| CTRI Number |
CTRI/2022/03/040921 [Registered on: 08/03/2022] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Registry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational registry study on the use of ENCRUSO RAL- Everolimus eluting stent in indian population |
|
Scientific Title of Study
|
A ProSpective, multicentre, registry to evalUate the Clinical outCome of Encruso RAL-Everolimus
Eluting Coronary Stent System in real world percutaneOus coronary revasculaRization in Indian population- SUCCESSOR |
| Trial Acronym |
SUCCESSOR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Upendra Kaul |
| Designation |
Chairman Batra Heart Centre and Dean Academics and Research |
| Affiliation |
Batra Hospital and Medical Research Centre |
| Address |
Batra Heart Centre, 1st floor, Room No. 17, 1, Tughlakabad Institutional Area
Mehrauli Badarpur Road
New Delhi
DELHI
110062
India |
| Phone |
09811150518 |
| Fax |
|
| Email |
upendra.kaul@batrahospitaldelhi.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Upendra Kaul |
| Designation |
Chairman Batra Heart Centre and Dean Academics and Research |
| Affiliation |
Batra Hospital and Medical Research Centre |
| Address |
Batra Heart Centre, 1st floor, Room No. 17, 1, Tughlakabad Institutional Area
Mehrauli Badarpur Road
New Delhi
DELHI
110062
India |
| Phone |
09811150518 |
| Fax |
|
| Email |
upendra.kaul@batrahospitaldelhi.org |
|
Details of Contact Person
Public Query
|
| Name |
Priyadarshini Arambam |
| Designation |
Project Manager |
| Affiliation |
Clicebo Solutions Private Limited |
| Address |
Room No. 1, N 28 Ground Floor CR Park
South
DELHI
110019
India |
| Phone |
9910990347 |
| Fax |
|
| Email |
priyadarshini@clicebo.com |
|
|
Source of Monetary or Material Support
|
| Nano Therapeutics Private Limited |
|
|
Primary Sponsor
|
| Name |
Nano Therapeutics Private Limited |
| Address |
Plot no. D-54/2, Hojiwala Industrial Estate, Road No. 23, Near Gate
No. 3 Sachin Palsana Highway, Sachin, Surat-394230, Gujarat, India |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 18 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sameer I Dani |
Apollo CVHF Heart Institute |
A unit of Apollo CVHF Limited, Department of Cardiology, Opp. GNFC Tower, Pakwan Cross Road, S.G. Highway, Bodakdeb, Ahmedabad-380059
Ahmadabad
GUJARAT |
9825038855
drsameerdani@yahoo.com |
| Dr Dhiman Kahali |
B M Birla Heart Research Centre |
Department of Cardiology,1/1 National Library Avenue, Kolkata-700027
Kolkata
WEST BENGAL |
9830048563
dhiman.kahali@gmail.com |
| Dr Upendra Kaul |
Batra Hospital and Medical Research Centre |
Room no. 17, 1st Floor, Batra Heart Centre, 1, Tughlakabad Institutional Area
Mehrauli Badarpur Road
New Delhi
DELHI |
09811150518
upendra.kaul@batrahospitaldelhi.org |
| Dr N Raja Ramesh |
Dr. Ramesh Cardiac and Multispecialty Hospital Pvt Ltd Pvt. Ltd |
Ring Road, Near ITI College
Vijaywada-520008
Krishna
ANDHRA PRADESH |
8662463463
nukavarapuraja@gmail.com |
| Dr Ashok Kumar Parida |
HEALTHWORLD HOSPITALS |
C-49 Commercial Area, opp ESIC Sub-Regional Office
Durgapur, West Bengal 713216
Barddhaman
WEST BENGAL |
9932000556
ashokparida@gmail.com |
| Dr Basavaraj Utagi |
Justice K S Hegde Charitable Hospital |
DEPARTMENT OF CARDIOLOGY, DERALAKATTE, MANGALORE UNIVERSITY ROAD, MANGALORE -575018
Dakshina Kannada
KARNATAKA |
8660294608
basavaraj.utagi@gmail.com |
| Dr Tom Devasia |
Kasturba Hospital |
Department of Cardiology KMC Manipal ,Udupi Karnataka 576104
Udupi
KARNATAKA |
9448158508
tomdevasia@hotmail.com |
| Dr SK Sinha |
LPS Institute of cardiology and Cardiac surgery |
Room No.13 3rd floor GSVM Medical College, Swaroop Nagar
Kanpur, Uttar Pradesh-208002
Kanpur Dehat
UTTAR PRADESH |
9670220088
fionasan@rediffmail.com |
