An Optical Coherence Tomography Study of Sirolimus-eluting Stent in Patients with Diabetes Mellitus

Not Applicable

• Conditions: Health Condition 1: I209- Angina pectoris, unspecified

• Registration Number: CTRI/2019/05/019297
• Lead Sponsor: niversal Cardiovascular Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

1. ST-segment elevation myocardial infarction within 7 days prior to the index procedure

2. Life expectancy <12 months due to another medical condition

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 <=3 months post-index 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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Strut-level analysis: <br/ ><br>1. Proportion of covered struts <br/ ><br>2. Thickness of neointimal hyperplasia (NIH) over covered struts <br/ ><br>3. Proportion of malapposed struts <br/ ><br>4. Mean malapposed strut-to-lumen distance <br/ ><br>5. Ratio of uncovered struts to total struts (RUTTS) <br/ ><br>6. Maximum length of consecutive segments of uncovered and malapposed struts <br/ ><br> <br/ ><br>Cross-section level analysis: <br/ ><br>1. NIH area, volume <br/ ><br>2. Percent volumetric stent obstruction <br/ ><br>3. Incomplete stent apposition (ISA) area and volumeTimepoint: 3 Months

Secondary Outcome Measures

Name	Time	Method
Qualitative NIH assessment at follow-up: <br/ ><br>- Proportion of cross-sections with peri-strut low intensity areas (PLIA) and neoatherosclerosis <br/ ><br>- 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