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
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
Registry
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Ashok Seth
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 Contact Person Scientific Query
Name
Dr Ashok Seth
Address
Okhla Road,
New Delhi.
South DELHI 110 025 India
Phone
9810025814
Fax
011-26825012
Email
ashok.seth@fortishealthcare.com
Details Contact Person Public Query
Name
Prashant Janbandhu
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
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 Device Success as defined by achieving residual Diameter Stenosis less than 10% before
post dilatation.
36 Months
Acute procedure success as defined by achieving TIMI III grade flow by implantation of
device.
1,6,12,24 months
Cardiac deaths
1, 6, 12, 24 and 36 months.
Diameter Stenosis Percent,In-segment LL and In- treated area Late Loss
6 and 24 Months
In Stent and in segment Acute Gain
Post Procedure
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
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
Ischemia driven Target Vessel Revascularization
1, 6, 12, 24 and 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.
MI
1, 6, 12, 24 and 36 months
MSCT Endpoints:Vascular Area
and Scaffold area
12 months
Number of Dissections grade more than B, Residual Stenosis greater than 10%, TIMI flow less than TIMI-III flow
Post Procedure
OCT Endpoints:Mean Reference Vessel Diameter and minimum Lumen Diameter in target lesion
Pre
procedure, 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:Proportions of struts with complete and insufficient opposition to the vessel wall
Post Procedure,6 and 24 months
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
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.
Seth A, Onuma Y, Costa R, Chandra P, Bahl VK, Manjunath CN, Mahajan AU, Kumar V, Goel PK, Wander GS, Kalarickal MS. First-in-human evaluation of a novel poly-L-lactide based sirolimus-eluting bioresorbable vascular scaffold for the treatment of de novo native coronary artery lesions: MeRes-1 trial. EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2017 Jul;13(4):415-23.
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.