| Dr BB Chanana |
Maharaja Agrasen Hospital |
West Punjabi Bagh, New Delhi-110026
West
DELHI |
9810109195
bbchanana@yahoo.com |
| Dr Rakesh Rai Sapra |
Marengo QRG Hospital |
Plot No, 1 Sector- 16, Faridabad, Haryana 121002
Faridabad
HARYANA |
9811335464
saprarakesh@hotmail.com |
| Dr Rohit Mody |
Max Super Speciality Hospital |
NH-64, Near District Civil Hospital,
Mansa Road, Bathinda, Punjab 151 001
Bathinda
PUNJAB |
9888925988
drmody_2k@yahoo.com |
| Dr Manoj Kumar |
Max Super Speciality Hospital, Patparganj |
Department of Cardiology, 108-A, IP Extension, Patparganj, New Delhi-110092
East
DELHI |
9811506252
manoj.kumar@maxhealthcare.com |
| Dr Viveka Kumar |
Max Super Speciality Hospital, Saket (A Unit of Devki Devi Foundation) |
East Block, Department of Cardiac Sciences, 2, Press Enclave Road, Saket-110017
New Delhi
DELHI |
9871001190
viveka.kumar@maxhealthcare.com |
| Dr Yash Paul Sharma |
PGIMER |
Department of Cardiology, Sector-12 Chandigarh-160012 India
Chandigarh
CHANDIGARH |
9417167214
ypspgi@gmail.com |
| Dr Ganesh Vilas Manudhane |
Sevenhills Hospital |
Department of Cardiology,Marol Maroshi road, Andhaeri East, Mumbai, Maharasatra-400059
Mumbai
MAHARASHTRA |
7276705766
drganeshmanudhane@gmail.com |
| Dr Nikhil D Parikh |
Soni Hospital |
38, Kanota Bagh, JLN Marg,Near Birla Mandir,Jaipur,Rajasthan-302004
Jaipur
RAJASTHAN |
9829054944
nikhil17961@gmail.com |
| Dr Bijulal Sasidharan |
Sree Chitra Tirunal lnstitute for Medical Sciences and Technology |
Department of Cardiology Jai Nagar W Rd, Chalakkuzhi, Thiruvananthapuram 695011
Thiruvananthapuram
KERALA |
9446590185
bijulalsasidharan@gmail.com |
| Dr Shanmugam Krishnan |
Sri Jayadeva Institute of Cardiovascular Sciences & Research |
Department of Cardiology,Bannerghatta Road, Jayanagar, Bangaluru-560069
Bangalore
KARNATAKA |
9968889887
shanmugammmc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 18 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical College , Kanpur |
Approved |
| Central Ethics Committee |
Approved |
| Healthworld Hospitals Institutional Ethics Committee |
Approved |
| IEC PGIMER, Chandigarh |
Approved |
| Institutional Ethics Committee , Apollo Hospitals, Gandhinagar |
Approved |
| Institutional Ethics Committee, B M Birla Heart Research Centre |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Hospital |
Approved |
| Institutional Ethics Committee, Max Super Speciality Hospital ,Bathinda |
Approved |
| Institutional Ethics Committee, max Super Speciality Hospital, Patparganj |
Approved |
| Institutional Ethics Committee, Ramesh Hospital, Vijaywada |
Approved |
| Institutional Ethics Committee,Devki Devi Foundation |
Approved |
| Institutional Ethics Committee,SCTIMST |
Approved |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
| Medical Ethics Committee Sevenhills |
Approved |
| QRG Medicare Ethics Committee |
Approved |
| Scientific Research and Ethical Review Committee |
Approved |
| Somex Research & Health Ethics Committee |
Approved |
| Sri Jayadeva Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
98.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female patient who is 18 years and above
2.Patients undergoing percutaneous coronary intervention with Encruso RAL-Everolimus Eluting Coronary Stent System
3.Patient or legal guardian understands the study requirements and provides written informed consent
4.Patient who is on dual antiplatelet therapy for at least 6 months post procedure |
|
| ExclusionCriteria |
| Details |
1.Patient has known hypersensitivity or allergies to Aspirin, Heparin,Clopidogrel, Ticlopidine, Everolimus or similar drugs, or any other
analogue or derivative, cobalt, chromium, or contrast media
2.Patient with life expectancy less than 2 years
