Health Condition 1: I213- ST elevation (STEMI) myocardial infarction of unspecified site
Conditions
Interventions
Intervention1: Not applicable: Not applicable
Sponsors
Universal Cardiovascular Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient must be at least 18 years of age 2. Acute Myocardial Infarction (MI) with ST-segment elevation, within 12 hours from symptoms onset 3. Native coronary artery disease with >70% diameter stenosis (no prior stent implant, no prior brachytherapy) 4. Only Supralimus Grace stent(s) is/are to be implanted into the coronary vasculature during the index procedure 5. Able to understand and sign the written informed consent form 6. Able and willing to follow the protocol requirements
Exclusion criteria
Exclusion criteria: 1. Lesions in coronary artery bypass grafts 2. Significant left main disease 3. Killip class IV 4. Recent major bleeding (6 months) 5. Renal failure with creatinine value >2.5 mg/dl 6. Contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus or structurally related compounds 7. Patient in anticoagulant therapy 8. Internal mammary artery (IMA) due to a stent thrombosis 9. No suitable anatomy for OCT scan in the opinion of investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Strut-level analysis: 1. Proportion of covered struts 2. Thickness of neointimal hyperplasia (NIH) over covered struts 3. Proportion of malapposed struts 4. Mean malapposed strut-to-lumen distance 5. Ratio of uncovered struts to total struts (RUTTS) 6. Maximum length of consecutive segments of uncovered and malapposed struts Cross-section level analysis 1. NIH area, volume 2. Percent volumetric stent obstruction 3. Incomplete stent apposition (ISA) area and volumeTimepoint: 3 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Qualitative NIH assessment at follow-up: - Proportion of cross-sections with peri-strut low intensity areas (PLIA) and neoatherosclerosis - Quantification of NIH backscattering, attenuation, and optical intensityTimepoint: 3 Months;Serial changes in mean lumen area, minimum lumen area, and ISA area from post-procedure to the assigned follow-up periodTimepoint: 3 Months | — |
Countries
India
Contacts
Public ContactDr Atul Abhyankar
Shree B. D. Mehta Mahavir Heart Institute
Outcome results
None listed