Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere
Conditions
Interventions
Intervention1: Tetrilimusââ??¢: Tetrilimus is a combination product comprised of two components a device Tetrinium coronary stent system as a platform and a drug product a formulation of everolimus
Sponsors
Academics and Research Department Batra Hospital and Medical Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: Patient more than or equal to 18 years of age eligible for PCI LVEF of more than or equal to 40 percentage Up to 2 de novo lesions in separate coronary vessels visually estimated stenosis more than or equal to 50 percentage and 100 percentage with TIMI flow 1
Exclusion criteria
Exclusion criteria: Patient a history of hypersensitivity to everolimus Patient exhibits cardiogenic shock evidence of acute or chronic renal dysfunction Planned cardiac surgery procedure less than or equal to 6 months post index procedure Cerebrovascular accident including stroke or TIA within previous 3 months evidence of leukopenia evidence of currently on warfarin thrombocytopenia currently on warfarin Known allergy to cobalt chromium Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure acute myocardial infarction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of covered struts Thickness of neointimal hyperplasia (NIH) over covered struts Proportion of malapposed struts Mean malapposed strut-to-lumen distance Ratio of uncovered struts to total struts (RUTTS) Maximum length of consecutive segments of uncovered and malapposed strutsââ?¬Â¢ Cross-section level analysis o NIH area, volume o Percent volumetric stent obstruction o Incomplete stent apposition (ISA) area and volume Timepoint: 3 month and 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| At Post-procedure Mean and minimum stent area and volume Stent expansion, eccentricity and symmetry Mean and minimum lumen area and volume ISA area and volume Proportion of malapposed struts, mean malapposed strut-to-lumen distance Maximum length of consecutive segments of ISA Timepoint: At 3 and 6 months follow-up Serial changes in mean lumen area, minimum lumen area, and ISA area from post-procedure to the assigned follow-up period Qualitative NIH assessment at both follow-up periods Proportion of cross-sections with peri-strut low intensity areas (PLIA) and neoatherosclerosis Quantification of NIH backscattering, attenuation and optical intensity | — |
Countries
India
Contacts
Public ContactDr Upendra Kaul
Batra Hospital and Medical Research Centre
Outcome results
None listed