Academics and Research Department, Batra Hospital & Medical Research Centre,1, Tughlakabad Institutional Area, Mehrauli Badarpur Road, New Delhi, India
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad -121003, Haryana, India
B.M. Birla Heart Research Centre, 1/1, National Library Avenue,
Kolkata-700027, West Bengal, India
Kolkata WEST BENGAL
9830048563
dhiman.kahali@gmail.com
Dr John F John
Baby Memorial Hospital
Baby Memorial Hospital, Indira Gandhi Road, Kozhikode-673 004, Kerala Kozhikode KERALA
9447690630
jfjrrt4@gmail.com
Dr Darshan Banker
Bankers Heart Institute
Bankers Heart Institute,
Near Tagorenagar,
Opp. Suryakiran Complex,
Old Padra Road,
Vadodara - 390015
Vadodara GUJARAT
9825029727
dnb@bankersheart.com
Dr Upendra Kaul
Batra Hospital and Medical Research Centre
Academics and Research Department, 1, Tughlakabad Institutional Area, Mehrauli Badarpur Road, 110062 New Delhi DELHI
9811150518
kaul.upendra@gmail.com
Dr Kushal Pujara
Bhanubhai & Madhuben Patel Cardiac Centre, Shree Krishna Hospital and Medical Research Centre
Bhanubhai & Madhuben Patel
Cardiac Centre, Shree Krishna Hospital and Medical Research Centre, Gokal Nagar, Karamsad 388325, Gujarat, India
Anand GUJARAT
9825175197
drkushalpujara@yahoo.com
Dr Vithala Surya Prakasa Rao
Care Hospital, Road No.1, Banjara Hills, Hyderabad
Care Hospital, Road No.1, Banjara Hills,
Hyderabad -500034 Telangana, India
Hyderabad TELANGANA
9848051215
sp.vithala@yahoo.com
Dr Deepak Davidson
Caritas Hospital
Caritas Hospital, Off M.C. Road, Thellakom,
Kottayam- 686630, Kerala.
Kottayam KERALA
Dayanand Medical College and Hospital, (A Unit of Hero DMC Heart), Tagore Nagar, Ludhiana - 141001, Punjab, India Ludhiana PUNJAB
9876741158
bishav_68@yahoo.co.in
Dr Narasimha Pai D
Department of Cardiology Kasturba Medical College Hospital Dr. B. R. Ambedkar Circle, Karnataka
Department of Cardiology Kasturba
Medical College Hospital Dr. B. R. Ambedkar Circle, Mangaluru-575001, Karnataka, India.
Dakshina Kannada KARNATAKA
9449664407
narasimhapai@yahoo.com
Dr Rajesh Sharma
Department of Cardiology, Indira Gandhi Medical College
Department of Cardiology, Indira Gandhi Medical College, Shimla Shimla HIMACHAL PRADESH
9805328594
Rajeshdrsharma1972@gmail.com
Dr Praveen SV
Department of Cardiology, Kerala Institute of Medical Sciences
Department of Cardiology, Kerala Institute of Medical Sciences, P.B. No. 1 Anayara
P.O., Trivandrum-695029, Kerala, India
Thiruvananthapuram KERALA
9895088677
drpraveencardio@gmail.com
Dr KMK Reddy P
Dept. of Cardiology, Room No: 9049, Apollo Hospitals, Hyderabad
Dept. of Cardiology, Room No: 9049,
Apollo Hospitals, Jubilee Hills,
Hyderabad – 500096, Telangana State,
India
Hyderabad TELANGANA
9848015098
drkmkreddyp@yahoo.com
Dr Subhash Chandra
Dr. B.L .Kapur Memorial Hospital
1st floor, OPD-3, Dr. B.L. Kapur Memorial Hospital, Pusa Road, New Delhi-110005, India. New Delhi DELHI
9810075983
drsubhashchandra26@gmail.com
Dr Amresh kumar Singh
Dr. Ram Manohar Lohia Institute of Medical Sciences.
Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow- 226010 Lucknow UTTAR PRADESH
916387842488
dramresh.singh5@gmail.com
Dr Sanjeev K Sharma
Eternal Multispecialty Hospital
Department of clinical research Basement no 2 Eternal Multispecialty Hospital Jagatpura Road Near Jawahar Circle Chainpura Malviya Nagar Jaipur Rajasthan 302017 Jaipur RAJASTHAN
9983333421
sanzsharma@gmail.com
Dr Neil Bardoloi
Excelcare Hospitals
Paschim Boragaon, NH-37, Near Ganesh Mandir, Guwahati-781033, Assam Jorhat ASSAM
9435703742
neilbard@rediffmail.com
Dr Ashok Seth
Fortis Escorts Heart Institute
Okhla road, Sukhdev Vihar Metro Station, 110025 South DELHI
9810025814
ashok.seth@fortishealthcare.com
Dr Atul Mathur
Fortis Escorts Heart Institute
Okhla road, Sukhdev Vihar Metro Station, 110025 New Delhi DELHI
01147135000
atul.mathur@fortishealthcare.com
Dr Nityanand Tripathi
Fortis Hospital
Fortis Hospital, A Block, Shalimar Bagh, New Delhi-110088, India New Delhi DELHI
9971365522
tripathinityanand@gmail.com
Dr Shuvanan Ray
Fortis Hospital
730, Anandapur, EM Bypass Road Kolkata-700107, West Bengal, India Kolkata WEST BENGAL
Department of cardiology,2nd floor, room number 208, Healthworld Hospitals, C49 Commercial Area, opp ESIC Sub Regional Office, Pin-713216, Durgapur, West Bengal Barddhaman WEST BENGAL
8170052601
ashokparidatrial@gmail.com
Dr Bhavesh Meel
Heart and General Hospital
Heart and General Hospital, 7 Vivekanand Marg, C- Scheme, Jaipur-302001, Rajasthan, India Jaipur RAJASTHAN
8003692691
bhavesh_meel@rediffmail.com
Dr Brian Pinto
Holy Family Hospital & Medical Research Centre
St Andrews Rd, Bandra West, Mumbai-400050, Maharashtra, India Mumbai MAHARASHTRA
9820054913
bpiifc@gmail.com
Dr Bhasin Anuj
ICON Heart Care Hospital
ICON Heart Care, 6 th floor,ICON Hospital, Mahavir Nagar Corner, Dombivli, 421201 Maharashtra India Thane MAHARASHTRA
9167400400
dranujbhasin@gmail.com
Dr Jaskaran Singh Dugal
Jehangir Clinical Development Center Pvt. Ltd.