3.Pregnant and lactating females or planning to become pregnant while in the study
4.Patient currently participating in another investigational drug or device clinical trial |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Target Lesion Failure (TLF) rate
A composite endpoint of Cardiac Death
Target Vessel related Myocardial Infarction (MI)
and
Clinically driven Target Lesion Revascularization
(TLR) at 1 year follow-up
OCT sub study:
Strut-level analysis
Proportion of covered struts
o Thickness of neointimal hyperplasia (NIH) over
covered struts
Proportion of malapposed struts
Mean malapposed strut to lumen distance
Ratio of uncovered struts to total struts
Maximum length of consecutive segments of uncovered and malapposed struts
Cross-section level analysis:
NIH area, volume
Percent volumetric stent obstruction
Incomplete stent apposition (ISA) area and volume |
1 year
OCT sub study: 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Target Vessel Failure (TVF) rate
ID-TVR
ID-TLR
TV-MI
Patient oriented composite endpoint (a composite endpoint of all cause death, all myocardial infarction, and all revascularization)
Major Adverse Cardiac Events (MACE) which is
the composite endpoint of cardiac death,non-fatal myocardial infarction and non-fatal stroke
Nonfatal MI
Cardiac death (death from cardiac cause)
All cause death (including cardiac & non cardiac
death)
Stent thrombosis (defined by Academic Research Consortium [ARC] criteria) |
2 year |
Procedural endpoints:
Device success (residual coronary stenosis less than 50 %, normal coronary flow and absence of coronary dissection)
Device success and absence of PCI complication (periprocedural MI, coronary
perforation, urgent CABG or death) or revascularization within 3 days |
3 days |
OCT SUB STUDY:
Mean and minimum lumen area and volume
Stent expansion, eccentricity and symmetry
Mean and minimum lumen area and volume ISA area and volume
Proportion of malapposed struts, mean malapposed strut-to-lumen distance |
post procedure |
OCT SUB STUDY:
Serial changes in mean lumen area, minimum lumen area, and ISA area from post procedure to 6 months
Proportion of cross sections with peri strut low
intensity areas (PLIA) and neoatherosclerosis
Quantification of NIH backscattering, attenuation
and optical intensity |
6 months |
OCT SUB STUDY:
Angiographic Endpoint:
In-stent and in-segment acute gain post procedure
Diameter stenosis percent at post procedure and
6 months
In-stent area late loss (LL) at 6 months
In-segment late loss at 6 months
In-stent area and in-segment area % diameter
stenosis post procedure and at 6-months
In-stent area and in-segment angiographic
binary restenosis rate at 6-months
Aneurysm, thrombus and persisting dissection at
6 months |
6 month |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
21/03/2022 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a prospective, multi-center, non-randomized, registry study with clinical follow up to be conducted at 30 days, 180 days, year 1 and year 2 post index procedure. 500 patients to receive treatment with the Encruso RAL-Everolimus Eluting Coronary Stent.The primary objective of the study is to evaluate the safety and efficacy of the Encruso RAL-Everolimus eluting coronary stent system implanted during routine clinical practice in India at 1 year follow up. 50 patients out of 500 will be included in the OCT sub study. The primary objective of the study is to evaluate the malapposition, degree of strut coverage and vessel wall response after implantation of Encruso RAL-Everolimus Eluting Coronary Stent by Optical Coherence Tomography at 6 months angiographic follow up. The sub study is designed to run seamlessly with the main study but sites can opt out if they choose not to participate. |