CTRI

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CTRI Number

CTRI/2025/07/092033 [Registered on: 30/07/2025] Trial Registered Prospectively

Last Modified On:

12/03/2026

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Follow Up Study

Study Design

Single Arm Study

Public Title of Study

A study to see the performance and safety of RisoR Crest Everolimus Eluting Coronary Stent System in patients with coronary artery disease

Scientific Title of Study

An OPen-label, Multicentre, Single Arm, Clinical InvestigatIon to Evaluate PerFormance and safety of RIsoR Crest EveRolimus Eluting Coronary Stent System

Trial Acronym

PACIFIER

Secondary IDs if Any

Secondary ID	Identifier
CSPL/REG/2025/02 V1.0 dated 23 Apr 2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Praveen Chandra
Designation	Chairman Interventional and Structural Heart Cardiology
Affiliation	Medanta-The Medicity
Address	Division of Interventional and Structural Cardiology, Sector 38 Gurgaon HARYANA 122001 India
Phone	9810125370
Fax
Email	praveen.chandra@medanta.org

Details of Contact Person
Scientific Query

Name	Dr Praveen Chandra
Designation	Chairman Interventional and Structural Heart Cardiology
Affiliation	Medanta-The Medicity
Address	Division of Interventional and Structural Cardiology Sector 38 Gurgaon HARYANA 122001 India
Phone	9810125370
Fax
Email	praveen.chandra@medanta.org

Details of Contact Person
Public Query

Name	Haobam Rakesh Singh
Designation	Project Manager
Affiliation	Clicebo Solutions Private Limited
Address	Room No.1, Clinical Operations Department, E-961, Lower Ground Floor, CR Park South DELHI 110019 India
Phone	8745878425
Fax
Email	pm@clicebo.com

Source of Monetary or Material Support

Poly Medicure Limited, 232B, 3rd Floor Okhla Industrial Estate, Phase-III, New Delhi-110020, India

Primary Sponsor

Name	Poly Medicure Limited
Address	232B, 3rd Floor Okhla Industrial Estate, Phase -III, New Delhi- 110020
Type of Sponsor	Other [Medical Device Manufacturing Company]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India
Italy

Sites of Study
Modification(s)

