BioMime Vs. Xience Randomised Control Clinical Study

Study Overview
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Brief Summary
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meriT-V is a Prospective,active control open lable clinical trial to compare safety & efficacy of BioMime Sirolimus stent Vs. Xience family of Everolimus stent by random assignment for treatment of coronary artery disease at multiple multinational centres.

Detailed Description
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This study is conducted to evaluate the multicenter investigation comparing the BioMime Sirolimus Drug Eluting stent with XIENCE family of (Abbott Vascular, Santa Clara, California, USA) in the treatment of patients with coronary artery disease. Considering that the randomized studies provide a better comparability and a real efficacy and safety data of the devices. Subjects will be randomized 2:1 with surrogate endpoints and clinical evaluation. Subject included in study are eligible to meet the inclusion and exclusion criteria of the study protocol .The informed consent process will be performed before the subject underwent for the Procedure. Subject will be treated with treatment allocated by the process of Randomization. The study follow up will be Seattle angina score evaluation up to 2 years after the procedure of angioplasty along with the Hospital or telephonic follow up at 1 Month 5month ,1 and 2 years and angiographic follow up at 9 Month.

Official Title
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A Prospective, Active Control Open Label, Multicentre Randomized Clinical Trial for Comparison Between BioMime Sirolimus Eluting Stent of Meril Life Sciences and Xience Everolimus Eluting Stent of Abbott Vascular Inc. to Evaluate Efficacy and Safety in Coronary Artery Disease.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Sirolimus Eluting Coronary Stent
* Device: Everolimus-eluting Coronary stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be ≥18 years of age. Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris (Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia The patient has a planned intervention of up to two de-novo native lesions Target lesion reference diameter ≥ 2.5 mm and ≤ 3.5 mm in diameter (visually estimated) The target lesion length is less than or equal to 46 mm (visually estimated) Patient willing to provide written informed consent. If the patient is a female, she should be without childbearing potential who has undergone surgical sterilization or is post-menopausal. The patient and the patient's physician agree to the follow-up visits including a 9 month angiographic follow-up. Exclusion Criteria: Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure, unless the CK and CK-MB enzymes are less than twice the Upper Normal Limit. The patient has a known hypersensitivity or contraindication to any of the requisite medications including aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus, everolimus. There is an untreated significant lesion of > 40% diameter stenosis remaining proximal or distal to the target site after the planned intervention. Previous placement of any stent at the target lesion and/or within 10 mm of the target lesion. Lesion with a significant side branch (branch diameter >2 mm) that would be covered by stenting Total occlusion or TIMI 0 coronary flow in the target vessel. Left Main coronary artery disease (stenosis >50%) The proximal target vessel or target lesion is severely calcified by visual assessment. Aorto-ostial location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the LAD or LCX. The patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions The patient suffered a stroke, transient ischemic neurological attack (TIA) or significant gastrointestinal (GI) bleed within the past 6 months The patient has renal insufficiency as determined by a creatinine of > 2.0mg/dl or 180 µmol/l. The target lesion, or the target vessel proximal to the target lesion contains thrombus Documented left ventricular ejection fraction of ≤30% The patient is a recipient of a heart transplant The patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion or extreme angulations of the vessel at accesslocation (< 45 degrees) The patient has other medical illness (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than one year) The patient is simultaneously participating in another investigational device or drug study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: BioMime Sirolimus Eluting Stent system compared to the Abbott XIENCE family (V, Xpedition or Prime) of Everolimus Eluting Stent system
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sirolimus Eluting Coronary Stent<br>BioMime Sirolimus Eluting Stent of Meril Life Sciences | Device: Sirolimus Eluting Coronary Stent<br>* BioMimeTM Sirolimus Eluting Stent (CE Marked) has cobalt chromium NexGenTM platform (CE Marked) with Tamarin BlueTM balloon Delivery System (CE marked and with FDA clearance under 510k). Stent is coated with combination of Sirolimus drug and Biodegradable PLLA and PDLG polymers.<br>* Other names: BioMime Sirolimus Eluting Stent;|
| Active Comparator: Everolimus-eluting Coronary stent<br>XIENCE family (V, Xpedition or Prime) of Everolimus-eluting stent system of Abbott Vascular Inc. | Device: Everolimus-eluting Coronary stent<br>* Xience V/Xience Xpedition/Xience Prime stent is MULTI-LINK MINI VISION or MULTI-LINK VISION platform Cobalt chromium stent with Everolimus (active ingredient) embedded in a non-erodible polymer (inactive ingredient).<br>* Other names: XIENCE family of Everolimus-eluting stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess in-stent Late Lumen Loss | The primary outcome of this study is to assess in-stent Late Lumen Loss at 9 months for both treatment strategies. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Binary restenosis by Angiography | Binary Restenosis (DS ≥50%) | 9 months | 
| Minimum Lumen Diameter by Angiography | MLD and %DS post procedure at 9 months as compared with pre procedure baseline and post procedure | 9 months | 
| In-segment Late Lumen Loss at 9 months | In-segment Late Lumen Loss at 9 months in-segment and proximal and distal stent margins. | 9 months | 
| Clinical Evaluation | Major Adverse Cardiac Events (MACE) | 1, 5, 9, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Arteriosclerosis