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CTRI Number  CTRI/2024/11/076901 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 10/02/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A PROSPECTIVE REGISTRY OF DRUG COATED BALLOON USE IN CORONARY INTERVENTIONS 
Scientific Title of Study
Modification(s)  		 Drug coated balloons in treatment of de novo coronary lesions: A prospective multicenter registry (Kerala DCB Registry)  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR JABIR ABDULLAKUTTY 
Designation  SR. CONSULTANT CARDIOLOGIST,  
Affiliation   
Address  LISIE HOSPITAL KOCHI KERALA

Ernakulam
KERALA
682018
India 
Phone  9447011773  
Fax    
Email  drjabi@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  DR JABIR ABDULLAKUTTY 
Designation  SR. CONSULTANT CARDIOLOGIST,  
Affiliation   
Address  LISIE HOSPITAL KOCHI KERALA

Ernakulam
KERALA
682018
India 
Phone  9447011773  
Fax    
Email  drjabi@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DR JABIR ABDULLAKUTTY 
Designation  SR. CONSULTANT CARDIOLOGIST,  
Affiliation   
Address  LISIE HOSPITAL KOCHI KERALA

Ernakulam
KERALA
682018
India 
Phone  9447011773  
Fax    
Email  drjabi@yahoo.co.in  
 
Source of Monetary or Material Support  
Cardiovascular Research Society 
 
Primary Sponsor  
Name  CARDIOVASCULAR RESEARCH SOCIETY 
Address  CARDIOLOGY RESEARCH DEPT., LISIE HOSPITAL, ERANAKULAM 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 28  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K U Natarajan  Amrita Hospital  Ponekkara Rd, P. O, Edappally, Kochi, Ernakulam, Kerala 682041
Ernakulam
KERALA 		 98950 57660

kunatarajan@gmail.com 
Dr C G Bahuleyan  Ananthapuri hospitals and Research institute(AHRI)  Thiruvananthapuram, Kerala- 695024
Thiruvananthapuram
KERALA 		 94473 44882

bahuleyan2001@yahoo.co.uk 
Dr Praveen Sreekumar  Aster Medcity  unit of M/s. Aster DM Healthcare Limited, Building No: XII/348A, Kuttisahib Road, Near Kothad Bridge, South Chittoor P.O., Cheranelloor, Kochi - 682027, Kerala, India Bridge, South Chittoor P.O., Cheranelloor, Kochi - 682027, Kerala, India
Ernakulam
KERALA 		 99958 05278

praveen_sreekumar2004@yahoo.com 
Dr Placid Sebastian K  Aster MIMS Hospital  Chala east, kannur -670624, kerala
Kannur
KERALA 		 94951 61301

placidseb@gmail.com 
Dr Salman Salahuddin   Aster MIMS Hospital  Mini Bypass Rd, Govindapuram, Kozhikode, Kerala 673016
Kozhikode
KERALA 		 99615 53414

drsalmans@gmail.com 
Dr Rajesh Muralidharan  Baby memorial Hospital  Indira Gandhi Rd, Arayidathupalam , Kozhikkode, Kerala-673004
Kozhikode
KERALA 		 94462 33343

muralidharan.rajesh@gmail.com 
Dr Zameel  CRAFT Hospital and Research Center  Kodugalloor, Thrissur, Kerala
Thrissur
KERALA 		 8301812597

mail2zameel@gmail.com 
Dr Shyam Lakshman SG  Government Medical College, Kannur  Government MC Kannur Campus Rd, Pariyaram, Kerala 670503
Kannur
KERALA 		 77365 25522

drshyam.kmc.lakshman@gmail.com 
Dr Manoj Ravi  Jubilee Mission Medical College & Research Institute  Bishop Alappat Road, Thrissur East, Kerala- 680005
Thrissur
KERALA 		 96050 05444

mrcardio@gmail.com 
Dr Ramesh Natarajan  KIMS Health Care Management   Limited,Anayara, Thiruvananthapuram, Kerala, 695029
Thiruvananthapuram
KERALA 		 93493 29698

natarajanramesh79@gmail.com 
Dr Anand Kumar V  Lakeshore Hospital And Research Centre   Ltd XVI/612,Maradu,Nettoor PO,Kochi-682040
Ernakulam
KERALA 		 92494 88064

anandheart@gmail.com 
Dr Anil Balachandran  LAKSHMI HOSPITAL   Divans Rd, Pallimukku, Kochi, Ernakulam, Kerala 682016
Ernakulam
KERALA 		 98462 12213

docabc@gmail.com 
Dr Jayagopal P B  Lakshmi Hospital   Chittur Road Palakkad – 678 013
Palakkad
KERALA 		 98470 23777

jayagopallakshmi@gmail.com 
Dr Rony Mathew  Lisie Hospital  Kacheripady PO Eranakulam 682018
Ernakulam
KERALA 		 9846097812

drronymathew@yahoo.com 
Dr Sajan Narayanan  Little Flower Hospital & research Centre  Angamaly P.O, Angamaly, Kerala-683572
Ernakulam
KERALA 		 80868 42627

sajannarayanan@gmail.com 
Dr James Thomas  Mar Sleeva Medicity Palai  Cherpunkal, Kezhuvankulam P.O. Pala 686584
Kottayam
KERALA 		 94471 26044

drjamescardio@gmail.com 
Dr Shafeeq Mattummal  Meitra Hospital  Karaparamba- Kunduparampa Mini Bypass Road, Edakkad P.O, Kozhikode- 673005
Kozhikode
KERALA 		 99476 67762

