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CTRI Number  CTRI/2015/04/005706 [Registered on: 20/04/2015] Trial Registered Prospectively
Last Modified On: 15/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Trial 
Public Title of Study   A Prospective, Multicenter, Single arm, Open label, Pilot Clinical Study of MeRes 100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in the Treatment of de-novo native Coronary Artery Lesions 
Scientific Title of Study   A Prospective, Multicenter, Single arm, Open label, Pilot Clinical Study of MeRes 100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in the Treatment of de-novo native Coronary Artery Lesions 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Ashok Seth 
Designation  Lead Investigator 
Affiliation  Fortis Escorts Heart Institute 
Address  Fortis Escorts Heart Institute, Department of Academics & Research, Room No - 23, Second Floor, RC Building, Residential Tower, Okhla Road, New Delhi.
Same as Earlier Mentioned
New Delhi
DELHI
110 025
India 
Phone  9810025814  
Fax  011-26825012  
Email  ashok.seth@fortishealthcare.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashok Seth 
Designation  Lead Investigator 
Affiliation  Escorts Heart Institute & Res. Centre 
Address  Okhla Road, New Delhi.

South
DELHI
110 025
India 
Phone  9810025814  
Fax  011-26825012  
Email  ashok.seth@fortishealthcare.com  
 
Details of Contact Person
Public Query
 
Name  Prashant Janbandhu 
Designation  Sr Clinical Research Associate 
Affiliation  Meril Life Science Pvt.Ltd. 
Address  Meril life Sciences Pvt.Ltd 612,Bonanza B wing, Sahar Plaza complex, Andheri kurla Road, Andheri East Mumbai-400059

Mumbai (Suburban)
MAHARASHTRA
400059
India 
Phone  9920938081  
Fax  022-40479717  
Email  prashant.janbandhu@merillife.com  
 
Source of Monetary or Material Support  
Meril Life Sciences Pvt Ltd Bilakhia Corporate House, Near GM Bilakhia Stadium, Muktanand Marg, Chala, Vapi - Gujarat-396191 India 
 
Primary Sponsor  
Name  Meril Life Sciences Pvt Ltd 
Address  Bilakhia Corporate House, Near GM Bilakhia Stadium, Muktanand Marg, Chala, Vapi - Gujarat-396191 India 
Type of Sponsor  Other [Medical Device] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 16  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr VK Bahl  All India Institute of Medical Sciences  New Delhi
New Delhi
DELHI 
9871053131

vkbahl@aiims.ac.in 
Dr P C Rath  Apollo Group of hospital  Hyderabad
Hyderabad
ANDHRA PRADESH 
09848024759

drpcrath@hotmail.com 
Dr Samuel Mathew K  Apollo Group of Hospitals  21 Greams Lane, Off Greams Road, CHENNAI
Chennai
TAMIL NADU 
09841071118

drmathew.sk@gmail.com 
Dr Anil Mishra  B M Birla Hospital  Kolkata
Kolkata
WEST BENGAL 
03330403266

dranilmishra@gmail.com 
Dr Ashok Seth  Escorts Heart Institute & Res. Centre  Okhla Road, NEW DELHI - 110 025
New Delhi
DELHI 
9810025814
01126825012
ashok.seth@fortishealthcare.com 
DrUpendra Kaul  Fortis Flt Lt Rajan Dhall Hospital  Sector B, Pocket 1, Aruna Asaf Ali Marg,Vasant Kunj, New Delhi, Delhi 110070
New Delhi
DELHI 
9811150518

kaul.upendra@gmail.com 
Dr Vijay K Trehan  Govind Ballabh Pant institute of Postgraduate Medical Education &Resarch  1, Jawaharlal Nehru Marg, New Delhi, Delhi 110002
New Delhi
DELHI 
9891225622

trehanvs@yahoo.co.in 
Dr GS Wander  Hero DMC Heart Institute  Civil Lines, LUDHIANA
Ludhiana
PUNJAB 
09815545316
01612304289
drgswander@yahoo.com 
Dr CN Manjunath  Jayadeva Institute of Cardiovascular Sciences & Research  Jayanagar, 9th Block, Bannerghatta Road, BENGALURU-560 069
Bangalore
KARNATAKA 
09844006689
08026534477
cnmanjunath@vsnl.et 
Dr Mahajan  Lokmanya Tilak Medical College  Mumbai
Mumbai
MAHARASHTRA 
9869032639

draumahajan@gmail.com 
DrViveka Kumar  Max Super Speciality Hospital  1,2, Press Enclave Road, Saket, New Delhi, Delhi 110017
New Delhi
DELHI 
9871001190

viveka.kumar@maxhealthcare.com 
Dr Praveen Chandra  Medanta Medicity   Sector 38 ,Gurgaon
South West
DELHI 
911244141414

info@medanta.org 
Dr Gaurav Ganeshwala  Ruby Hall Clinic  Pune
Pune
MAHARASHTRA 
918805054477

gauravmg@hotmail.com 
Dr P K Goyal  Sanjay Gandhi Post Graduate Institute of Medical Sciences   Raebareli Road ,-226 014
Lucknow
UTTAR PRADESH 
05222668004

