PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Fri, 01 Oct 2021 00:50:50 GMT) CTRI Number CTRI/2017/10/009968 [Registered on: 03/10/2017] - Trial Registered Retrospectively Last Modified On 24/12/2018 Post Graduate Thesis No Type of Trial Observational Type of Study retrospective study Study Design Other Public Title of Study To evaluate safety and performance of the BioMime™- Sirolimus Eluting Coronary Stent System in the treatment of patients during a pre-defined period. Scientific Title of A Retrospective study of consecutive patients treated with BioMime™ – Sirolimus Eluting Coronary Study Stent System during a pre-defined period. Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Rajendra Kumar Premchand Jain Trial Coordinator (multi-center study) Designation Principal Investigator Affiliation Krishna Institute of Medical Sciences Address Department of Cardiology, Krishna Institute of Medical Sciences, 1-8-31/1, Minister Road, Begumpet, Hyderabad-500 003, Andhra Pradesh, India Hyderabad ANDHRA PRADESH 500 003 India Phone Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Ashok Thakkar Query) Designation Head of Clinical Research Affiliation Meril Life Sciences Pvt Ltd Address Department of Clinical Resaerch, Meril Life Sciences Pvt Ltd, Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi Valsad GUJARAT 396191 India Phone 9879443584 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Ashok Thakkar Designation Head of Clinical Research Affiliation Meril Life Sciences PVT.LTD Address Meril Life Sciences Pvt. Ltd. Muktanand Marg, Chala, Vapi-396 191, Gujarat, India. Valsad GUJARAT 396 191 India page 1 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in Phone 91-260-3052100 Fax 91-260-3052125 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Meril Life Sciences Pvt Ltd, Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi-396191, Gujarat, India Primary Sponsor Primary Sponsor Details Name Meril Life Sciences Pvt Ltd Address Meril Life Sciences Pvt Ltd, Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi-396191, Gujarat, India Type of Sponsor Other [Medical Device Company] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr B V Manjunath A.J hospital and Bejai - Kavoor Road, 09845376444 research centre Kapikad, Kuntikana, NH-66, Mangaluru, [email protected] Karnataka 575004 Udupi KARNATAKA Dr Banker Darshan Bankers Heart Institute Near Tagorenagar Opp. 02652324004 Navinchandra Suryakiran Complex, Old Padra Road, [email protected] Vadodara 390 015 Gujarat - India Vadodara GUJARAT Dr Dharmesh Solanki Dhakaan Hospital Near Shri 02812456451 Ranchhoddasji Bapu Ashram Kuvadva Road, cardiac_consultants200 Rajkot, Gujarat 360003 [email protected] Rajkot GUJARAT Dr PK Ashokan Fatima Hospital Perumpadappu, Kochi, 04952766630 682 006 Ernakulam [email protected] KERALA Dr Narendra G.S.S. Hospital and G.S.S. Hospital and 918362358431 Hiregoudar Trauma Centre Trauma Centre, #28 and 30, Laxmi [email protected] Complex, 1st floor, m Near Traffic Island, Neeligin Road, Hubli - 580 029. Dharwad KARNATAKA Dr Gurpreet Singh HERO DMC Civil Lines, DMC Road, 01612304282 Wander Tagore nagar, Ludhiana, Punjab [email protected] 141001 m Ludhiana page 2 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in PUNJAB Dr Raghav Sharma Lalitha Super Specialty Lalitha Super Specialty 09440800355 Hospital Hospital, Gowrishanker Theatre Road, [email protected] Guntur-01. Guntur ANDHRA PRADESH Dr N Balakrishnan Lourdes Hospital Lourdes Hospital 048444125555 Ernakulam, Kochi - 682 012, Kerala, India [email protected] Ernakulam KERALA Dr SS Bansal Metro Heart Institute Sector 16A, Near 01294277777 Sunflag Hospital, Faridabad, Haryana Drbansal.metro@gmail. 