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CTRI Number  CTRI/2025/07/090233 [Registered on: 04/07/2025] Trial Registered Prospectively
Last Modified On: 04/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing effectiveness and efficiency of using a single device vs two devices for treating blockages in coronary arteries 
Scientific Title of Study   Fluoroscopy-to-device time Assessment of a Single, Universal Catheter vs Two Catheters for Efficient Reperfusion during Percutaneous Coronary Intervention (FASTER-PCI): A Prospective, Multi-Center, Randomized Controlled Trial 
Trial Acronym  FASTER-PCI 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nagendra Boopathy Seguttuvan 
Designation  Professor of Cardiology 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  B1 Room 5, Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research, No 1 Ramachandra Nagar, Porur, Chennai

Chennai
TAMIL NADU
600116
India 
Phone  7358560284  
Fax    
Email  drsnboopathy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nagendra Boopathy Seguttuvan 
Designation  Professor of Cardiology 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  B1 room 5, Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research, No 1 Ramachandra Nagar, Porur, Chennai

Chennai
TAMIL NADU
600116
India 
Phone  7358560284  
Fax    
Email  drsnboopathy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Meena Iyer 
Designation  Clinical Research Consultant 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Department of Clinical Research, SRDC Building Basement, Sri Ramachandra Institute of Higher Education and Research, No 1 Ramachandra Nagar, Porur, Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9841330590  
Fax    
Email  srmcclinicalresearch@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research, 1 Ramachandra Nagar, Porur, Chennai 600116 
TERUMO CORPORATION JAPAN 2-chOme-44-1 Hatagaya, Shibuya, Tokyo 151-0072, Japan 
 
Primary Sponsor  
Name  Terumo Corporation 
Address  Tokyo, Japan 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohajit Arneja  Arneja Heart & Multispeciality Hospital  Director: Cath lab, Department of Cardiology, Arneja Heart & Multispeciality Hospital, 123, Ramdaspeth, Behind Somalwar High School, Nagpur, 440010, India
Nagpur
MAHARASHTRA 
9923404261

arnejamohajit@gmail.com 
Dr Salman Salahuddin  Aster Malabar Institute of Medical Sciences  Room 1, Department of Cardiology, Aster MIMS, Mini Bypass Rd, Govindapuram, Kozhikode, Kerala, 673016, India
Kozhikode
KERALA 
9961553414

drsalmans@gmail.com 
Dr Sundar Chidambaram  Kauvery Hospitals  Department of Cardiology,225A, 23/1, Arcot Road, Vadapalani, Chennai, Tamil Nadu – 600026, India
Chennai
TAMIL NADU 
9444185058

sundarsaivimal@gmail.com 
Dr R H Sundar  Madras Heart Centre, Hariharan Diabetes and Heart Care Hospital  Department of Cardiology,24&26, NCBS Colony, Nanganallur, Chennai, Tamil Nadu – 600061, India
Chennai
TAMIL NADU 
9840793090

lathasundar07@gmail.com 
Dr Nagendra Boopathy Senguttuvan  Sri Ramachandra Institute of Higher Education and Research  B1 Room 5, Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research, No 1 Ramachandra Nagar, Porur, Chennai, 600116
Chennai
TAMIL NADU 
7358560284

drsnboopathy@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Arneja Heart & Multispeciality Hospital  Approved 
Kauvery Ethics Committee  Approved 
MIMS Institutional Ethics Committee  Approved 
SRIHER IEC  Approved 
SUBHAM ETHICS COMMITTEE  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I213||ST elevation (STEMI) myocardial infarction of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Judkins Two-Catheter system  In the conventional two-catheter strategy (Judkins Right, Judkins Left), patients will undergo coronary angiography using a diagnostic catheter and subsequent percutaneous coronary intervention (PCI) by a guiding catheter. Duration- only during PCI procedure (day 0) 
Intervention  Single Universal Catheter - Ikari Left  In the intervention group, patients will undergo both angiography and percutaneous coronary intervention (PCI) using a single, universal Ikari Left catheter. Duration- only during PCI procedure (day 0) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  a) Patients above 18 years of age who arrived at the emergency room within 24 hours of STEMI onset

b) Patients who are able to provide written, informed consent to the PCI procedure 
 
ExclusionCriteria 
Details  Patients with the following characteristics will be excluded:

a) Non-palpable radial pulse;

b) Temporary pacemaker placement before PCI;

c) Arteriovenous fistula in the right thoracic limb;

d) Presence of ascending thoracic aortic aneurysm;

e) Patients who underwent an interventional procedure other than PCI;

f) Patients with bifurcation lesions, which may require more specialized catheter approaches not suitable for a two-catheter or universal catheter strategy or 7-F systems;

g) Coronary artery anomalies that may require specific access techniques beyond the scope of the study;

h) Severe coronary tortuosity or stenosis at the takeoff of the coronary arteries that makes successful catheter engagement impossible or unsafe.