drpkgoyal@hotmail.com 
Dr Ajith Kumar  Srichitra Medical Institute  Trivendrum
Thiruvananthapuram
KERALA 
04712446196

ajit@sctimst.ac.in 
Dr Sunitha  Trivandrum Medical College  Thiruvananthapuram
Thiruvananthapuram
KERALA 
09447737403

sunitavishwan@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
Ethics Committee for Research Fortis Flt. Rajan Dhall Hosptial  Approved 
Institutional Ethics Committee Max Super Specialty Hospital  Approved 
Medanta institutional ehics comitttee Medanta-The Medicity  Approved 
Ethic committee- of Apollo Hospitals,Apollo Group of Hospitals, 21 Greams Lane, Off Greams Road, Chennaii  Approved 
AIIMS Delhi  Approved 
EC of Trivandrum Medical Collage  Submittted/Under Review 
Ethic committee- of Apollo Hospitals,(Apollo health city) Jubilee Hills Hyderabad  Approved 
Ethics committee -Poona Medical Research foundation  Approved 
Ethics Committee of Dayanand Medical collage & Hospital Unit,Hero DMC Heart Institute  Approved 
Ethics Commmittee Sree Jayadeva Institute of cardiovascular science and research  Approved 
Independent ethics committee of Fortis Escorts Heart Institute & Research Centre  Approved 
Institute Ethics Committee of Sree Chitra Tirunal Institute for Medical Science and Technology, Trivandrum   Approved 
institutional Ethics Committee -Human resource Lokmanya Tilak Municipal Medical College  Approved 
Institutional Ethics Committee of B.M.Birla Heart research Centre  Approved 
Institutional Ethics Committee Sanjay Gandhi Postgraduate Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  I251||Atherosclerotic heart disease of native coronary artery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Sirolimus Eluting Bioresorbable Vascular Scaffold System (BVS)  Treatment(Per-cutaneous Coronary intervention) of de-novo native coronary artery lesions.”with Sirolimus Eluting Bioresorbable Vascular Scaffold System (BVS)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  General Inclusion Criteria:
1. Subjects between 18 – 65 years of age.
2. Subject is able to sign written informed
consent form.
3. Subjects with symptomatic Myocardial
Ischemia, Chronic Stable Angina.
4. The patient has planned intervention of a
single de novo lesion in native epicardial vessel.
5. Subject who is an acceptable candidate for
CABG.
6. Subject willing not to participate in any other
clinical investigation for a period of 3 years
following the index procedure.
Angiographic Inclusion Criteria:
1. Subject with maximum two treatable de novo
lesions located maximum one per native
epicardial vessel located in major artery or
branch, with Reference vessel Diameter
between 2.5 and 3.5 mm by on line QCA.
2. Target lesion length between 17 and 27 mm.
3. Subjects with Lesion(s), with a visually
estimated stenosis of ≥ 50% and <100% with a
TIMI flow of ≥ 1. 
 
