Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, MeRes-1 Extend, MeRes100, Sirolimus Eluting Bioresorbable Vascular Scaffold System
Brief summary
MeRes-1 Extend study is designed as prospective, multinational, multicentre, single arm, open label, pilot study to assess the safety and performance of the MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System (BRS) in subjects with de novo native coronary artery lesions. 64 subjects will be enrolled from the 8 centers located in Asia Pacific, Europe, Brazil and South Africa. Primary outcome of study will be Proportion of population reporting Major Adverse Cardiac Events at 6 months from the day of index Procedure.
Interventions
DEVICEMeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System
MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in the treatment of de-novo coronary artery lesions.
Sponsors
Meril Life Sciences Pvt. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single intervention with MeRes100 Device
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: 1. Male or female subjects ≥ 18 years of age 2. Subject is able to sign written Informed Consent Form (ICF) 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 Coronary Artery Bypass Grafting (CABG) 6. Subject is not participating in any other clinical investigation/study and agrees not to participate in any other clinical investigation/study for a period of 3 years following the index procedure. 7. Subject must agree to undergo all clinical investigation plan-required follow-up visits, angiograms and OCT as per protocol. 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 2.75, 3.00 and 3.5 mm by on line QCA. 2. Target lesion length ≤ 20 mm. 3. Subjects with Lesion(s), with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 1.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Clinical Endpoint: Proportion of population reporting with Major Adverse Cardiac Event at 6 months from the day of index procedure. | 6 Month |
| Primary Safety Endpoint: Proportion of population reporting with Ischemia Driven Major Adverse Cardiac Event (ID MACE) reporting at 6 months (180 days) from the day of index procedure | 6 Month |
Countries
Brazil, Indonesia, Malaysia, North Macedonia
Outcome results
None listed