| 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
|
|
|
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
|
|
|
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. |