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1 Clinical Trial Details (PDF Generation Date :- Mon, 03 Sep :53:19 GMT) CTRI Number Last Modified On 23/06/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/07/ [Registered on: 16/07/2012] - Trial Registered Prospectively No PMS Medical Device Other This is an investigator initiated study to compare the safety and performance of the Promus Element Stent System in the treatment of Coronary lesion in Indian population A Prospective, Multi-Center Registry to assess Everolimus-Eluting Coronary Stent System (PROMUS Element ) for Coronary Revascularization in an Indian Population of Unrestricted Patients Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) PROMUS Element India All Comers Registry Name Designation Affiliation Address Other Details of Principal Investigator Dr Ajit Mullasari MD Director of Cardiology Phone Fax Name Designation Affiliation Address The Madras Medical Mission Institute of Cardio Vascular Diseases The Madras Medical Mission No. 4-A, Dr. J. Jayalalitha Nagar, Mogappair, India clireco@mmm.org.in Details Contact Person (Scientific Query) Dr Ajit Mullasari MD Director of Cardiology Phone Fax Name Designation Affiliation Address The Madras Medical Mission Institute of Cardio Vascular Diseases The Madras Medical Mission No. 4-A, Dr. J. Jayalalitha Nagar, Mogappair, India clireco@mmm.org.in Details Contact Person (Public Query) Dr Ajit Mullasari MD Director of Cardiology The Madras Medical Mission Institute of Cardio Vascular Diseases The Madras Medical Mission No. 4-A, Dr. J. Jayalalitha Nagar, Mogappair, India page 1 / 10

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > The Madras Medical Mission No. 4-A, Dr. J. Jayalalitha Nagar, Mogappair, , Tamil Nadu, India Name Address Type of Sponsor Name Dr Ajit Mullasari List of Countries India Name of Principal Investigator Primary Sponsor Details Institute of Cardio Vascular Diseases The Madras Medical Mission Institute of Cardio Vascular Diseases The Madras Medical Mission Research institution and hospital Address Institute of Cardio Vascular Diseases The Madras Medical Mission No. 4A Dr. J. Jayalalitha Nagar Mogappair Tamil Nadu India Name of Site Site Address Phone/Fax/ Dr Sanjay Shah Apex Heart Institute No. G-K Mondeal Business Park, Near Gurudwara, S. G. Highway, Ahmedabad Ahmadabad drscshah@gmail.com Dr Mathew Samuel K Apollo Hospital Apollo Hospital, 21 Greams Lane, Dr P C Rath Apollo Hospital Interventional Cardiologist Apollo Hospital, Jubilee Hills, Hyderabad Hyderabad ANDHRA PRADESH Dr Darshan Banker Bankers Heart Institute Cardiologist Near Tagore Nagar Opp Suryakiren Complex Old Padra Road Vadodara , Vadodara mskalarickal@yahoo.co m drpcrath@hotmail.com dnb@bankersheart.com Dr A Srinivas Kumar Care Hospital Consultant Cardiologist Care Hospital, Road No 1, Banjara Hills, Hyderabad Hyderabad ANDHRA PRADESH arramraj@yahoo.com Dr Deepak Davidson Caritas Heart Institute Chief Interventional Cardiologist Caritas Heart Institute, Caritas Hospital, Thellakom P. O., Kottayam , drdeepakdavidson@ya hoo.com page 2 / 10