drshafeeqm@gmail.com 
Dr Arun Gopi  Metromed International Cardiac center Pvt Ltd  Thondayad Bypass Road, Kozhikkode, Kerala,673014
Kozhikode
KERALA 		 81570 47371

arungopi@gmail.com 
Dr Mathews Paul  Moulana Hospital  Perinthalmanna, Malapppuram (Dist), Kerala-679322
Malappuram
KERALA 		 96453 70460

drmpaul@yahoo.com 
Dr Renjukumar B C  Polakulath Narayanan Renai Medicity  Palarivattom P O , Kochi, Kerala 682025
Ernakulam
KERALA 		 94951 37137

renjukumarbc@yahoo.com 
Dr Suresh Davis  Rajagiri Hospital  Chunangamvely, Aluva – 683112
Ernakulam
KERALA 		 82813 63184

davissuresh@yahoo.co.in 
Dr Anoop Gopinath  RAJIV GANDHI COOPERATIVE HOSPITAL  Court Rd, Santhi Nagar, Sultanpet, Palakkad, Kerala 678001
Palakkad
KERALA 		 97440 68178

dranoopgopinath@gmail.com 
Dr Arshad M  SK Hospital   Edappazhanji junction, Thiruvananthapuram, Kerala 695006
Thiruvananthapuram
KERALA 		 98958 84285

shan75in@yahoo.com 
Dr Musna P J  St Marys Hospital  Thodupuzha, Idukki, Pin 685584
Idukki
KERALA 		 98958 77636

musna.p.j@gmail.com 
Dr Jayesh Bhaskaran  Starcare Hospital  N H Bypass Junction, Near Thondayad, Kozhikode, Kerala 673017
Kozhikode
KERALA 		 93495 95955

drjayeshb@gmail.com 
Dr Praveen G K  SUT Hospital  Near, Palace View Rd, Vrindavan Gardens, Pattom, Thiruvananthapuram, Kerala 695004
Thiruvananthapuram
KERALA 		 98469 40049

drgkpraveen@gmail.com 
Dr Sajan Ahmad Z  The Lifeline Multispeciality Hospital  Melood P.O, Adoor, Pathanamthitta Kerala 691554
Pathanamthitta
KERALA 		 94470 97965

sajanahamad@gmail.com 
Dr Abhilash T G  Travancore Medical College Hospital   N H Bypass, Mylapore, Thattamala P.O, Kollam, Kerala- 691020
Kollam
KERALA 		 94472 07588

drabhilashtg@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 22  
Name of Committee  Approval Status 
DIABCARE INDIA INSTITUTIONAL ETHICS COMMITTEE  Approved 
Institutional Ethic Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee Aster MIMS Hospital  Approved 
Institutional Ethics Committee, Ananthapuri Hospital  Approved 
Institutional Ethics Committee, Baby memorial Hospital  Approved 
Institutional Ethics Committee, Craft Hospital and Research Center  Approved 
Institutional Ethics Committee, Jubilee Mission Medical College and Research Institute  Approved 
Institutional Ethics Committee, Lakeshore Hospital  Approved 
Institutional Ethics Committee, Lakshmi Hospital  Approved 
Institutional Ethics Committee, Lisie Hospital  Approved 
Institutional Ethics Committee, Little Flower Hospital  Approved 
Institutional Ethics Committee, Malabar Institute of Medical Science LTD.(MIMS)  Approved 
Institutional Ethics Committee, Meitra Hospital  Approved 
Institutional Ethics Committee, Rajagiri Hospital  Approved 
Institutional Ethics Committee, Renai Medicity  Approved 
Institutional Ethics Moulana Committee, Hospital  Approved 
INSTITUTIONAL HUMAN ETHICS COMMITTEE  Approved 
Institutional Human Ethics Committee  Approved 
Institutional Human Ethics Committee, KIMSHEALTH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I20-I25||Ischemic heart diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients who are more than 18 years undergoing PCI to native vessel with DCB and
Vessels with reference diameter 2.0 – 4mm 
 
ExclusionCriteria 
Details  Saphenous vein graft & other bypass graft lesions
Left main
Severe tourtous lesions
Heavily calcified lesions
Vessel diameter morethan 4.0mm
Expected life expectancy less than 1 year
Severe liver disease lessthan Child Pugh B
Severe CKD eGFR morethan 30ml/min/m2
Advanced malignancy
Known contraindication for paclitaxel or sirolimus  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study clinical
procedural characteristics of patients
undergoing PCI with DCB in native vessel disease
Lesion sub sets like large vessel morethan 3.0mm 		 In hospital
30 days
3 days
6 days
12 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Long lesions-bifurcations-Chronic total occlusions CTO, proximal
vessel disease receiving DCB treatment are of special interest-Clinical subsets
like ST elevation myocardial infarction STEMI- non ST elevation acute coronary
syndromes NSTEACS are to be studied 		 In hospital
30 days
3 days
6 days
12 months
 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   25/11/2024 
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
Modification(s)  		 Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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   To study clinical, procedural characteristics of  patients undergoing PCI with DCB in native vessel disease. Lesion subsets like large vessel (>3.0 mm), long lesions, bifurcations, chronic total occlusions (CTO), proximal vessel disease receiving DCB treatment are of special interest. Clinical subsets like ST elevations myocardial infarction (STEMI) , Non ST elevations acute coronary syndrome are to be studied. 

 
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