Vascular Implant Safety and Efficacy Study

Inclusion criteria

• Subject is > 18 years and < 85 years old
• Written subject informed consent
• Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients
• Subject is eligible for percutaneous coronary intervention (PCI)
• Subject is acceptable candidate for coronary artery bypass surgery
• Subject is eligible for Dual Anti Platelet Therapy (DAPT)
• Subjects with a maximum of two single discrete de novo lesions in two separate native coronary arteries that can be treated with the study stent during the index procedure
• Reference vessel diameter of 3.0 mm to 3.8 mm by visual estimation.
• Target lesion length up to 22 mm by visual estimation.
• Target lesion with ≥ 50% and < 100% stenosis by visual estimation

Exclusion criteria

• Left main coronary artery disease
• Three-vessel coronary artery disease at the time of index procedure
• Angiographic evidence of thrombus in target vessel
• Chronic total occlusion
• Heavily calcified or extremely tortuous lesions that would prevent complete inflation of a pre-dilatation balloon
• Bifurcation lesion requiring side branch intervention, if side branches > 2mm in diameter are involved
• Ostial lesions (within 5 mm of vessel origin)
• In-stent restenosis
• Lesions with prior treatment with a drug coated balloon (DCB)
• Target lesion is located in or supplied by an arterial or venous bypass graft
• Target lesion requires treatment with. rotational atherectomy
• Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
• Previous treatment of target vessel within 9 months of index-procedure
• Patients with cardiogenic shock
• Documented left ventricular ejection fraction (LVEF) ≤ 30%
• Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
• Hemodynamically unstable NSTEMI or STEMI within 72 hours prior to index procedure
• Cerebrovascular event (within 3 months of index procedure)
• Subject is receiving oral or intravenous immuno-suppressive therapy (inhaled steroids are allowed) or has known life-limiting immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus, but not diabetes mellitus)
• Known allergies to: Acetylsalicylic Acid (ASA), heparin, contrast medium, sirolimus, or similar drugs, exipients or the stent material
• Triple anticoagulation therapy
• Life expectancy less than 1 year
• Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
• Inability to understand or read the informed consent form
• Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
• In the investigators opinion subjects will not be able to comply with the follow-up requirements