CTRI/2021/08/035665 [Registered on: 13/08/2021] Trial Registered Prospectively
Last Modified On:
15/03/2022
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Medical Device
Study Design
Randomized, Parallel Group Trial
Public Title of Study
MeRethon RCT
Scientific Title of Study
A prospective, open-label, multicentre, randomized, non-inferiority clinical trial
to compare the safety and performance of MeRes100 Sirolimus-eluting BioResorbable Vascular
Scaffold System versus Contemporary DES platforms in patients with de novo coronary artery
lesions.
Trial Acronym
MeRes100â„¢ Sirolimus-eluting BRS
Secondary IDs if Any
Secondary ID
Identifier
MLS/MER/MeRethon RCT Version 1.0.0 dated 18-March-2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ashok Thakkar
Designation
Head of the Department - Clinical Research and Medical Writing
Affiliation
Meril Life Sciences Pvt. Ltd.
Address
Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala Vapi
Valsad GUJARAT 396191 India
Phone
9879443584
Fax
Email
ashok.thakkar@merillife.com
Details of Contact Person Scientific Query
Name
Dr Ashok Thakkar
Designation
Head of the Department - Clinical Research and Medical Writing
Affiliation
Meril Life Sciences Pvt. Ltd.
Address
Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala Vapi
Valsad GUJARAT 396191 India
Phone
9879443584
Fax
Email
ashok.thakkar@merillife.com
Details of Contact Person Public Query
Name
Dr Ashok Thakkar
Designation
Head of the Department - Clinical Research and Medical Writing
Affiliation
Meril Life Sciences Pvt. Ltd.
Address
Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala Vapi
Valsad GUJARAT 396191 India
Phone
9879443584
Fax
Email
ashok.thakkar@merillife.com
Source of Monetary or Material Support
Meril Life Sciences Pvt. Ltd. Bilakhia House, Survey No. 135/139,
Muktanand Marg, Chala Vapi – 396191,
Gujarat, India.
Primary Sponsor
Name
Meril Life Sciences Pvt Ltd
Address
Bilakhia House, Survey No. 135/139,
Muktanand Marg, Chala Vapi – 396191,
Gujarat, India.
Type of Sponsor
Other [Medical Device Company]
Details of Secondary Sponsor
Name
Address
NIL
Countries of Recruitment
Bulgaria Croatia Denmark France Hungary India Indonesia Italy Latvia Netherlands Romania Serbia Slovakia Spain Sweden Ukraine
Clinical Research Ethics Committee, Medica Superspecialty Hospital, Kolkata
Approved
Drug Trial Ethics Committee, Dayanand Medical College and Hospital
Approved
FORTIS HEALTHCARE LIMITED, FORTIS ESCORTS HEART INSTITUTE, OKHLA ROAD, NEW DELHI, INDIA
Submittted/Under Review
Institutional Ethic Committee,GKNM Hospital
Approved
INSTITUTIONAL ETHICS COMMITTEE THE MADRAS MEDICAL MISSION
Submittted/Under Review
INSTITUTIONAL ETHICS COMMITTEE, AAYUSH HOSPITAL
Submittted/Under Review
INSTITUTIONAL ETHICS COMMITTEE-BIOMEDICAL RESEARCH (IEC-BMR)
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Notified
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
Comparator Agent
BioMime/Metafor/Proficient family SES
BioMime/Metafor/Proficient family Sirolimus-eluting Coronary Stent System
Intervention
MeRes100â„¢ BRS
The MeRes100â„¢ Sirolimus-eluting BioResorbable Vascular Scaffold System (BRS) is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to de novo lesion in native coronary arteries in patients eligible for percutaneous transluminal coronary angioplasty and scaffolding procedures.
