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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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