| CTRI Number |
CTRI/2025/10/096215 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying outcomes of Calcium modifying device in Severely Calcified Coronary Arteries Under guidance of Imaging |
|
Scientific Title of Study
|
Prospective, Multicenter, Observational Study to Evaluate Clinical Outcomes of Orbital Atherectomy in Severely Calcified Coronary Arteries Under OCT Guidance |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SOAR TVF/2025_V 1.0_30 Apr 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Balbir Singh |
| Designation |
Group Chairman - Cardiac Sciences |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Department of Cardiology,
Room No.6,
East Block,
Max Super Speciality Hospital,
(A unit of Devki Devi Foundation)
2, Press Enclave Road, Saket
New Delhi DELHI 110017 India |
| Phone |
9818890479 |
| Fax |
|
| Email |
drbalbirs@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Balbir Singh |
| Designation |
Group Chairman - Cardiac Sciences |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Department of Cardiology,
Room No.6,
East Block,
Max Super Speciality Hospital,
(A unit of Devki Devi Foundation)
2, Press Enclave Road, Saket
New Delhi DELHI 110017 India |
| Phone |
9818890479 |
| Fax |
|
| Email |
drbalbirs@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Balbir Singh |
| Designation |
Group Chairman - Cardiac Sciences |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Department of Cardiology,
Room No.6,
East Block,
Max Super Speciality Hospital,
(A unit of Devki Devi Foundation)
2, Press Enclave Road, Saket
New Delhi DELHI 110017 India |
| Phone |
9818890479 |
| Fax |
|
| Email |
drbalbirs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Pvt Ltd, Office Floor, The Suryaa Hotel. New Friends Colony. New Delhi 110 025 India |
|
|
Primary Sponsor
|
| Name |
Dr Balbir Singh (Max Super Speciality Hospital) |
| Address |
Group Chairman - Cardiac Sciences, Pan Max & Chief of Interventional Cardiology and Electrophysiology
Max Super Speciality Hospital, Saket, New Delhi
|
| Type of Sponsor |
Other [Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajib Lochan Bhanja |
Arpa Medcity Hospital and Research Institute |
Department of Cardiology, Cath lab,3rd floor, Room No.1,Near SBI Commercial Branch, Vyapar Vihar,Bilaspur Chhattsigarh-495001 Bilaspur CHHATTISGARH |
7752446322
drrajiev@gmail.com |
| Dr Subhash Chandra |
Dr.B.L.Kapur Memorial Hospital (Unit of Lahore Hospital Society) |
Department interventional cardiology,Room No.197,1st floor, OPD 6 BLK-Max Super Speciality Hospital,Pusa Road New Delhi-110005 Central DELHI |
9810075983
subhash.chandra@blkhospital.com |
| Dr Makhale Chandrashekhar Narayan |
Grant Medical Foundation Ruby Hall clinic |
Department of cardiology,2nd floor Cathlab, Main Building 40,Sassoon Road,Pune-411001,Maharashtra Pune MAHARASHTRA |
98220 30130
cnmakhale@gmail.com |
| Dr Chadha Davinder Singh |
Manipal Hospitals |
Department of Cardiology, Room No.06,1st floor, No 98,Old Airport Road, Bengaluru 560017 Bangalore KARNATAKA |
8390963737
drdschadha@gmail.com |
| Dr Balbir Singh |
Max Super Speciality Hospital |
Department of Cardiology,
Room No.6,
East Block,
(A unit of Devki Devi Foundation)
2, Press Enclave Road, Saket, New Delhi, Delhi 110017 New Delhi DELHI |
9818890479
drbalbirs@gmail.com |
| Dr Sivakumar Rathnavel |
Meenakshi Super Speciality Hospital |
Ground floor Room No.1, 171 Lake Area Melur Road, Uthangudi, Madurai-625107 Madurai TAMIL NADU |
9842158870
drsivakumar2004@gmail.com |
| Dr Chirag Jagdish Parikh |
SMT SR Mehta Sir K P Cardiac Insititute |
Cath lab Department,2nd floor, Plot No.96, Rd No.31, Near Gandhi Market, Kings Circle,Sion East,Mumbai-400022 Mumbai MAHARASHTRA |
9819760153
parikhcj@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| ACE Indepedent Ethics Committee |
Approved |
| Ethics Committee of Manipal Hospitals |
Submittted/Under Review |
| IEC AARCE DR.B.L.KAPUR MEMORIAL HOSPITAL |
Approved |
| Institutional Ethics Committee Max Super Speciality Hospital |
Approved |
| Institutional Ethics Committee Meenakshi Mission Hospital and Research Centre |
Approved |
| Poona Medical Research Foundation Ruby Hall Clinic |
Approved |
| Vedant Hospital Institutional Ethics Commitee Tieten Medicity Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I25||Chronic ischemic heart disease, (2) ICD-10 Condition: I214||Non-ST elevation (NSTEMI) myocardial infarction, (3) ICD-10 Condition: I200||Unstable angina, |
|
|
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 |
1. Patients of either gender, aged 18 years and above
2. Patients presenting with any one of the conditions (SIHD/US/NSTEMI)
3. Patients willing to sign written informed consent
Imaging Inclusion Criteria