Comparator Agent
Resolute ZES
Resolute Zotarolimus-eluting Coronary Stent System
Comparator Agent
Synergy EES
Synergy Everolimus-eluting Coronary Stent System
Comparator Agent
XIENCE family EES
XIENCE family Everolimus-eluting Coronary Stent System
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
General Inclusion Criteria:
1. Male or female patient ≥18 years of age
2. Subject who has provided written informed consent
3. Subject must agree to undergo all clinical investigations and follow-up visits as per protocol
4. Subject with documented myocardial ischemia (e.g., stable, unstable angina, or silent ischemia) and who are eligible candidates for elective percutaneous coronary intervention (PCI)
5. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure. This includes clinical trials of medications and/or invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed
Angiographic Inclusion Criteria:
1. One de novo target lesion or up-to two de novo target lesions in different epicardial vessels: Different epicardial vessels are defined as left anterior descending artery (LAD) and its branches, left circumflex artery (LCX) arteries and its branches, and right coronary arteries (RCA) and its branches. Thus, for example, the subject must not have two target lesions required to be treated at the LAD and its branches at the same time
2. Each target lesion can be fully covered by one scaffold
3. Target lesion with angiographic evidence of ≥70% stenosis (by visual estimation) and ≥50% (by QCA estimation) with TIMI flow of ≥1. If the target lesion is <70% stenosed, there must be an evidence of ischemia as per ECG or nuclear scan or fractional flow reserve (FFR)
4. Target lesion(s) located in native coronary artery with reference vessel diameter (RVD) of ≥2.75 mm to ≤4.0 mm and length ≤34 mm by QCA or by visual estimation
ExclusionCriteria
Details
General Exclusion Criteria:
1. Known hypersensitivity or contraindication to aspirin, both heparin and
bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel, ticlopidine inclusive), everolimus, sirolimus or its analog or derivative, poly (L-lactide), poly (DL-lactide), cobalt, PLGA [poly(DL-lactide-co-glycolide)], chromium, nickel, tungsten, stainless steel, platinum, platinum-chromium alloy, iron, molybdenum, amorphous silicon carbide, acrylic and fluoropolymers or contrast sensitivity that cannot be adequately pre-medicated
2. Any PCI <6 months prior to the index procedure
3. Previous CABG or PCI in the target vessel(s)
4. Left ventricular ejection fraction (LVEF) <30% as evaluated by any non-invasive imaging method including but not limited to, echocardiogram, angiography, Magnetic Resonance Imaging (MRI), Multiple-Gated Acquisition (MUGA) scan, radionuclide ventriculography, Positron Emission Tomography (PET) scan, etc. For subjects with stable Coronary Artery Disease (CAD), LVEF may be obtained within 6 months prior to the procedure. For Acute coronary syndrome (ACS) subjects, LVEF must be
evaluated during hospitalization or during index procedure but prior to randomization for confirming the subject’s eligibility
5. Concurrent medical condition with less than three years of life expectancy
6. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months of baseline visit
7. Renal insufficiency as estimated by Glomerular Filtration Rate (GFR) <30 ml/min/1.73m2 or dialysis at the time of screening or creatinine level is more than 1.5 mg/dl
8. Subject with cardiac arrhythmia detected at the time of screening
9. Subject is on immunosuppressant therapy and has immunosuppressive or autoimmune disease
10. Subject with hepatic disorder or chronic liver disease, known aplastic anaemia, platelet count <100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3
11. Subject with prior brachytherapy of the target lesion or use of
brachytherapy for the treated site restenosis
12. Subject has a history of bleeding diathesis or coagulatory disease, refuses
blood transfusion, significant gastrointestinal or urinary bleed within the past 12 months
13. Subject who underwent or needs organ transplant
14. Planned PCI for any clinically significant lesion after index procedure
15. Planned surgery within 12 months after index procedure
16. Pregnant or nursing subject and those who plan pregnancy in the period until 5 years following index procedure (Female subject of child-bearing potential must have a negative pregnancy test done within 7 days prior to
the index procedure and contraception must be used during participation in this trial)
17. Any newly onset acute myocardial infarction within 1 week (<7days) or, myocardial enzyme has not returned to normal level (clinically non-significant) after myocardial infarction