121002 com Faridabad HARYANA Dr Aniruddha Shree Saibaba Heart Near Kalidas Kala 02532507001 Dharmadhikari Institute And Research Mandir, Shalimar, Centre Nashik, Maharashtra [email protected] 422001 Nashik MAHARASHTRA Dr CV Patil Shri Sai Cardiac Centre 2021/B, 6th Ln, 02312522892 Mahalaxminagar, Rajarampuri, Kolhapur, [email protected] Maharashtra 416008 om Kolhapur MAHARASHTRA Dr VP Sharma Shriram Cardiac Centre jpshi hospital premises 01815013220 Jalandhar PUNJAB drvp.sriramcentre@gm ail.com Dr Padhinhare P Westfort Hospital RB. No. 803, Westfort, 04872382130 Mohanan Thrissur, Kerala 680004 Thrissur [email protected] KERALA om Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Bankers Ethics Approved 31/01/2012 No Committee DYANAND MEDICAL Approved 20/04/2012 No COLLEGE & HOSPITAL LUDHIANA LALITHA SUPER Approved 19/01/2012 No SPECIALITIES HOSPITAL ETHICS COMMITTEE SSIEC Approved 14/01/2012 No SSIEC_BV Manjunath Approved 14/01/2012 No SSIEC_CV Patil Approved 14/01/2012 No SSIEC_Dharmesh Approved 14/01/2012 No SSIEC_N BalaK Approved 14/01/2012 No SSIEC_nh Approved 14/01/2012 No SSIEC_pkashokan Approved 14/01/2012 No page 3 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in SSIEC_ppmohanan Approved 14/01/2012 No SSIEC_ss bansal Approved 14/01/2012 No SSIEC_VP Sharma Approved 14/01/2012 No Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Chronic ischemic heart disease, unspecified Intervention / Type Name Details Comparator Agent Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 0.00 Year(s) Gender Both Details 1. Patient is 18 Year old.<br/> 2. Patients who have been implanted with BioMime™ – Sirolimus Eluting Coronary<br/> Stent System between January-2010 to February-2011.<br/> 3. The patient and/or his legal representative have provided a hospital written informed<br/> consent. Exclusion Criteria Exclusion Criteria Details 1. Patients who have not been implanted with BioMime™ – Sirolimus Eluting Coronary Stent System. 2. Patients who have been implanted with BioMime™ – Sirolimus Eluting Coronary Stent System before and after January-2010 to February-2011 Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints 1.month clinical/telephonic follow-up and 6 1 month, 6 months and 12 months months clinical/ telephonic follow-up. clinical/telephonic follow-up data will be recorded The secondary endpoint of this study is to in a pre-approved Case Report Form, and a evaluate the MACE events at 12 months clinical/ safety analysis report will be prepared based on telephonic follow-up. the above recorded parameters. For this study Major Adverse Cardiac Event (MACE) is defined as a composite of: 1. Death 2. Myocardial Infarction (MI) 3. Coronary Artery Bypass Graft (CABG) surgery 4. Target Lesion Revascularisation (TLR) 5. Target Vessel Revascularisation (TVR) and 6. Stent Thrombosis (ST) Secondary Outcome Outcome Timepoints The secondary endpoint of this study is to The secondary endpoint of this study is to evaluate the MACE events at 12 months clinical/ evaluate the MACE events at 12 months clinical/ telephonic follow-up. telephonic follow-up. Target Sample Size Total Sample Size=1161 Sample Size from India=1161 Final Enrollment numbers achieved (Total)=1161 Final Enrollment numbers achieved (India)=1161 Phase of Trial Post Marketing Surveillance page 4 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in Date of First 01/01/2010 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details Jain RK, Chakravarthi P, Shetty R, Ramchandra P, Polavarapu RS, Wander GS, Mohan B, Banker DN, Dharmadhikari A, Bansal SS, Jain N. One-year outcomes of a BioMime™ Sirolimus-Eluting Coronary Stent System with a biodegradable polymer in all-comers coronary artery disease patients: The meriT-3 study. Indian heart journal. 2016 Sep 1;68(5):599-603. Brief Summary meriT-3 is a retrospective study of consecutive patients treated with BioMime™ – Sirolimus Eluting Coronary Stent System during a pre-defined period. The objective of this study is to retrospectively analyse the safety parameters of the BioMime™ - Sirolimus Eluting Coronary Stent System that have been implanted in patients with Coronary Artery Disease and who have been treated consecutively at different centers within India. This is a non-randomized, retrospective, multi-center study. A series of patients with existing coronary artery disease and who have been implanted with BioMime™ – Sirolimus Eluting Coronary Stent System in a pre-determined period of time will be retrospectively included for analysis in this study. The patient’s baseline demographics, procedural details, hospital discharge details and the 1 month, 6 months and 12 months clinical/telephonic follow-up data will be recorded in a pre-approved Case Report Form, and a safety analysis report will be prepared based on the above recorded parameters. Inclusion Criteria: Patients must meet ALL of the following criteria: 1. Patient