Health Condition 1: I209- Angina pectoris, unspecified
Conditions
Sponsors
Universal Cardiovascular Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient must be at least 18 years of age 2. Patient with symptomatic coronary artery disease 3. Stable patients with diabetes mellitus 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. ST-segment elevation myocardial infarction within 7 days prior to the index procedure 2. Life expectancy 3. Contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus or structurally related compounds 4. Creatinine level more than 2.0 mg/dL or ESRD 5. Severe hepatic dysfunction (more than 3 times normal reference values) 6. Planned surgery procedure 7. Known allergy to cobalt-chromium 8. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 3 months post index procedure 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