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CTRI Number  CTRI/2026/01/100907 [Registered on: 12/01/2026] Trial Registered Prospectively
Last Modified On: 12/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study Using Special Heart Imaging to See How Artery Blockages Affect Artery Shape After Stent Placement 
Scientific Title of Study   Impact of Plaque Eccentricity on Post-Stenting Vessel Geometry Assessed by Intravascular Ultrasound in Patients Undergoing Percutaneous Coronary Intervention 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rachepalli Sandesh Kumar Reddy 
Designation  Senior Resident 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Cardiology Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  7892101392  
Fax    
Email  rachepallisandesh05@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Padmakumar R 
Designation  Professor and HOD 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Cardiology Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9900921428  
Fax    
Email  padmakumar69@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Padmakumar R 
Designation  Professor and HOD 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Cardiology Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9900921428  
Fax    
Email  padmakumar69@yahoo.co.in  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospital Tiger Circle Road Madhav Nagar Manipal Karnataka- 576104  
 
Primary Sponsor  
Name  Kasturba Medical College and Hospital 
Address  Tiger Circle Road Madhav Nagar Manipal Karnataka- 576104 Karnataka- 576104 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Sandesh Kumar Reddy  Kasturba Medical College and Hospital  OPD Room no 37 Department of Cardiology Madhava pai OPD Block
Udupi
KARNATAKA 
7892101392

rachepallisandesh05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Instituitional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I20-I25||Ischemic heart diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Age greater than 18 years .
Undergoing PCI with planned IVUS guidance for a native coronary lesion with eccentric plaque de novo.
Undergoing PCI in ACS Settings with eccentric plaque.
Lesions with analyzable pre-intervention and post-deployment IVUS pullbacks motorized, standardized settings.
Provision of informed consent.
 
 
ExclusionCriteria 
Details  In-stent restenosis, bypass graft lesions.
Chronic total occlusions requiring subintimal tracking poor IVUS standardization. Hemodynamic instability precluding standardized imaging.
Inadequate IVUS image quality severe artefact, loss of EEL visualization on either pre- or post-stent run.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Post-stent stent eccentricity index (SEI) at MLA site (continuous).  At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
-Minimum stent area (MSA, mm²).
- Stent expansion (% relative to average of proximal & distal reference areas).
- Acute malapposition (presence/absence; extent in mm).  
At Baseline 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Coronary plaque morphology influences stent deployment mechanics. Eccentric plaque, often co localized with calcification, can resist uniform expansion, leading to asymmetric stent geometry and malapposition, both linked to adverse outcomes. IVUS provides high-resolution cross-sectional visualization, enabling quantification of plaque burden, distribution, and luminal/stent geometry. While IVUS-guided PCI improves achievement of larger MSA and reduces adverse events compared with angiography-guided strategies, the specific role of pre-stent plaque eccentricity as a predictor of post stent eccentricity is less well established in prospective real-world Indian cohorts. Some prior studies have reported correlations between calcific arcs, eccentric burden, and under-expansion; however, definitions of eccentricity and thresholds vary, and many analyses are post-hoc or limited by small samples and heterogeneous methodologies. A focused, prospective core-lab study using standardized IVUS definitions and motorized pullbacks can address these gaps. By adjusting for confounders (vessel size, lesion length, calcification severity, stent sizing, and post-dilatation), this study aims to isolate the independent contribution of plaque eccentricity to stent symmetry. The findings could inform lesion preparation (atherectomy or specialty balloons in highly eccentric, calcific plaques), refine stent sizing, and establish pragmatic imaging-based algorithms to target symmetric expansion and adequate MSA.

 
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