g) Patients in whom the lesions are not amenable for PCI and require surgical options such as coronary artery bypass graft (CABG);

h) Patients with failed radial access 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study is the difference of the fluoroscopy to device (FluTD) time between the single, universal Ikari Left guiding catheter strategy versus the conventional two catheter strategy. FluTD is defined as the time from the initial guide catheter or diagnostic catheter visualisation in ascending aorta to the time of device entry into the culprit coronary artery. Measured at the time of PCI procedure immediately after randomization  The primary outcome is a time metric measured when patients undergo the index angiography and PCI procedure, following onset and diagnosis of STEMI. As such, the primary outcome measure does not have follow-up timepoints and will be measured at a single instance during the procedure. The FluTD time measured during the procedure will be documented in fluoroscopy logs for subsequent analysis.

Primary outcome will be assessed at baseline (day 0) only, since it is a procedure timing. 
 
Secondary Outcome  
Outcome  TimePoints 
Assessing the impact of reduced FluTD time on left ventricular (LV) function, as measured by GLS using echocardiogram.   24 hours post-pCI, 3 months post-PCI  
Evaluating impact of reduced FluTD time on overall myocardial function by quantifying scar burden, ischemic burden, and degree of coronary microvascular obstruction using cardiac magnetic resonance imaging.   3-months post-PCI  
Proportion of Major Adverse Cardiovascular Events (MACE) including death, myocardial infarction, stroke, or revascularization of target vessel.  30 days post-PCI 
Procedural success rate, which is defined as the successful completion of index PCI procedure without any significant complications including conversion to surgery, failure to achieve revascularization or target vessel patency, bleeding events, and/or any device related complications.   Peri-procedure and post-procedure (until the duration of patient stay in the hospital)  
 
Target Sample Size   Total Sample Size="176"
Sample Size from India="176" 
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)   01/08/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Timely reperfusion remains the cornerstone of effective management in STEMI, with delays in revascularization directly correlating with increased morbidity and mortality. While system-level optimizations have reduced D2B times, procedural inefficiencies within the catheterization laboratory continue to be an underappreciated contributor to total ischemic time. The FASTER-PCI trial aims to address this gap by evaluating whether the procedural efficiency of the Ikari guiding catheter can meaningfully reduce intraprocedural delays, and thereby exert measurable impacts on clinical outcomes.

Our previous retrospective analysis demonstrated that the use of a single, universal Ikari Left (IL) guiding catheter significantly reduced Fluoroscopy-to-Device (FluTD) time compared to the conventional two-catheter strategy (Unpublished Data, 2025). Specifically, the IL catheter achieved a median FluTD time of 3 minutes versus 10 minutes with the conventional approach, without compromising procedural safety or efficacy. Patients in the Ikari group also exhibited superior myocardial perfusion, as evidenced by higher rates of myocardial blush grade 3 (Unpublished Data, 2025). These findings suggest that procedural modifications, such as catheter selection, have the potential to yield tangible improvements in reperfusion metrics, particularly in resource-constrained settings where system delays are pronounced. Further, quantifying the degree of improvement in left ventricular (LV) function as a direct result of reduced time to intervention of the culprit vessel has not been investigated previously.

The FASTER-PCI trial builds on these preliminary observations through a prospective, randomized controlled design to rigorously assess the impact of the Ikari catheter on both procedural efficiency and clinical outcomes. By incorporating endpoints such as GLS and LVEF at 24h and 3 months post-PCI, alongside traditional metrics such as D2B time and major adverse cardiac events (MACE), the proposed trial seeks to establish a comprehensive understanding of how procedural efficiency translates into long-term patient outcomes. Within this context, the introduction of the first FluTD time provides a granular lens through which to evaluate procedural delays, distinct from system-related variables that traditionally confound analyses of D2B times. However, several limitations warrant consideration. The retrospective analysis that informed this study was limited by its observational design and potential confounding factors. This trial is designed to overcome previous limitations through randomization, the inclusion of multiple study centers, and thorough data collection to examine differences in clinical outcomes. However, the ability to apply these findings broadly may be influenced by variations in operator experience with the Ikari catheter across different institutions and healthcare systems. 

Should the FASTER-PCI trial confirm the superiority of the Ikari catheter in reducing procedural delays and improve clinical outcomes without compromising safety, it could prompt a paradigm shift in STEMI management protocols. This is of paramount importance in low and middle income countries (LMICs) where procedural delays still exist and need to be minimized, in parallel with other efforts to reduce pre-hospital and other in-hospital delays. The adoption of a single, universal guiding catheter strategy may reduce intraprocedural delays and could contribute to improved myocardial salvage and long-term cardiac function, underscoring the importance of procedural efficiency as a modifiable determinant of STEMI outcomes.

 
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