MeRethon RCT
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
- Registration Number
- CTRI/2021/08/035665
- Lead Sponsor
- Meril Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
General Inclusion Criteria:
1.Male or female patient �18 years of age
2.Subject who has provided written informed consent
3.Subject must agree to undergo all clinical investigations and follow-up visits as per protocol
4.Subject with documented myocardial ischemia (e.g., stable, unstable angina, or silent ischemia) and who are eligible candidates for elective percutaneous coronary intervention (PCI)
5.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 Inclusion Criteria:
1.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
2.Each target lesion can be fully covered by one scaffold
3.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)
4.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
General Exclusion Criteria:
1.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
2.Any PCI <6 months prior to the index procedure
3.Previous CABG or PCI in the target vessel(s)
4.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 subjectââ?¬•s eligibility
5.Concurrent medical condition with less than three years of life expectancy
6.Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months of baseline visit
7.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
8.Subject with cardiac arrhythmia detected at the time of screening
9.Subject is on immunosuppressant therapy and has immunosuppressive or autoimmune disease
10.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
11.Subject with prior brachytherapy of the target lesion or use of
brachytherapy for the treated site restenosis
12.Subject has a history of bleeding diathesis or coagulatory disease, refuses
blood transfusion, significant gastrointestinal or urinary bleed within the past 12 months
13.Subject who underwent or needs organ transplant
14.Planned PCI for any clinically significant lesion after index procedure
15.Planned surgery within 12 months after index procedure
16.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)
17.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
18.Subject with significant peripheral vascular disease that precludes safe access to sheath or catheter
Angiographic Exclusion Criteria:
1.Target lesion located within 3 mm of the origin of the LAD or LCx
2.Target lesion involving a bifurcation lesion with side branch �2 mm in diameter
3.Highly calcified lesions <
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Target lesion failureTimepoint: Time frame: 1 year
- Secondary Outcome Measures
Name Time Method