Non-inferiority Clinical Trial to Compare the Safety and Performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System Versus Contemporary DES Platforms in Patients With de Novo Coronary Artery Lesions

NCT05417893 | Withdrawn DMC

• 1 other identifier: MLS/MER/MeRethon RCT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 \[Time Frame: 30 days (± 7 days) clinical follow-up, 6 month (± 28 days) clinical follow-up, 1 year (± 28 days) clinical follow-up, 2 years (± 28 days) telephonic follow-up, 3 years (± 28 days) clinical follow-up, 4 years (± 28 days) telephonic follow-up and 5 years (± 28 days) clinical follow-up\]

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure (TLF)

  It is a composite of cardiovascular death, target vessel myocardial infarction (TVMI) and clinically driven target lesion revascularization (CD TLR).

  1 year

Secondary Outcomes (10)

• Target Lesion Failure (TLF)

  30 days, 6 months, 2 years, 3 years, 4 years and 5 years

• Cardiovascular Death

  30 days, 6 months, 2 years, 3 years, 4 years and 5 years

• Target Vessel Myocardial Infarction

  30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years

• Clinically Driven Target Lesion Revascularization

  30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years

• Target Vessel Failure

  30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years

Study Arms (2)

Cohort-1: MeRes 100 BRS

ACTIVE COMPARATOR

1248 subjects will be delivered with MeRes 100 BRS

Device: MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS)

Cohort- 2: Contemporary DES platforms

ACTIVE COMPARATOR

624 subjects will be delivered with Contemporary DES

Device: MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS)

Interventions

MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS) DEVICE

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.

Also known as: XIENCE family Everolimus-eluting Coronary Stent System (EES), Resolute Zotarolimus-eluting Coronary Stent System (ZES), Synergy EES, BioMime/Metafor/Proficient family Sirolimus-eluting Coronary Stent System (SES)

Cohort- 2: Contemporary DES platforms; Cohort-1: MeRes 100 BRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject ≥18 years of age
• Subject who has provided written informed consent
• Subject must agree to undergo all clinical investigations and follow-up visits as per protocol
• Subject with documented myocardial ischemia (e.g. stable, unstable angina, or silent ischemia) and who are eligible candidates for elective percutaneous coronary intervention (PCI)
• Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure. This includes clinical trials of medications and/or invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed
• 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
• Each target lesion can be fully covered by one scaffold
• Target lesion with angiographic evidence of ≥70% stenosis (by visual estimation) and ≥50% (by QCA estimation) with TIMI flow of ≥1. If the target lesion is \<70% stenosed, there must be an evidence of ischemia as per ECG or nuclear scan or fractional flow reserve (FFR)
• Target lesion(s) located in native coronary artery with reference vessel diameter (RVD) of ≥2.75 mm to ≤4.0 mm and length ≤34 mm by QCA or by visual estimation

You may not qualify if:

• Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel, ticlopidine inclusive), everolimus, sirolimus or its analog or derivative, poly (L-lactide), poly (DL-lactide), cobalt, PLGA \[poly(DL-lactide-co-glycolide)\], chromium, nickel, tungsten, stainless steel, platinum, platinum-chromium alloy, iron, molybdenum, amorphous silicon carbide, acrylic and fluoropolymers or contrast sensitivity that cannot be adequately pre-medicated
• Any PCI \<6 months prior to the index procedure
• Previous CABG or PCI in the target vessel(s)
• Left ventricular ejection fraction (LVEF) \<30% as evaluated by any non-invasive imaging method including but not limited to, echocardiogram, angiography, Magnetic Resonance Imaging (MRI), Multiple-Gated Acquisition (MUGA) scan, radionuclide ventriculography, Positron Emission Tomography (PET) scan, etc. For subjects with stable Coronary Artery Disease (CAD), LVEF may be obtained within 6 months prior to the procedure. For Acute coronary syndrome (ACS) subjects, LVEF must be evaluated during hospitalization or during index procedure but prior to randomization for confirming the subject's eligibility.
• Concurrent medical condition with less than three years of life expectancy
• Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months of baseline visit
• Renal insufficiency as estimated by Glomerular Filtration Rate (GFR) \<30 ml/min/1.73m2 or dialysis at the time of screening or creatinine level is more than 1.5 mg/dl
• Subject with cardiac arrhythmia detected at the time of screening
• Subject is on immunosuppressant therapy and has immunosuppressive or autoimmune disease.
• Subject with hepatic disorder or chronic liver disease, known aplastic anaemia, platelet count \<100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3
• Subject with prior brachytherapy of the target lesion or use of brachytherapy for the treated site restenosis
• Subject has a history of bleeding diathesis or coagulatory disease, refuses blood transfusion, significant gastrointestinal or urinary bleed within the past 12 months
• Subject who underwent or needs organ transplant
• Planned PCI for any clinically significant lesion after index procedure
• Planned surgery within 12 months after index procedure

Sponsors & Collaborators

• Meril Life Sciences Pvt. Ltd.: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: June 14, 2022
• Study Start: October 15, 2022
• Primary Completion: September 23, 2023
• Study Completion: September 23, 2023
• Last Updated: April 17, 2026

Record last verified: 2025-09