Health Condition 1: null- Patient is an acceptable candidate for PTCA, Stenting, or Emergent CABG with Symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia.
Conditions
Interventions
Intervention1: MSure-S, Sirolimus Eluting Cobalt Chromium Stent system.: Patients will receive the Sirolimus eluting stents in sizes of 8, 12, 16, 20, 24, 28, 32, 36, 40 mm lengths, and diameters of 2
Sponsors
Multimedics
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient must be ï?³ 18 years of age; 2. Patient is an acceptable candidate for PTCA, Stenting, or Emergent CABG; 3. Symptomatic ischemic heart disease (CCS class 1 â??4 , Braunwald class IB, IC, IIB, IIC, IIIB,IIIC) and/or objective evidence of myocardial ischemia; 4. C.T.Oâ??s (Chronic Total Occlusions) and Bifurcation Lesions may also be attempted; 5. Target lesion stenosis is >50% and 6. Target lesions are de novo; 7. Target lesions 8. Target lesion located in a major epicardial coronary vessel with reference of >2.5 - 9. Target lesions which can be covered by one stent, no overlapping allowed (lesion stent ratio of at least 1.5)
Exclusion criteria
Exclusion criteria: Women of childbearing potential; 2. Impaired renal function (creatinine > 2.0 mg/dl or 180 µmol/l); 3. Any patient who has a platelet count 700,000 cells/mm3, a WBC of Laboratory evidence of Hepatitis; 4. Recipient of an organ (Heart, Kidney, Lung or Liver) transplant; 5. History of CVA or TIA within the last 3 months; 6. Patient with a concomitant disease having a life expectancy of less than 12 months; 7. Known allergies or contraindication to mTOR inhibitor class of drugs (Sirolimus), Aspirin, Clopidogrel Bisulphate (Plavixï??), Heparin, Cobalt Chromium/Nickel, contrast media; 8. Any significant medical condition which in the investigatorâ??s opinion may interfere with the patientâ??s optimal participation in the Registry such as an active infection or peptic ulcer or upper GI bleeding; 9. Currently participating in an investigational drug or another device Registry, or subject to inclusion in another investigational drug or another device Registry during follow- up. 10. Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate, including thrombocytopenia, neutropenia, or leukopenia 11. Patients with Cardiogenic Shock.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint of the Registry is defined as Major Adverse Cardiac Events (MACE) at 30 days, defined as a composite of Death, MI (both Q-wave and Non Q-wave MI), Emergent CABG, or clinically driven TLR (repeat PCI or CABG) and measured percentage wise. The primary effectiveness endpoint is the In-Stent and In-Segment Late Loss at 6-month follow-up determined by off-line Quantitative Coronary Angiography at a Core Lab.Timepoint: 1 month and 6 month respectively | — |
Secondary
| Measure | Time frame |
|---|---|
| MACE (%) until 12 months, Device related SAEs until 12 months, Angiographic Stent Thrombosis(%): Acute (In-Hospital), Subacute (post procedure until 30 days) and Late (after 30 days until 12 months). Angiographic/Device Success (%), Procedural Success (%), Quantitative Coronary Angiography derived vessel parameters.Timepoint: 6 to 12 months | — |
Countries
India
Contacts
Public ContactDr Sunil Thanvi
B&M Patel cardiac center
Outcome results
None listed