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. Subject's Clinical/Telephonic Follow-up will be taken at \[Time Frame: 30 days (± 7 days) clinical follow-up, 6 month (± 28 days) clinical follow-up, 1 year (± 28 days) clinical follow-up, 2 years (± 28 days) telephonic follow-up, 3 years (± 28 days) clinical follow-up, 4 years (± 28 days) telephonic follow-up and 5 years (± 28 days) clinical follow-up\]
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 MeRes100™ 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 \[Time Frame: 30 days (± 7 days) clinical follow-up, 6 month (± 28 days) clinical follow-up, 1 year (± 28 days) clinical follow-up, 2 years (± 28 days) telephonic follow-up, 3 years (± 28 days) clinical follow-up, 4 years (± 28 days) telephonic follow-up and 5 years (± 28 days) clinical follow-up\]
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
The MeRes100™ 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. The first-in-human MeRes-1 trial demonstrated the safety and effectiveness of MeRes100 BRS in the treatment of de novo coronary lesions with lower major adverse cardiac events (MACE) rate (0.93%) and notably, the absence of scaffold thrombosis at one-year follow-up. MeRes100 sirolimus-eluting bioresorbable vascular scaffold system is expected to bioresorb in the artery, approximately over a period of three years and thus, preventing chance of late clinical events like late scaffold thrombosis rates. The imaging analysis has shown that in-segment late lumen loss and in-scaffold late lumen loss (LLL) did not change significantly at two years follow-up as compared to six months data.
Target Lesion Failure (TLF)
It is a composite of cardiovascular death, target vessel myocardial infarction (TVMI) and clinically driven target lesion revascularization (CD TLR).
Time frame: 1 year
Target Lesion Failure (TLF)
It is a composite of cardiovascular death, target vessel myocardial infarction and clinically driven target lesion revascularization
Time frame: 30 days, 6 months, 2 years, 3 years, 4 years and 5 years
Cardiovascular Death
Defined as per the ARC-2 criteria The following categories will be collected: * Death caused by acute MI * Death caused by sudden cardiac arrest, including unwitnessed death * Death resulting from heart failure * Death caused by stroke * Death caused by cardiovascular procedures * Death resulting from cardiovascular hemorrhage * Death resulting from other cardiovascular cause.
Time frame: 30 days, 6 months, 2 years, 3 years, 4 years and 5 years
Target Vessel Myocardial Infarction
* MI related to the target vessel is defined as TVMI * MI is defined as per the fourth universal definitions of MI
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Clinically Driven Target Lesion Revascularization
-It is defined as repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion with following additional criteria hierarchically: 1. Core laboratory-reported fractional flow reserve ≤0.80 or instant wave-free ratio ≤0.89 2. Site-reported fractional flow reserve ≤0.80 or instant wave-free ratio ≤0.89 3. Quantitative coronary analysis diameter stenosis \>50% (based on the average of multiple views) with either recurrent symptoms or positive non-invasive functional test 4. Quantitative coronary analysis diameter stenosis \>70% (based on the average of multiple views) regardless of other criteria 5. Quantitative coronary analysis diameter stenosis \>70% (based on the worst view) regardless of other criteria
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Target Vessel Failure
It is defined as the composite of cardiovascular death, target vessel myocardial infarction, and target vessel revascularization
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Target Vessel Revascularization
It is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel, including the target lesion revascularization
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Scaffold/Stent Thrombosis Rate
It is defined as per ARC-2 criteria
Time frame: : 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Device Success
It is defined as successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual diameter stenosis \<30% of all treated lesions as assessed by visual inspection or quantitative coronary angiography and TIMI 3 flow grade of the treated vessel
Time frame: From the start of Index Procedure till 5 years follow ups subsequently
Procedure Success
It is defined as successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual diameter stenosis \<30% of all treated lesions as assessed by visual inspection or quantitative coronary angiography and TIMI 3 flow grade of the treated vessel for all target lesions without the occurrence of cardiovascular death, target vessel MI or repeat TLR during the hospital stay
Time frame: From the start of Index Procedure till 5 years follow ups subsequently
Quality of Life Short Form Survey (SF-12)
Overall Health Status assessed by Short Form Survey (SF-12)
Time frame: Baseline, 30 days and 1 year
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