woman of childbearing potential who, in the opinion of the investigator, does not take adequate measures to prevent conception. 10. Known hypersensitivity or contraindication to cobalt, chromium, or nickel. 11. Known sensitivity to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated. 12. History of an allergic reaction or significant sensitivity to drugs such as mTOR or any of its derivatives in the limus family of drugs. 13. Platelet count 700,000 cells/mm³ or known coagulopathy. 14. Serum creatinine >2.0 mg/dL or >180umol/L, renal failure, or liver disease. 15. The planned treatment requires a device (including non study drug-eluting stent) or procedure other than PTCA (eg, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy) 16. Previous brachytherapy anywhere in the target vessel 17. History of heart, liver, lung and kidney transplant. 18. Recipient of a Heart Transplant. 19. Target Vessel has evidence of thrombus or is excessively tortuous (2 bends >than 90° to reach the target lesion) 20. Evidence of unprotected left main coronary artery disease (an obstruction of 50% in the left main coronary artery). 21. Is the patient in Cardiogenic Shock? 22. Is it a Saphenous Vein Graft Intervention? 23. PCI during or within 48 hours of Acute Myocardial Infarction? 24. Significant stenosis ( >50%) proximal or distal to the target lesion that might require revascularization or impede runoff. 25. Prior CABG Surgery to Target Vessel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. In-Stent luminal loss assessed by quantitative coronary angiography (QCA) at 8 Month follows up. 2. Percentage of In-Stent Volume obstruction measured by IVUS at 8 Month follows upTimepoint: 1,8, 12, 24 Month follows up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of Major Adverse Cardiac Events (MACE) defined as cardiac death, nonfatal acute myocardial infarction, and need for repeat target-lesion revascularization (by cardiac bypass graft or repeat percutaneous coronary intervention up to 24 months of follow-up. â?¢ Angiographic binary restenosis at 8 months angiographic follow upTimepoint: 1,8, 12, 24 Month follows up | — |
Countries
India
Contacts
Public ContactDr Ashok Thakkar
Life Care Institute of Medical Science and Research
Outcome results
None listed