Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: BioMimeTM-Sirolimus Eluting Coronary Stent (Medical Device): BioMimeTM-Sirolimus Eluting Coronary Stent in obstructive coronary artery disease.
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patient is an acceptable candidate for PTCA , Stenting or Emergent CABG Symptomatic ischemic heart disease (CCS class 1-4, Braunwald class IB, IC, IIB, IIC, IIIB,IIIC) and/or objective evidence of myocardial ischemia. TIMI flow grade >=2. C.T.Oâ??s (chronic total occlusions) and bifurcation lesions may also be attempted. Target lesion stenosis is >50% and Target lesions are de novo Target lesion Target lesion located in a major epicardial coronary vessel with reference of >= 2.5 - Target lesion which can be covered by one stent, no overlapping allowed (lesion stent ratio of at least 1.5) The patient and /or his legal representative have been informed of the nature of the study and agree to its provision s and have provided a written informed consent.
Exclusion criteria
Exclusion criteria: Women of childbearing potential Impaired renal function (creatinine >2.0 mg/dl or 180 µ mol/l) Any patient who has a platelet count 700,000 cells/mm3, a WBC of Recipient of an organ (Heart, Kidney, Lung) transplant. History of CVA or TIA within the last 3 months. Patient with a concomitant disease having a life expectancy of less than 12 months. Known allergies or contraindications to mTOR inhibitor class of drugs (Sirolimus), Aspirin, Clopidogrel Bisulphate Any significant medical condition which in the investigators opinion may interfere with the patients optimal participation in the study such as an active infection or peptic ulcer or upper GI bleeding. Currently participating in an investigational drug or another device study, or subject to inclusion in another investigational drug or another device study during follow up. Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate, including thrombocytopenia, neutropenia or leucopenia Patients with Cardiogenic Shock. Angiographic Exclusion Criteria: Left main coronary artery disease with >=50% stenosis. Angiographic evidence of thrombus (thrombus larger than half the diameter of the vessel and /or requiring other adjunctive interventions such as Angiojet, Exciser, Thrombolysis etc.) Left Ventricular Ejection Fraction Saphenous Vein Graft Interventions (S.V.Gâ??s) Patients presenting with an ongoing Acute Myocardial Infarction (AMI) Patients having undergone a PCI within 48 hours of an AMI episode.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective of the study is to study the difference in MACE rate at 30 days (safety outcome ) and In-Stent and In-Segment Late Loss (efficacy outcome by Core Lab QCA) at 8 months angiographic follow-up.Timepoint: MACE until 12 months Device related SAEâ??s until 12 months Angiographic stent thrombosis (%): acute (in-house), Sub acute (after procedure until 30 days) and Late (after 30 days until 12 months) Additional Clinical follow-up will be maintained at 1,3and 5 years for all patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary efficacy endpoints will be as follows: Quantitative Coronary Angiography derived vessel parameters in-stent and 5 mm proximal and 5mm distal from the edge of the stent: Acute gain, MLD(mm) Diameter Stenosis (%) LateLoss (mm) Binary Restenosis (%) In â??stent MLD pre-, post and 8 month follow up. Clinically Justified TLR (%) at 12 month. Timepoint: MACE until 12 months Device related SAEâ??s until 12 months Angiographic stent thrombosis (%): acute (in-house), Sub acute (after procedure until 30 days) and Late (after 30 days until 12 months) Additional Clinical follow-up will be maintained at 1,3and 5 years for all patients. | — |
Countries
India
Contacts
Public ContactDr Ashok Thakkar
Fortis Escorts Heart Institute
Outcome results
None listed