Coronary Artery DiseaseMeRethonRCTNCT05417893
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
A study testing MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS) in people with Coronary Artery Disease, run by Meril Life Sciences Pvt. Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2022to 23 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 38Show fewer
- 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
- Pregnant or nursing subject and those who plan pregnancy in the period until 5 years following index procedure (Female subject of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and contraception must be used during participation in this trial)
- Any newly onset acute myocardial infarction within 1 week (<7days) or, myocardial enzyme has not returned to normal level (clinically non-significant) after myocardial infarction.
- Subject with significant peripheral vascular disease that precludes safe access to sheath or catheter
- Angiographic Exclusion Criteria:
- Target lesion located within 3 mm of the origin of the LAD or LCx
- Target lesion involving a bifurcation lesion with side branch ≥2 mm in diameter
- Highly calcified lesions Classification of calcification: moderate calcification - discontinuous dotted high density image; severe calcification - continuous high density image around the whole vessel wall under continuous X ray by multiple positions.
- Target lesion which prevents complete balloon pre-dilatation, defined as full balloon expansion with the following outcomes:
- Residual % Diameter Stenosis (DS) is < 40% (per visual estimation), (≤ 20% is strongly recommended).
- TIMI Grade-3 flow (per visual estimation).
- No angiographic complications (e.g., no-reflow, distal embolization, side branch closure).
- No dissections NHLBI grade D-F.
- No chest pain lasting > 5 minutes.
- No ST depression or elevation lasting > 5 minutes
- Total occlusion (TIMI flow 0), prior to wire crossing
- Excessive tortuosity (≥ two 45° angles), or extreme angulation (≥90°) proximal to or within the target lesion
- Lesion is located in left main coronary artery
- Thrombus in the target vessel determined by angiography or OCT
- Subject with three-vessel disease where all three vessels require intervention
- Additional lesion in same coronary vessel which requires treatment
- Evidence of previous revascularization
- Previous PCI with or without restenosis from previous intervention
- Arterial or venous graft with or without lesion located within the graft or distal to a diseased arterial or saphenous vein graft Note: Lesions within 3 mm of the origin of the right coronary artery may be treated
About this study
Official title: 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
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]
Read the detailed description
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]
- Conditions
- Coronary Artery Disease
- Being tested
- MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS)Device
Also called 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)
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort-1: MeRes 100 BRS | Active comparator | 1248 subjects will be delivered with MeRes 100 BRS Receives: 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 Receives: Device: MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
It is a composite of cardiovascular death, target vessel myocardial infarction (TVMI) and clinically driven target lesion revascularization (CD TLR).
Measured: 1 year
Secondary outcomes (10)
Target Lesion Failure (TLF)
It is a composite of cardiovascular death, target vessel myocardial infarction and clinically driven target lesion revascularization
Measured: 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.
Measured: 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
Measured: 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:
- Core laboratory-reported fractional flow reserve ≤0.80 or instant wave-free ratio ≤0.89
- Site-reported fractional flow reserve ≤0.80 or instant wave-free ratio ≤0.89
- Quantitative coronary analysis diameter stenosis >50% (based on the average of multiple views) with either recurrent symptoms or positive non-invasive functional test
- Quantitative coronary analysis diameter stenosis >70% (based on the average of multiple views) regardless of other criteria
- Quantitative coronary analysis diameter stenosis >70% (based on the worst view) regardless of other criteria
Measured: 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
Measured: 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
Measured: 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
Measured: : 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
Measured: 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
Measured: 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)
Measured: Baseline, 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start15 Oct 2022
- Primary completion23 Sep 2023
- Study completion23 Sep 2023
Why it stopped: Operational and feasibility constraints due to regulatory requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417893
- Sponsor's protocol ID
- MLS/MER/MeRethon RCT
- Acronym
- MeRethonRCT
- Status last verified
- Sep 2025
- First submitted
- 7 Mar 2022
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05417893
- Acronym / sponsor ID
- MeRethonRCT / MLS/MER/MeRethon RCT
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Operational and feasibility constraints due to regulatory requirements
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 23 Sep 2023 (actual)
- Study completion
- 23 Sep 2023 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort-1: MeRes 100 BRS | Active comparator | Device: MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS)1248 subjects will be delivered with MeRes 100 BRS |
| Cohort- 2: Contemporary DES platforms | Active comparator | Device: MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS)624 subjects will be delivered with Contemporary DES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS)Also: 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)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. | Device | Cohort- 2: Contemporary DES platforms, Cohort-1: MeRes 100 BRS |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 1 year
It is a composite of cardiovascular death, target vessel myocardial infarction (TVMI) and clinically driven target lesion revascularization (CD TLR).
10 secondary outcomes
Target Lesion Failure (TLF)
Time frame: 30 days, 6 months, 2 years, 3 years, 4 years and 5 years
Cardiovascular Death
Time frame: 30 days, 6 months, 2 years, 3 years, 4 years and 5 years
Target Vessel Myocardial Infarction
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Clinically Driven Target Lesion Revascularization
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Target Vessel Failure
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Target Vessel Revascularization
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Scaffold/Stent Thrombosis Rate
Time frame: : 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Device Success
Time frame: From the start of Index Procedure till 5 years follow ups subsequently
Procedure Success
Time frame: From the start of Index Procedure till 5 years follow ups subsequently
Quality of Life Short Form Survey (SF-12)
Time frame: Baseline, 30 days and 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS) in people with Coronary Artery Disease, run by Meril Life Sciences Pvt. Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.