BioMime Vs. Xience Randomised Control Clinical Study (meriT-V)

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Arteriosclerosis Read More

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