No of Sites = 37
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Rakendra Singh	Adesh Institute of Medical Science & Research	1st floor Adesh Cardiac Care Adesh University of Medical Science & Research. Bathinda PUNJAB	7790000001 dr.cardiology.adesh@gmail.com
Dr Rajesh Badani	Aditya Birla Memorial Hospital	Aditya Birla Hospital Marg Near Patangi Paper Mill Thergaon Chinchwad Pune-411033 Pune MAHARASHTRA	9823818400 drbadanirajesh21@gmail.com
Dr Anuj Amrit Kapadiya	Asian Institute of Gastroenterology Hospital	Survey No 136 Plot No 2/3/4/5 1 Mindspace Road Gachibowli Hyderabad Telangana- 500082 Hyderabad TELANGANA	9959977966 dranuj.kapadiya@aighospitals.com
Dr Kaustubh Subhash Machnurkar	Aster Aadhar Hospital	R.S No 628 ‘B’ Ward Near Shastri Nagar, KMT workshop, Kolhapur Kolhapur MAHARASHTRA	9552480833 drkaustubh.kcro@gmail.com
Dr Shailesh Jayade	Axon Hospital	Opposite Tahsil Office Near Prabhat Talkies Amravati-444601 Amravati MAHARASHTRA	9921266222 drshaileshj@gmail.com
Dr Upendra Kaul	Batra Hospital and Medical Research Centre	Batra Heart Centre, 1st Floor Room No. 17, 1, Tughlakabad Institutional Area, Mehrauli Badarpur Road, New Delhi-110062 New Delhi DELHI	9811150518 upendra.kaul@batrahospitaldelhi.org
Dr Pranav Baburao Shamraj	BKL Walawalkar Hospital Diagnostic & Research Centre	BKL Walawalkar Hospital Diagnostic & Research Centre Kasarwadi Post Sawarde Taluka- Chiplun District Ratnagiri Maharashtra-415606 Ratnagiri MAHARASHTRA	8999370401 drshamraj@gmail.com
Dr Pannala Lakshmi Narasimha Kabardy	CARE Hospitals	6-3-248/2 Road no 1 Banjara hills Hyderabad-500034 Hyderabad TELANGANA	9848047521 dr.kaparthi@gmail.com
Dr Manoj kumar Bhavarilal Chopada	Chopda Medicare & Research Centre Pvt Ltd.Magnum Heart lnstitute	3/5, Patil Lane No.1, Laxmi Nagar, Near K.B.H Vidyalaya, Canada Corner, Nashik-422005, Maharashtra, lndia Nashik MAHARASHTRA	9823021 613 drchopdamanoj@gmail.com
Dr Akash Batta	Dayanand Medical College & Hospital	Dayanand Medical College & Hospital Unit Hero DMC Heart Institute Tagore Nagar Ludhiana-141001 Punjab India Ludhiana PUNJAB	9815496786 akashbatta02@gmail.com
Dr Prashant Dwivedi	Eternal Hospital	3,A, Jagatpura Road, Near Jawahar Circle, Rajasthan, Jaipur-302017 Jaipur RAJASTHAN	8808005543 dr.prashantdwivedi@gmail.com
Dr Mayank Goyal	Frank Institute of Medical Sciences	Frank Institute of Medical Sciences Bahalgarh Sonipat Haryana-131001 Sonipat HARYANA	9911341725 drmayankgoyal@gmail.com
Dr Mallindra Swamy	Gleneagles AWARE Hospital	08-16-01,near sagar X Roads, Saroornagar L.b.nagar Hyderabad-500035 Hyderabad TELANGANA	9441888797 mallindraswamy@gmail.com
Dr Sai Sudhakar	Gleneagles Hospital	6-1-1070/1 to 4 , Lakdikapul Hyderabad-500004 Hyderabad TELANGANA	9000192233 sudhakar_doc@yahoo.com
Dr Himanshu Rana	Graphic Era Institute of Medical Science	16th Milestone Chakrata Road Dehradun 248008 Dehradun UTTARANCHAL	6238933662 himanshurana.geims@geu.ac.in
Dr Raj Pratap Singh	Graphic Era Institute of Medical Sciences	Fourth floor Cath lab 16th Milestone,Chakrata Road,Dehradun-248008 Dehradun UTTARANCHAL	9795004453 rajpratapsingh.geims@geu.ac.in
Dr Amitabh Yaduvanshi	Holy Family Hospital	Department of Cardiology Okhla Road New Delhi-110025 East DELHI	9810794959 amitabhy@gmail.com
Dr Pramod Kumar	Jay Prabha Medanta Super Speciality Hospital	Housing Board Colony Kankarbagh Patrakar Nagar Patna Bihar-800020 Patna BIHAR	9810123571 pramod.kumar1@medanta.org
Dr Suryakant Jena	Kalinga Institute of Medical Sciences	Kushabhadra Campus, 5, KIIT Road, Bhubaneshwar-751024 Baleshwar ORISSA	8098341692 suryakant.jena@kims.ac.in
Dr Aejaz Ahmed Shah	Kiran Health Care Center	Khemka Nagar Near Hospital Chowk Bajoria Road Saharanpur- 247001 Saharanpur UTTAR PRADESH	9622537083 ejazahmad8550@gmail.com
Dr Pushpendra Kumar Garg	Krishna Heart & General Hospital	138 Prem Niwas Pandit T N Mishra Marg Swami Vihar 153 Gopalpura Bypass Rd Santosh Nagar Shiv Shakti Nagar Brijlalpura Jaipur Rajasthan 302019 Jaipur RAJASTHAN	9887466966 drpushpendrakumarg@gmail.com
Dr Dheeraj Kumar Soni	Lala Lajpat Rai Memorial Medical College	Department of Cardiology, Jai Bhim Nagar, Garh Road, Meerut, Uttar Pradesh - 250004 Meerut UTTAR PRADESH	9971406334 drsonidheeraj@gmail.com
Dr Santosh Kumar Sinha	LPS Institute of Cardiology & Cardiac Surgery	Room No. 13 3rd Floor GT Road Rawatpur Kanpur-208002 Uttar Pradesh India Kanpur Nagar UTTAR PRADESH	9670220088 fionasan@rediffmail.com
Dr Abhijit Bhaskar Joshi	Manipal Hospitals	Sr No 111/11/1 Mahalunge Baner Road Opp D Mart Baner Pune Maharashtra-411045 India Pune MAHARASHTRA	9823074846 drabhijeetjoshi@yahoo.com
