Coronary Artery Disease
Conditions
Keywords
BioResorbable Vascular Scaffold System
Brief summary
This is a Multi Center Randomized Control Study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in treatment of approximately 484 subjects with Coronary Artery Disease in China. Eligible subjects shall have up to two de novo lesions in different epicardial vessels (One lesion in each coronary artery or it's major branch),Target lesion shall have visually estimated diameter stenosis ≥ 70% (or ≥ 50% and has clinical evidence of myocardial ischemia), lesion length ≤ 24mm, reference vascular diameter visually ≥ 2.75mm and ≤ 4.0mm. And subjects must meet all the study inclusion / exclusion criteria before enrolment in the study.All subjects shall accept clinical follow up at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post procedure.
Detailed description
This is a Multi Center Randomized (MeRes:XIENCE=1:1) Control Study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in treatment of approximately 484 subjects with Coronary Artery Disease in China. The post marketed XIENCE Everolimus Eluting Coronary Stent System will serve as the control device, to evaluate the safety and efficacy of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in coronary artery disease, and to support the product registration approval of the China Food and Drug Administration (CFDA). Eligible subjects shall have up to two de novo lesions in different epicardial vessels ( One lesion in each coronary artery or it's major branch),Target lesion shall have visually estimated diameter stenosis ≥ 70% (or ≥ 50% and has clinical evidence of myocardial ischemia), lesion length ≤ 24mm, reference vascular diameter visually ≥ 2.75mm and ≤ 4.0mm. And subjects must meet all the study inclusion / exclusion criteria before enrolment in the study. All the subjects shall accept angiography follow up at 12 months post procedure. OCT subgroup ((N=80, 40 from test group and 40 from control group) shall accept follow up of OCT at immediately and 12 months post procedure. In segment late lumen loss at 12 months post procedure is the primary endpoint, and the percentage of stent strut neointimal coverage assessed with OCT at 12 months post procedure is the key secondary endpoint.
Interventions
DEVICEMeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System
MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System used in the treatment of patients with coronary artery disease along with standard percutaneous angioplasty procedure.
DEVICEXience EES Everolimus Eluting Coronary Stent System
Xience EES Everolimus Eluting Coronary Stent System indicated for the treatment of coronary artery disease along with standard percutaneous angioplasty procedure.
Sponsors
Meril Life Sciences Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 Randomization of Study Device and Control
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* General inclusion criteria: 1. Age ≥ 18 and ≤75years old, man or non-pregnant or non-lactating woman. 2. Subjects with asymptomatic ischemic evidence, stable or unstable angina, or old myocardial infarction \>7 days, suitable for selective PCI. Subjects without contraindications of coronary artery bypass grafting. 3. Subjects be able to understand the purpose of this study, volunteer to participate and sign informed consent, willing to accept invasive imaging follow-up. 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. Target lesion diameter stenosis ≥ 70% (or ≥ 50% simultaneously shall have clinical evidence of myocardial ischemia), and TIMI flow grade ≥1. 3. Target lesion length ≤ 24mm (estimated visually); reference vessel diameter between ≥ 2.75 mm to ≤ 4.00 mm. 4. Each target lesion can be fully covered by one scaffold.
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-segment Late Lumen Loss | 12 Months | Angiographic analysis for measuring Late Lumen Loss in both the treatment group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of stent strut neointimal coverage assessed with OCT | 12 Months | OCT analysis will be done to identify percentage of Neointimal coverage |
Contacts
Primary ContactImrankhan M Lohani, M.Sc.
Backup ContactAshok Thakkar, Ph.D
Outcome results
None listed