ExclusionCriteria 
Details  General Exclusion Criteria:
1. Subjects unable to provide written informed consent.
2. Pregnant or nursing mother and those who plan pregnancy during the clinical investigation (Female patients must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraceptive must be used during participation in this Clinical Investigation).
3. Subjects with known allergy to Poly-lactic Acid, PLLA, PDLG, Nitinol, Contrast media, and any drug in dual antiplatelet therapy including aspirin, both heparin and bivalirudin etc.
4. Subject diagnosed with acute MI (AMI) within 7 days preceding the index procedure, as indicated by elevated levels of Cardiac Enzymes and/or ST
segment changes in ECG.
5. Subject with history of previous revascularization procedures including CABG and PCI.
6. Subject with vascular aneurysms, Cardiac arrhythmias, Congestive Cardiac Failure having LVEF < 30%, Cardiac tamponade.
7. Recipient of an organ in an organ transplant procedure or is on a waiting list for any organ transplant.
8. Subjects receiving immunosuppression therapy or having known immunosuppressive or autoimmune disease.
9. Subjects with history of stroke,cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA), renal insufficiency where creatinine levels are more than 1.3 mg/dl, known aplastic anemia, chronic liver disease,platelet count <100,000 cells/mm3, a WBC of <3,000 cells/mm3.
10. Subjects planned for Elective surgery within the first 12 months after the procedure that will require discontinuing Dual antiplatelet therapy.
11. Subject has a history of bleeding diathesis or coagulatory or will refuse blood transfusion, significant GI or urinary bleed within the past 12 months.
12. Subject having extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
13. Subject having a history of paradoxical exercise induced vasoconstriction
that is consistent with myocardial bridging in the coronary anatomy.
14. Subjects participating in another clinical investigation
15. Subjects with short life expectancy such as Cancer, HIV / AIDS, or other comorbid conditions that would limit compliance with the follow-up schedule of the study.
Angiographic Exclusion Criteria:
1. Subjects who are non-candidates for PCI.
2. Any of the Target lesions meets any of the following criteria:
a) Aorto-ostial location (within 3 mm).
b) Lesion located in Left main Coronary Artery.
c) Lesion Located within 2 mm of origin of the LAD or LCX.
d) Lesion that Involves a bifurcation with a side branch ≥ 2mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch
requiring intervention.
e) Total occlusion (TIMI Flow 0), prior to wire crossing.
f) Extreme tortuosity proximal to or within the lesion
g) Lesions having Heavy calcification.
h) Extreme angulation (≥90%) proximal to or within the lesion.
3. Evidence of previous revascularization:
a) Previous PCI with or without Restenosis from previous intervention.
b) Arterial or venous graft with or without Lesion Located within the graft or distal to a diseased arterial or saphenous vein graft.
4. The target vessel contains visible thrombus.
5. Another (clinically significant or potentially significant) lesion left untreated within target vessels (including side branch) or another significant vessel.
6. Subject requiring or potentially requiring other interventional procedures that pre-dilation and study device implantation and post dilatation. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Clinical endpoint:
1. Proportion of population reporting Major Adverse
Cardiac Events at 6 months from the day of index
Procedure.
Primary Safety Endpoints:
1. Proportion of Population with Ischemia Driven
MACE at 6 months from the date of Index procedure.
Primary Angiographic endpoint:
1. Late lumen loss at 6 months Predetermined
subgroup of 35% of the overall study population. 
6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Acute procedure success as defined by achieving TIMI III grade flow by implantation of
device. 
1,6,12,24 months 
Acute Device Success as defined by achieving residual Diameter Stenosis less than 10% before
post dilatation. 
36 Months 
Major Adverse Cardiac Events at defined as composite of Cardiac Deaths, Target Vessel
Revascularization and non-fatal Myocardial infarction  
1, 12, 24 and 36 months. 
Cardiac deaths  1, 6, 12, 24 and 36 months. 
MI  1, 6, 12, 24 and 36 months 
Target Vessel oriented MI (TV-MI)  1, 6, 12, 24 and 36 months 
Target Vessel Failure defined as hierarchical composite of Cardiac Deaths, Target vessel
Oriented MI and Target Vessel Revascularization  
1, 6, 12, 24 and 36 months 
Ischemia driven Target Vessel Revascularization  1, 6, 12, 24 and 36 months 
Ischemia driven and All Cause TLR  1,6,12,24 and 36 months 
Ischemia driven non Target Vessel Revascularization   1, 6, 12, 24 and 36 months 
Scaffold thrombosis   1, 6, 12, 24 and 36 months 
In Stent and in segment Acute Gain  Post Procedure 
Number of Dissections grade more than B, Residual Stenosis greater than 10%, TIMI flow less than TIMI-III flow  Post Procedure 
Diameter Stenosis Percent,In-segment LL and In- treated area Late Loss  6 and 24 Months 
In- treated area and In-segment % Diameter Stenosis (DS)
 
post-procedure, 6 and 24
months. 
In-treated area and In-segment Angiographic Binary Restenosis (ABR) rate,Aneurysm, thrombus, persisting dissection  6 and 24 months 
OCT Endpoints:Proportions of struts with complete and insufficient opposition to the vessel wall  Post Procedure,6 and 24 months 
OCT Endpoints:Proportions of struts covered and remaining uncovered,Proportion of struts with persisting analyzable incomplete opposition from baseline,Number and proportion of struts with late incomplete opposition  6 and 24 montths 
OCT Endpoints:Vessel area,Analyzable Scaffold area,Lumen area,Minimum, Luminal Area (MLA),Mean Volume obstruction in treated area and segment,Mean Lumen Area in treated area and segment  Post procedure,6 and 24 months. 
OCT Endpoints:Vessel wall thickness and neo-intimal thickness,Treated Site % Volume Obstruction (VO)  6 and 24 months 
OCT Endpoints:Mean Reference Vessel Diameter and minimum Lumen Diameter in target lesion  Pre
procedure, Post procedure, 6 and 24 months. 
MSCT Endpoints:Vascular Area
and Scaffold area 
12 months 
PK Study End Points:Time taken to reach to maximum concentration (Tmax) level in blood after implantation of the
stent.
1. Maximum concentration of the drug obtained in peripheral venous blood (CMax).
2. Mean Initial (T½i) and Terminal (T½T) half life period of the drug in venous blood.
3. Area Under Curve (AUC) of the blood drug concentration.
4. Time taken for drug to go below detectable levels in venous blood sample by LCMSMS
method. 
0 min, 30 min., 1, 3, 6, 12, 24 hrs, & 7, 14,
28, 90 days 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   04/05/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Brief Summary  
This is a prospective, multicenter, Historical control single arm, open label Pilot Clinical Study of MeRes™ Sirolimus Eluting Bioresorbable Vascular Scaffold System (BVS) in the treatment of de-novo native coronary artery lesions.108 subjects will be enrolled from the centers located in all parts of India. Primary outcome of study will be Proportion of population reporting Major Advserse Cardiac Events at 6 months from the day of index Procedure.
 
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