3 Dr Shireesh Sathe Dr Narendra Singh Tanwar Dr Upendra Kaul Deenanath Mangeshkar Hospital and Research Centre DWTI Prabhu General and Bankers Heart Institute Fortis Escorts Heart Institute Kottayam KERALA HOD, Dept of Cardiology Erandwane, Pune Pune Director Cath Lab, DWTI Prabhu General and Bankers Heart Institute, Surat Surat Executive Director and Dean - Cardiology Fortis Escorts Heart Institute, Okhla Road New Delhi DELHI Dr Arun K Chopra Fortis Escorts Hospital Principal Interventional Cardiologist Fortis Escorts Hospital, Majitha Verka Bypass Road, Amritsar Amritsar PUNJAB Dr Sanjeeb Roy Fortis Escorts Hospital, Sr. Consultant Cardiology Fortis Escorts Hospital, Jawahar Lal Nehru Marg, Malviya Nagar, Jaipur , Rajasthan, Jaipur RAJASTHAN shireesh.sathe@gmail.c om ntanwar@gmail.com upendra.kaul@fortishea lthcare.com arun.chopra@fortishealt hcare.com sanjeeb.roy@fortishealt hcare.com Dr Harinder K Bali Fortis Hospital Director Cardiology Fortis Hospital, Sector-62, Phase VIII, harinder.bali@fortisheal Mohali , thcare.com Chandigarh CHANDIGARH Dr Rajpal K Abhaichand G. Kuppuswamy Naidu Memorial Hospital, Dr Brian Pinto DrAjit Bhagwat Holy Family Hospital-Diagnostic Services Kamalnayan Bajaj Hospital P. B. No. 6327, Nethaji Road, Papanaickenpalayam, Coimbatore Coimbatore rajtrials@yahoo.com Consultant Cardiologist St. Andrews Road, Bandra (West), Mumbai bpiifc@gmail.com Mumbai Director Cardiac lab & Interventional Cardiology Gut No. 43, Satara Parisar, Beed drajitbhagwat@gmail.co m page 3 / 10

4 Dr Rakesh Chand Jindal Dr Thomas Alexander Dr R K Premchand Dr Sameer I Dani Bypass Road, Aurangabad Aurangabad Kota Heart Institute 10-A, Talwandi, Kota , Rajasthan Kota RAJASTHAN Kovai Medical Center and Hospital Krishna institute of Medical Sciences Life Care Institute of Medical Sciences and Research Consultant and Interventional Cardiologist Kovai Medical Center and Hospital, Post Box No. 3209, Avanashi Road, Coimbatore Coimbatore Interventional Cardiologist Krishna institute of Medical Sciences, # /1, Minister Road, Secunderabad Hyderabad ANDHRA PRADESH Interventional Cardiologist Sardar Patel Statue Corner Ahmadabad Dr Rony Mathew Lisie Hospital HOD and Consultant Cardiologist Department of Cardiology, Lisie Hospital, Cochin Ernakulam KERALA Dr Rajneesh Kapoor Medanta - The Medicity Cardiologist Medanta - The Medicity, Sector - 38, Gurgaon Gurgaon HARYANA DrVikas Bisne Dr S Selvamani Meditrina Institute of Medical Sciences Meenakshi Mission Hospital and Research Centre Dr Madhu Shreedharan NIMS, Medicity, 278-Central Bazar Road, Ramdaspeth, Nagpur Nagpur Cardiologist Meenakshi Mission Hospital and Research Centre,Lake Area, Melur Road Madurai Madurai Director - NIMS Heart Foundation NIMS, rakeshcjindal@yahoo.c o.in tomalex41@gmail.com kumarpre@hotmail.com danisameer@hotmail.c om drronymathew@yahoo. com rajneesh.kapoor@meda nta.org vikasbisne@gmail.com maniselva@hotmail.co m page 4 / 10

