Evaluation of the Tetrilimus EVERolimus -eluting Coronary Stent by Optical Coherence Tomography

Not Applicable

Completed

• Conditions: Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere

• Registration Number: CTRI/2017/03/008032
• Lead Sponsor: Academics and Research Department Batra Hospital and Medical Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-08-14
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 57

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of covered struts <br/ ><br>Thickness of neointimal hyperplasia (NIH) over covered struts <br/ ><br>Proportion of malapposed struts <br/ ><br>Mean malapposed strut-to-lumen distance <br/ ><br>Ratio of uncovered struts to total struts (RUTTS) <br/ ><br>Maximum length of consecutive segments of uncovered and malapposed struts�Cross-section level analysis <br/ ><br>oNIH area, volume <br/ ><br>oPercent volumetric stent obstruction <br/ ><br>oIncomplete stent apposition (ISA) area and volume <br/ ><br> <br/ ><br>Timepoint: 3 month and 6 month

Secondary Outcome Measures

Name	Time	Method
At Post-procedure <br/ ><br>Mean and minimum stent area and volume <br/ ><br>Stent expansion, eccentricity and symmetry <br/ ><br>Mean and minimum lumen area and volume <br/ ><br>ISA area and volume <br/ ><br>Proportion of malapposed struts, mean malapposed strut-to-lumen distance <br/ ><br>Maximum length of consecutive segments of ISA <br/ ><br>Timepoint: At 3 and 6 months follow-up <br/ ><br>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 <br/ ><br>Quantification of NIH backscattering, attenuation and optical intensity <br/ ><br>