Dr Sabyasachi Mukhopadhyay	Manipal Hospitals Goa	DR E Borges Road Dona Paula Panaji 403004 North Goa GOA	8698861561 msabyasachi@yahoo.com
Dr Praveen Chandra	Medanta-The Medicity	Department of Cardiology, Sec-38, Gurugram, Haryana-122001 Gurgaon HARYANA	9810125370 praveen.chandra@medanta.org
Dr Rajneesh Kapoor	Medanta-The Medicity	Department of Cardiology & Structural Heart, Sec-38, Gurugram, Haryana-122001 Gurgaon HARYANA	9971991740 rajneesh.kapoor@medanta.org
Dr Hitendra Bhagwatkar	NKP Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital	Department of Cardiology, Digdoh Hills,Hingna Road,Nagpur-440019 Nagpur MAHARASHTRA Nagpur MAHARASHTRA	9096115922 hitendrabhagwatkar@gmail.com
Dr Gajendra Agarwal	Orbit Multispeciality Hospital	806 Bhande Plot Square Sakkardara Umred Road Nagpur MAHARASHTRA	9552212800 agrawalgajendra2019@gmail.com
Dr Yash Paul Sharma	Post Graduate Institute of Medical Education and Research	Room No. 3012 3rd Floor Advanced Cardiac Centre, Chandigarh-160012 Chandigarh CHANDIGARH	9417167214 ypsgpgi@gmail.com
Dr Nirav Bhalani	Rhythm Heart Instituute	Rhythm Heart Institute Near Siddharth Bunglow Sama Savli Road Vadodara 390022 Vadodara GUJARAT	8128995863 drniravbhalani@hotmail.com
Dr Sachin Patil	Sachin Multispeciality Hospital	Cardiac Department, The Icon, 2nd Floor, Rajarampuri 6th Lane near Shri Ram High School, Kolhapur-416008 Kolhapur MAHARASHTRA Kolhapur MAHARASHTRA	9225068519 drsachin.crd@gmail.com
Dr Praveen Singh	Sanjeevan Hospital	24 Ansari Road Daryaganj New Delhi 110002 New Delhi DELHI	9891838824 drpraveensingh@yahoo.co.in
Dr Ravikant M Patil	Sevasadan Lifeline Suprerspeciality Hospital	Chandanwadi, Sangli-Miraj Road, Miraj, Maharashtra-41640 Sangli MAHARASHTRA	8805809993 patilrkin@yahoo.com
Dr Sunil Kumar Goel	Shantideep Hospital	Opposite District Session Court Gate Delhi Road Bulandshahr-203001 UP Bulandshahar UTTAR PRADESH	9412227913 drskgoel@rediffmail.com
Dr Pankaj Vinod Jariwala	Yashoda Healthcare Services ltd	Yashoda Hospitals Raj Bhavan Road Somajiguda Hyderabad Telangana Hyderabad TELANGANA	9393178738 docpjariwala@yahoo.co.in
Dr Prashanth RM	Yenepoya Medical College Hospital	University Road Deralakkate Mangalore 575018 Karnataka Dakshina Kannada KARNATAKA	9611777225 drprashanthrm@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 27
Name of Committee	Approval Status
All India Institute of Medical Sciences BHATINDA	Submittted/Under Review
Aster Aadhar Ethics Committee	Approved
Clinical Research Ethics Committee, Peerless Hospitex Hospital & Research Center Ltd	Submittted/Under Review
Ethics Committee Adesh University	Approved
Ethics Committee of Crescent Hospital Heart Centre	Approved
GEU GEIMS Ethical Comittee	Submittted/Under Review
GEU GEIMS Ethical Committee	Submittted/Under Review
Good Society For Ethical Research	Approved
Good Society For Ethical Research	Approved
Healthcare Ethics Committee	Approved
Himachal Heart Institute	Submittted/Under Review
IEC BKLWH	Approved
IEC-Sevasadan Lifeline Multispeciality Hospital	Approved
Institutional Ethics Committe-LLRM	Submittted/Under Review
Institutional Ethics Committee -Manipal Hospital	Approved
Institutional Ethics Committee, AIIMS Bathinda	Submittted/Under Review
Institutional Ethics Committee-KIMS	Submittted/Under Review
Institutional Ethics Committee-Lata Mangeshkar Hospital	Approved
Institutional Ethics Committee-PGIMER	Approved
Magna-Care Ethics Committee	Approved
Medanta- Institutional Ethics Committee	Approved
Medanta-Institutional Ethics Committee	Submittted/Under Review
Redkar Hospital and Research Center IEC	Approved
Rhythm Heart Institute Ethics Committee	Approved
Scientific Research and Ethical Review Committee	Approved
Sunrise Ethics Committee	Approved
Veracity Independent Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: I251\|\|Atherosclerotic heart disease of native coronary artery,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	1 Age more than 18 years 2 All Genders (Males, Females, Transgenders, Non binary) 3 Patient or legally authorized representative (LAR) agrees to participate by signing the informed consent form. 4 Patient with coronary artery disease eligible for percutaneous coronary intervention (PCI) as per regional or hospitals standard practices guidelines for PCI (For Europe as per ESC guidelines) 5 Patient with coronary artery disease having one or more de nevo or in-stent stenosis lesion in native coronary artery with a visually estimated diameter stenosis more than or equals to 70 percent 6 Patients with Reference vessel diameter of 2.0 to 4.5 mm 7 Patients with lesion length less than 48 mm