5 Dr Rajesh Rajani Dr Shirish M S Hiremath Dr Atul Abhyankar Dr Devang Desai Dr Kiron Varghese Dr Nitish Garg Dr Ajit Mullasari P. D. Hinduja National Hospital and Medical Research Centre Ruby Hall Clinic Shree B.D. Mehta Mahavir Heart Institute Shri B. D. Mehta Mahavir Heart Institute St. John s Medical College Hospital Tagore Hospital and Heart Care Centre Pvt. Ltd., The Madras Medical Mission Hospital Medicity, Aralumoodu, Neyyattinkara, Thiruvananthapuram Thiruvananthapuram KERALA Consultant Cardiologist P. D. Hinduja National Hospital and Medical Research Centre, Veer Savarkar Marg, Mahim, Mumbai Mumbai Consultant Cardiologist and Director Sassoon Road, Pune Pune madhusreedharan@ya hoo.com dr_rrajani@hindujahosp ital.com shirish.hiremath@rediff mail.com Clinical Director and Interventional Cardiologist Opp. atulda@hotmail.com Vanita Vishram Ground, Athwagate, Ring Road, Surat , Surat Shree Mahavir Health Campus, Athwagate Ring Road Surat Surat Professor, Department of Cardiology St. John s Medical College Hospital, Sarjapur Road, Koramangala, Bangalore Bangalore KARNATAKA Sr. Consultant Cardiologist and Interventionalist Tagore Hospital and Heart Care Centre Pvt. Ltd., Banda Bahadur Nagar, Mahavir Marg, Jalandhar , Punjab, Jalandhar PUNJAB Director Cardiology Institute of Cardiovascular Diseases, The Madras Medical Mission Hospital, No. 4-A, Dr. J.Jayalalitha Nagar, drkiron@hotmail.com drnitishgarg@gmail.co m clireco@mmm.org.in page 5 / 10

6 Details of Ethics Committee Dr Raju Barathithasan Vinayaka Mission Hi-tech Hospital Mogappair, Sankari Main Road (NH 47) Salem Salem Dr T Shashikant Yashoda Hospital Cardiologist Yashoda Hospital, Alexander Road, Secunderabad Hyderabad ANDHRA PRADESH bthasan@yahoo.com sashikant17@yahoo.co. in Name of Committee Approval Status Date of Approval Is Independent Ethics Committee? Bankers Ethics Committee Central India Medical Research Ethics Committee Clinical Research and Ethics Committee, P.D.Hinduja National Hospital and Medical Research Center, Mumbai Ethical Review Board, Meenakshi Mission Hospital and Research Center, Madurai Ethics Commettiee, Vinayaka Mission Hi Tech Hospital Ethics Committee of Kovai Medical Center and Hospital Ethics Committee, Apollo Hospital, Hyderabad Ethics Committee, Kamalnayan Bajaj Hospital Approved 21/06/2012 No Approved 29/10/2012 No Approved 23/10/2012 No Approved 04/07/2012 No Approved 24/01/2013 No Approved 05/07/2012 No Approved 17/08/2012 No Approved 07/12/2012 No Ethics Committee, Life Approved 31/07/2012 No care Institute of Medical Science and Research Ethics Committee,Pune Medical Research Institute, Ruby Hall Clinic Ethics Committee-Caritas Hospital IEC of Deenanth Mangeshkar Hospital and Research Centre Approved 09/07/2012 No Approved 06/08/2012 No Approved 20/07/2012 No page 6 / 10

7 Independent Ethics Committee,Fortis Escorts Heart Institute, New Delhi Institute Ethics Committee,Fortis Escorts Hospital, Punjab Committe, Madras Medical Mission, Committee Departmant Of Cardiology, Lisie Hospital Committee Fortis Escorts Hospital, Jaipur Committee of Care Hospital, Hyderabad Committee, Apollo hospital, Committee, GKNM Hospital institutional Ethics Committee, NIMS, Committee,Fortis Hospital, Mohali KIMS Institutional Ethics Committee, Secunderabad Kota Committee Medanta Independent Ethics Committee Research Independent Ethics Committee Research Independent Ethics Committee, BD Mehta Hospital St. Johns Medical College IERB Sujilam Independent Ethics Committee Tagore Hospital and Heart Care Centre Ethics Committee The Bandra Holy Family Medical Research Society Approved 04/08/2012 No Approved 09/10/2012 No Approved 20/07/2012 No Approved 17/07/2012 No Approved 26/07/2012 No Approved 01/07/2012 No Approved 20/06/2012 No Approved 03/11/2012 No Approved 10/08/2012 No Approved 01/08/2012 No Approved 09/07/2012 No Approved 12/10/2012 No Approved 28/08/2012 No Approved 23/01/2013 No Approved 03/09/2012 No Approved 14/08/2012 No Approved 15/09/2012 Yes Approved 20/07/2012 No Approved 21/07/2012 No The Heart First Ethics Approved 29/06/2012 No page 7 / 10

