| 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
|
|
|
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
|
|
|
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. |