First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme and Resolute Integrity in Patients With de Novo Coronary Artery Stenosis

Inclusion criteria

• The subject is at least 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 a single de-novo lesion in one or two separate major epicardial territories (LAD, LCX or RCA).
• Diameter Stenosis≥50 and<100%.
• The visually estimated target lesion must be able to be covered by a single BuMA Supreme stent or a single Resolute Integrity stent (for available sizes refer to tables 1 and 2, page 20 and 21).
• The target lesion reference diameter must be visually estimated to be ≥2.5 mm and ≤4.5 mm in diameter.
• Written informed consent.
• The patient agrees to the follow-up visits including a 9 month angiographic follow-up.
• Patient must have completed the follow-up phase of any previous study.

Exclusion criteria

• Female of child bearing potential (age <50 years and last menstruation within the last 12 months). Subjects with age <50 who underwent tubal ligation, ovariectomy or hysterectomy can be included.
• Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure
• Patient suffered from stroke/TIA during the last 6 months.
• LVEF <30%
• Platelet count <100,000 cells/mm3 or >400,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
• Known renal insufficiency (e.g. serum creatinine >2.5mg/dL, or creatinine clearance ≤30 mL/min), or subject on dialysis, or acute kidney failure (as per physician judgment).
• Patient undergoing planned surgery within 6 months with the necessity to stop DAPT.
• Patient requiring oral anticoagulation (Coumadin, Novel Oral Anticoagulant (NOAC))
• History of bleeding diathesis or coagulopathy
• The patient is a recipient of a heart transplant
• Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study, sirolimus, zotarolimus, or cobalt-chromium.
• Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy
• The patient is simultaneously participating in another investigational device or drug study