Jehangir Clinical Development Centre. Pvt. Ltd.
Jehangir hospital, Premises 32 Sassoon road, Pune - 411001, Maharashtra.
Pune MAHARASHTRA
9822050945
tonydugal@yahoo.co.in
Dr Prafulla Kerkar
K.E.M Hospital and Seth G. S Medical College
K.E.M Hospital and Seth G. S Medical College, Parel Mumbai - 400012 Mumbai MAHARASHTRA
9820144111
prafullakerkar@rediffmail.com
Dr Bhagwat Ajit Raghunath
Kamalnayan Bajaj Hospital
Kamalnayan Bajaj Hospital, Gut No. 43, Satara Parisar, Bajaj Marg, Beed Bypass
Road, Aurangabad-431010, Maharashtra, India
Aurangabad MAHARASHTRA
9822050817
drajitbhagwat@gmail.com
Dr RK Premchand
KIMS Hospital
Krishna Institute of Medical Sciences, 1-8-31/1, Minister Road, Secunderabad-500003, Telangana, India Hyderabad TELANGANA
9848029443
kumarpre@hotmail.com
Dr Sharad Chandra
King George’s Medical University, Department of Cardiology
King George’s Medical University, Department of Cardiology, Lucknow-226003, Uttar Pradesh, India
Lucknow UTTAR PRADESH
9616279212
sharadaiims@gmail.com
Dr Sanjay Porwal
KLES, Dr Prabhakar Kore hospital and MRC
KLES Dr Prabhakar Kore hospital and MRC, Nehru Nagar, Belagavi – 590010 Karnataka, India Belgaum KARNATAKA
(1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Supraflex Cruz Sirolimus-eluting coronary stent system
Supraflex Cruz is the latest generation DES, approved by DCGI and has received CE mark approval in June-2019 in the European Union
Comparator Agent
Xience Family Everolimus-eluting coronary stent system
It is considered to be the current standard for DES given the ease of use and clinical performance.
XIENCE with a Chromium cobalt platform (81um thick) has a more biocompatible durable fluro polymer
1.Age greater or equal to 18 years
2.Patient with diabetes mellitus (Type 1 or Type 2)
3.Angiographically confirmed multivessel CAD [critical (greater or equal to 70 percent) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA]. The population will consist of approximately 85percent patients with triple vessel disease
4.Angiographic characteristics amenable to PCI as decided by the heart team
5.Indication for revascularization based upon symptoms of angina or angina equivalents andor objective evidence of myocardial ischemia
6.Willing to comply with all follow-up required study visits
7.Signed informed consent
ExclusionCriteria
Details
1.Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment.
2.Prior CABG surgery.
3.Prior PCI with stent implantation within 6 months.
4.Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement, as reflected in a Rankin Score greater 1.
5.Prior history of significant bleeding (within the previous 6 months) that might preclude use of dual antiplatelet therapy.
6.In-stent restenosis of a target vessel.
7.Two or more chronic total occlusions in major coronary territories that are targeted for revascularization.
8.Acute ST-elevation MI (Q-wave) within 72 hours prior to enrollment requiring revascularization.
9.Contraindication to PCI because of a coexisting clinical condition
10.Intolerance or contraindication to aspirin or both clopidogrel and ticagrelor or prasugrel.
11.Extra-cardiac illness that is expected to limit survival to less than 5 years.
12.Women who are pregnant, nursing, or who plans to become pregnant while the study.
13.Concurrent enrollment in another clinical trial
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
1. To compare clinical outcomes of percutaneous coronary intervention (PCI) with the ultrathin Supraflex Cruz vs. Xience family when combined with contemporary optimal medical therapy (OMT) in patients with diabetes mellitus and multi vessel disease with respect to target lesion failure (TLF)
At 12 months
Secondary Outcome
Outcome
TimePoints
To evaluate whether the pooled cohort from both arms of the study (Supraflex Cruz and Xience family) provides similar clinical outcomes (composite of all-cause mortality, nonfatal myocardial infarction (MI), or stroke) to the coronary artery bypass graft surgery based on performance goal derived from the CABG arm of the FREEDOM trial (historical control)
up to 5 years.
Target Sample Size
Total Sample Size="1800" Sample Size from India="1800" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
This is a prospective, open-label, multicenter, randomized 2 x 2 factorial design study in patients with diabetes mellitus and multivessel disease with an indication for revascularization. Participants will be randomized to receive either Supraflex Cruz or the Xience family of stents, and to either Ticagrelor or Prasugrel (in addition to aspirin)
The tertiary
objective is to compare the outcomes of Ticagrelor versus Prasugrel, in
addition to aspirin, on the composite of death, myocardial infarction (MI),
stroke, or BARC major bleeding at 12 months.