Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Meril Life Sciences Pvt. Ltd.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 ve...
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 ve...
Eligibility Criteria
Inclusion
- General
- 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
- Angiographic
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2028
Estimated Enrollment :
1872 Patients enrolled
Trial Details
Trial ID
NCT05417893
Start Date
October 15 2022
End Date
June 15 2028
Last Update
June 14 2022
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