ExclusionCriteria

Details

1 Pregnant and lactating females
2 Candidates for emergency bypass Surgery
3 Patients corresponding to the criteria of a vulnerable population (Vulnerable subjects, including patients who are unable to fully understand all aspects of the investigation, patients who could be manipulated or unduly influenced, patients lacking capacity in the informed consent procedure and patients with dementia and cognitive impairment, patients under social security imprisonment etc)
4 Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) less than 30 Percent
5 Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel ticlopidine Everolimus or similar drugs, or any other analogue or derivative cobalt, chromium, nickel, molybdenum or contrast media
6 Current medical condition with a life expectancy of less than 12 months
7 Patient who have current unstable arrhythmias
8 Patient previously undergone CABG
9 Left Main Coronary Artery lesion
10 Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal dysfunction (serum creatinine more than 2.0 mg per dl or 150 µmol per L) peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 360 days of the index procedure
11 Patients with platelet count less than 100000 cells permm3 or more than 700000 cells per mm3 or a WBC less than 3000 cells per mm3

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Target Lesion Failure (TLF) defined as a hierarchical composite of Cardiac Death, target vessel oriented Myocardial infarction (TV-MI) and clinically indicated target lesion revascularization (Ci-TLR) at 360 days following implantation of RisoR Crest Everolimus Eluting Coronary stent.	360 days

Secondary Outcome

Outcome	TimePoints
Incidence of TLF (Equivalent of DoCE): -Cardiovascular Death -Target vessel Myocardial infarction (TV-MI) and -Clinically indicated target lesion revascularization (Ci-TLR).	30, 180 and 270 days
Incidence of POCE: -All cause death -Any stroke -Any myocardial infarction (includes non-target vessel territory) -Any revascularization	30, 180, 270 and 360 days
Incidence of MACE: -Cardiovascular death -Non–fatal MI -Clinically indicated Target Vessel Revascularization	30, 180, 270 and 360 days
Target vessel failure (TVF)	30, 180, 270 and 360 days
Non -Target Vessel related Myocardial Infarction	3, 30, 180, 270 and 360 days
Stent thrombosis as per -Academic Research Consortium [ARC] 2 definitions - Definite/probable -As per latency – Acute, Subacute and late.	Definite/Probable: 30, 180, 270 and 360 days Acute:0-24 hours Subacute:24 hours- 30 days late: 30-360 days
Device success: -Defined as achievement of a final residual diameter stenosis of less than 20 percent (site - reported), using the assigned device only. Successful deployment of stent with complete retrieval of delivery system without coronary dissection, device disintegration and visible malapposition and TLF.	0 hour, 24 hours, 3 days
procedural success: -Defined as achievement of a final diameter stenosis of Less than or equal to 20 percent (site-reported) using any PCI method, procedure success, Final myocardial perfusion greater than or equal to TIMI II, and MACE or Bleeding event free survival of the patient at Discharge	3 days
QCA endpoints: -In-stent and in-segment % diameter stenosis (DS) -minimum lumen diameter (MLD) -Late Lumen Loss -Angiographic binary restenosis	270 days
OCT endpoints: -Diameter Stenosis % -Proportions of in-stent and in-segment binary restenosis -Proportion of Struts uncovered and malapposed -Area restenosis -Neo-intimal hyperplasia	270 days

Target Sample Size

Total Sample Size="2000"
Sample Size from India="1960"
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)

16/08/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

10/11/2025

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
Months="2"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Open to Recruitment

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

This is a single-arm, prospective, multicentre, First Evidence Clinical study to evaluate safety and performance of RisoR Crest Everolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian (post market) and European (pre-market) populations. Enrolment of up to 1960 participants (100 QCA +50 OCT) in India and 40 in Europe is planned in the current study. The study will include patients who are planned to undergo PCI with RisoR Crest Everolimus Eluting Coronary Stent System. Patients will be followed up until 1 year post-inclusion at 30, 180, 270, and 360 days. At 270 days, 100 patients enrolled in India in the angiographic sub-group will undergo angiographic follow-up and 50 patients enrolled in the OCT sub-group will undergo OCT follow-up.