First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)

Exclusion Criteria

• •Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
• •Evidence of myocardial infarction within 72 hours prior to index procedure
• •Subjects with a ≥2 fold CK level or in absence of CK a ≥3 fold CKMB level above the upper range limit within 24 hours prior to the procedure
• •Unprotected left main coronary artery disease
• •Three-vessel coronary artery disease at time of procedure
• •Thrombus in target vessel
• •Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
• •Planned interventional treatment of any non-target vessel within 30 days post-procedure
• •Subjects on dialysis
• •Planned intervention of the target vessel within 6-month after the index procedure
• •Ostial target lesion (within 5.0 mm of vessel origin)
• •Target lesion involves a side branch \>2.0 mm in diameter
• •Documented left ventricular ejection fraction (LVEF) ≤ 30%
• •Heavily calcified lesion
• •Target lesion is located in or supplied by an arterial or venous bypass graft
• •The target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to, rotational atherectomy, cutting balloon etc.)
• •Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
• •Impaired renal function (serum creatinine \> 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
• •Subject is receiving oral or intravenous immuno-suppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
• •Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
• •Life expectancy less than 1 year
• •Planned surgery or dental surgical procedure within 6 months after index procedure
• •In the investigators opinion subjects will not be able to comply with the follow-up requirements