18. Subject with significant peripheral vascular disease that precludes safe access to sheath or catheter
Angiographic Exclusion Criteria:
1. Target lesion located within 3 mm of the origin of the LAD or LCx
2. Target lesion involving a bifurcation lesion with side branch ≥2 mm in diameter
3. Highly calcified lesions
Classification of calcification: moderate calcification - discontinuous dotted high density image; severe calcification - continuous high density image around the whole vessel wall under continuous X-ray by multiple positions
4. Target lesion which prevents complete balloon pre-dilatation, defined as
full balloon expansion with the following outcomes:
a. Residual % Diameter Stenosis (DS) is < 40% (per visual estimation), (≤ 20% is strongly recommended)
b. TIMI Grade-3 flow (per visual estimation)
c. No angiographic complications (e.g., no-reflow, distal embolization, side branch closure)
d. No dissections NHLBI grade D-F
e. No chest pain lasting > 5 minutes
f. No ST depression or elevation lasting > 5 minutes
5. Total occlusion (TIMI flow 0), prior to wire crossing
6. Excessive tortuosity (≥ two 45° angles), or extreme angulation (≥90°) proximal to or within the target lesion
7. Lesion is located in left main coronary artery
8. Thrombus in the target vessel determined by angiography or OCT
9. Subject with three-vessel disease where all three vessels require intervention
10. Additional lesion in same coronary vessel which requires treatment
11. Evidence of previous revascularization:
- Previous PCI with or without restenosis from previous intervention
- Arterial or venous graft with or without lesion located within the graft or distal to a diseased arterial or saphenous vein graft
Note: Lesions within 3 mm of the origin of the right coronary artery may be treated
Method of Generating Random Sequence
Permuted block randomization, variable
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Target lesion failure
Time frame: 1 year
Secondary Outcome
Outcome
TimePoints
Target Lesion Failure
[Time Frame: 30 days, 6 months, 2 years, 3 years,
4 years and 5 years]
Cardiovascular Death
[Time Frame: 30 days, 6 months, 1 year, 2 years, 3
years, 4 years and 5 years]
Target Vessel Myocardial Infarction
[Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years]
Clinically Driven Target Lesion Revascularization
[Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years]
Target Vessel Failure (TVF)
[Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years]
Target Vessel Revascularization (TVR)
[Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years]
Scaffold/Stent Thrombosis Rate
[Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years]
Device Success
[Time Frame: At index procedure]
Procedure Success
[Time Frame: Till discharge]
Quality of Life (QoL)
[Time Frame: Baseline, 30 days and 1 year]
Quantitative Coronary Angiography (QCA) Subset
[Time Frame: Post-procedure, 1 year, 3 years and 5 years]
Optical Coherence Tomography (OCT) Subset
[Time Frame: Post-procedure, 1 year, 3 years and 5 years]
Target Sample Size
Total Sample Size="1872" Sample Size from India="1123" 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, multicentre, randomized, non-inferiority clinical trial to compare the safety and performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System versus Contemporary drug-eluting stent platforms in patients with de novo coronary artery lesions at 60 investigational sites globally (including India).
The primary objective of this study is to evaluate safety and performance of MeRes100 BRS in comparison with XIENCE family EES/Resolute ZES/Synergy EES/BioMime/Metafor/Proficient family SES in patients with de novo coronary artery lesions with reference vessel diameter of ≥2.75 mm to ≤4.0 mm and lesion length ≤34 mm.
The MeRes100â„¢ BRS (Meril Life Sciences Pvt. Ltd., India) is a novel thin-strut second-generation sirolimus-eluting poly-L-lactic acid (PLLA)-based bioresorbable coronary scaffold is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to de novo lesion in native coronary arteries in patients eligible for percutaneous transluminal coronary angioplasty and scaffolding procedures.
After informed consent provided by the subject and confirmation of eligibility criteria and diagnostic angiography, subject will be randomized (2:1) to MeRes100 BRS or Contemporary DES using centralized web-based system.
Subject’s Clinical/Telephonic Follow-up will be taken at [Time Frame: 30 days (± 7 days) clinical follow-up, 6 month (± 28 days) clinical follow-up, 1 year (± 28 days) clinical follow-up, 2 years (± 28 days) telephonic follow-up, 3 years (± 28 days) clinical follow-up, 4 years (± 28 days) telephonic follow-up and 5 years (± 28 days) clinical follow-up]