8 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Committee YAMER, Yashoda Approved 25/07/2012 No Hospital, Secunderabad Status Not Applicable Health Type Patients Date No Date Specified Condition Coronory Heart Disease Type Name Details Intervention The PROMUS Element stent Intervention - The PROMUS Element stent is a stent with a drug/polymer coating. The coating comprises two layers. The inner layer consists of a polymer that is a primer for improving the adhesion of the outer layer; the outer layer is a polymer matrix that contains an active pharmaceutical ingredient. PROMUS Element comprises the following key components: 1. Everolimus 2. Two polymers 3. The Element stent component The PROMUS Element stent component has a smaller tip profile than the Express and Liberté stents, which is intended to enhance the ability to cross tighter and/or more complex lesions. Comparator Agent Not Applicable Not Applicable Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria CI1. Patients receiving PROMUS Element stents. Up to 3 Promus stents per patient 2 stents per artery CI2. Patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed. CI3. Patient is eligible for percutaneous coronary intervention (PCI) CI4. Patient is willing to comply with all protocol-required follow-up evaluations. Exclusion Criteria Details Exclusion Criteria CE1. Patient has known allergy to the study stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, chromium, nickel, iron, thienopyridines, aspirin, contrast) that cannot be adequately pre-medicated. CE2. Patient has any other serious medical illness (e.g., cancer, congestive heart failure - NYHA Class 3 and 4) that may reduce life expectancy to less than 12 months. CE3. Patients with a mixture of other drug eluting stents page 8 / 10

9 CE4. Pregnant and lactating females or females having positive pregnancy test (urine or serum) CE5. Known/ Suspected case of Human Immunodeficiency Virus Infection Method of Generating Random Sequence Method of Concealment Blinding/Masking Not Applicable Not Applicable Not Applicable Primary Outcome Outcome Timepoints Composite safety endpoint of Target Vessel Failure (TVF) rate Cardiac Death related to target vessel. Target Vessel Myocardial Infarction (TV-MI) Target Vessel Revascularization (TVR) Time point is 12 months post-index procedure Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial TVF rate (Time point is 30, 180 days, year 1 and year 2 TVR rate (Time point is 30, 180 days, year 1 and year 2 Target Lesion Revascularization (TLR) (Time point is 30, 180 days, year 1 and year 2 Composite of cardiac death or target vessel MI (Time point is 30, 180 days, year 1 and year 2 Composite of all deaths, all MI, all revascularizations Major Adverse Cardiac Events (MACE) which is the composite endpoint of cardiac death, all myocardial infarction, and TLR (Time point is 30, 180 days, year 1 and year 2 (Time point is 30, 180 days, year 1 and year 2 MI (Q-wave and non Q-wave) rate (Time point is 30, 180 days, year 1 and year 2 Cardiac death rate (Time point is 30, 180 days, year 1 and year 2 Non-cardiac death rate (Time point is 30, 180 days, year 1 and year 2 All death rate (Time point is 30, 180 days, year 1 and year 2 Cardiac death or MI rate (Time point is 30, 180 days, year 1 and year 2 All death or MI rate (Time point is 30, 180 days, year 1 and year 2 Stent thrombosis rate (definite or probable by Academic Research Consortium [ARC] definitions) Total Sample Size=1000 Sample Size from India=1000 Post Marketing Surveillance 18/07/2012 No Date Specified Years=3 Months=0 (Time point is 30, 180 days, year 1 and year 2 page 9 / 10

10 Powered by TCPDF ( PDF of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary Days=0 Not Applicable Completed None As Yet PROMUS Element India Registry is a prospective, multi-center registry to assess the PROMUS Element in a consecutive population of Indian patients with coronary artery disease undergoing coronary revascularization. Approximately 1,000 patients meeting inclusion and exclusion criteria will be enrolled at up to 50 clinical sites, to demonstrate the safety and effectiveness of PROMUS Element in an unrestricted Indian population. page 10 / 10