1. Use of OCT guidance mandatory for all enrolled patients
2. The target lesion(s) is a de novo coronary lesion with stenosis more than equal to 50% and less than 100%, the reference vessel diameter of each target vessel more than or equal to 2.5 and less than 4.0mm at the lesion site
3. The target lesion has OCT evidence of severe calcium at the lesion site |
|
| ExclusionCriteria |
| Details |
1. Patients with hemodynamic instability or cardiogenic shock
2. Patients with chronic total occlusion and In-stent restenosis lesions
3. Patients with a life expectancy of less than 1 year
4. Patients with contraindication for dual antiplatelet therapy (DAPT)
5. Patients who require the use of atherectomy devices, laser, or intravascular lithotripsy (IVL) other than OA in the target lesion
6. Patients unwilling to sign the informed consent
Angiographic Exclusion criteria
1. The target lesion is located within a bypass graft
2. Angiographic evidence of thrombus
3. Angiographic evidence of significant dissection at the treatment site
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of Target vessel failure (TVF) defined as a composite of Target vessel myocardial infarction (TV-MI), Cardiovascular death and Target lesion revascularization (TLR) |
One Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Procedural Success
2. Clinical Success
3. MACE |
1. Baseline
2. Baseline
3. In-hospital, 30 days, 6 & 12 months
|
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
31/10/2025 |
| 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="2" Months="0" 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 artery disease (CAD) remains a major contributor to
cardiovascular morbidity and mortality worldwide, forming a substantial portion
of the global burden of cardiovascular diseases (CVD). In 2019,
CVDs accounted for 33% of all global deaths, with ischemic heart disease and
stroke being major contributors. In
India, the prevalence of CAD is estimated at 10.5%, exceeding the global
average and indicating a higher disease burden.
Initially thought to be a passive degenerative process, coronary artery
calcification (CAC) is commonly indicative of advanced atherosclerosis. CAC is
associated with decreased vascular compliance and increases the risk for
adverse cardiovascular events. It is an age-related condition that
typically begins to manifest after the age of 40 and is most prevalent in men
over the age of 70. Risk
factors such as diabetes, chronic kidney disease, hypertension, hyperlipidemia,
and smoking have all been shown to accelerate the development of calcified
lesions in the coronary arteries. These calcified plaques pose a
significant challenge during percutaneous coronary intervention (PCI), often
complicating stent delivery and expansion. In Indian patients, studies have
reported moderate to severe calcification in 11.6% to 17% of coronary lesions,
with nearly 80% falling under type B or type C classification, underscoring
the need for effective lesion preparation strategies.
Despite technological advancements in
interventional cardiology, treating heavily calcified lesions remains complex.
One promising approach is orbital atherectomy (OA), a technique that modifies
and debulks calcified plaques to facilitate successful stent deployment.
Approved by the US FDA in 2013, OA has been increasingly adopted for this
purpose and is currently recommended by the 2021 ACC/AHA/SCAI guidelines for
managing heavily calcified lesions during PCI.
Intravascular imaging has become an
invaluable intraprocedural tool in guiding PCI procedures, enabling detailed
assessment of extent, phenotype, and location of calcium in target coronary
arteries, enhancing optimal stent deployment and reducing adverse events.
Optical Coherence Tomography (OCT) is a high-resolution intravascular imaging modality that provides
detailed visualization of coronary artery structures, making it particularly
valuable in the assessment and management of complex, calcified, and tortuous
lesions. OCT enables precise evaluation of calcium characteristics—such as
thickness, arc, and length—as well as the degree of ablation within the intima
and media. This level of detail aids in optimal lesion preparation,
contributing to improved procedural outcomes.
Given the rising complexity of severely
calcified lesions and the need for improved procedural outcomes, exploring the
use of OA under OCT guidance could offer valuable insights into optimizing
treatment for these challenging cases. Combining OA with OCT could enhance
lesion preparation, improve stent deployment, and increase procedural success
rates.
This study aims to assess the clinical outcomes of
OA performed under OCT guidance for the treatment of severely calcified
coronary artery lesions over a one-year period. |