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

Phase 2/3

Completed

Conditions: Atherosclerotic heart disease of native coronary artery,

Registration Number: CTRI/2015/04/005706

Lead Sponsor: Meril Life Sciences Pvt Ltd

Brief Summary: This is a prospective, multicenter, Historical control single arm, open label Pilot Clinical Study of MeResâ„¢ 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 108

Inclusion Criteria

General Inclusion Criteria: 1.
Subjects between 18 â€“ 65 years of age.
Subject is able to sign written informed consent form.
Subjects with symptomatic Myocardial Ischemia, Chronic Stable Angina.
The patient has planned intervention of a single de novo lesion in native epicardial vessel.
Subject who is an acceptable candidate for CABG.
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.
Target lesion length between 17 and 27 mm.
Subjects with Lesion(s), with a visually estimated stenosis of â‰¥ 50% and <100% with a TIMI flow of â‰¥ 1.

Exclusion Criteria

General Exclusion Criteria: 1.
Subjects unable to provide written informed consent.
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).
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.
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.
Subject with history of previous revascularization procedures including CABG and PCI.
Subject with vascular aneurysms, Cardiac arrhythmias, Congestive Cardiac Failure having LVEF < 30%, Cardiac tamponade.
Recipient of an organ in an organ transplant procedure or is on a waiting list for any organ transplant.
Subjects receiving immunosuppression therapy or having known immunosuppressive or autoimmune disease.
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.
Subjects planned for Elective surgery within the first 12 months after the procedure that will require discontinuing Dual antiplatelet therapy.
Subject has a history of bleeding diathesis or coagulatory or will refuse blood transfusion, significant GI or urinary bleed within the past 12 months.
Subject having extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
Subject having a history of paradoxical exercise induced vasoconstriction that is consistent with myocardial bridging in the coronary anatomy.
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.
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.
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 (â‰¥90%) proximal to or within the lesion.
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.
The target vessel contains visible thrombus.
Another (clinically significant or potentially significant) lesion left untreated within target vessels (including side branch) or another significant vessel.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Clinical endpoint:	6 Months
1. Proportion of population reporting Major Adverse	6 Months
Cardiac Events at 6 months from the day of index	6 Months
Procedure.	6 Months
Primary Safety Endpoints:	6 Months
1. Proportion of Population with Ischemia Driven	6 Months
MACE at 6 months from the date of Index procedure.	6 Months
Primary Angiographic endpoint:	6 Months
1. Late lumen loss at 6 months Predetermined	6 Months
subgroup of 35% of the overall study population.	6 Months

Secondary Outcome Measures

Name	Time	Method
Acute procedure success as defined by achieving TIMI III grade flow by implantation of	device.
Acute Device Success as defined by achieving residual Diameter Stenosis less than 10% before	post dilatation.
Major Adverse Cardiac Events at defined as composite of Cardiac Deaths, Target Vessel	Revascularization and non-fatal Myocardial infarction
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
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)
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
MSCT Endpoints:Vascular Area	and Scaffold area
PK Study End Points:Time taken to reach to maximum concentration (Tmax) level in blood after implantation of the	stent.

Trial Locations

Locations (16): All India Institute of Medical Sciences
🇮🇳
Delhi, DELHI, India
Apollo Group of hospital
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Hyderabad, ANDHRA PRADESH, India
Apollo Group of Hospitals
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Chennai, TAMIL NADU, India
B M Birla Hospital
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Kolkata, WEST BENGAL, India
Escorts Heart Institute & Res. Centre
🇮🇳
Delhi, DELHI, India
Fortis Flt Lt Rajan Dhall Hospital
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Delhi, DELHI, India
Govind Ballabh Pant institute of Postgraduate Medical Education &Resarch
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Delhi, DELHI, India
Hero DMC Heart Institute
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Ludhiana, PUNJAB, India
Jayadeva Institute of Cardiovascular Sciences & Research
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Bangalore, KARNATAKA, India
Lokmanya Tilak Medical College
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Mumbai, MAHARASHTRA, India
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All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr VK Bahl
Principal investigator
9871053131
vkbahl@aiims.ac.in