Health Condition 1: null- Coronary Artery Occlusion
Conditions
Sponsors
Dr M S Hiremath
Biosensors and Choksi Imaging Limited as collaborators
Eligibility
Inclusion criteria
Inclusion criteria: 1.Eligible and willing patient for percutaneous transluminal coronary angioplasty (PTCA) requiring stenting with Biolimus A9-Eluting Coronary Stent. 2. Informed and consented. 3. Patient agreeing to comply with protocol specified follow-up evaluations.
Exclusion criteria
Exclusion criteria: 1. Participating in investigational drug/device trial that has not completed primary endpoint or interferes with trial endpoints 2. Patients stented/deployed with additional stent which is not BES. 3. Known allergy to aspirin, clopidogrel, heparin, stainless steel, sirolimus, biolimus, contrast material 4. Renal Dysfunction (Creatinine > 3mg%) 5. Pregnancy 6. Elective surgery within 6 months of stent implantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study device oriented major adverse cardiac events (MACE) defined as Composite of cardiac death, myocardial infarction (Q-wave and Non-Qwave), or justified target vessel revascularization.Timepoint: at 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. MACE (Composite of cardiac death, myocardial infarction (Q-wave and Non-Q wave), or justified target vessel revascularization) ; 2. Stent thrombosis rate (As per Academic Research Consortium)Timepoint: at 1 and 12 months | — |
Countries
India
Contacts
Public ContactTushar Mhetre
Ruby Hall Clinic
Outcome results
None listed