First in Men Study: BIOMAG-I

Korábbi kezelés

• Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure.
• Target lesion requiring treatment with a device other than the non-compliant pre-dilatation balloon or scoring balloon prior to scaffold placement (including but not limited to rotational atherectomy, etc.)
• Subject is receiving an oral or intravenous immuno-suppressive therapy (e.g., inhaled steroids are not excluded) or has a known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus) diabetes mellitus is not excluded)
• Planned surgery or dental surgical procedure within 6 months after index procedure unless DAPT will be maintained
• Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet

Más betegség

• Left main coronary artery disease
• Three-vessels with coronary artery disease requiring treatment at time of procedure
• Known allergies to: Acetylsalicylic Acid (ASA), P2Y12 inhibitors, Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material

Laborértékek

• Documented left ventricular ejection fraction (LVEF) ≤ 30% within the last 6 months

Egyéb

• Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
• Planned interventional treatment of any non-target vessel within 12-month post-procedure
• Subjects on dialysis
• Planned intervention of the target vessel post index procedure
• Ostial target lesion (within 5.0 mm of vessel origin)
• Target lesion involves a side branch >2.0 mm in diameter
• Heavily calcified lesion
• Target lesion is located in or supplied by an arterial or venous bypass graft
• Unsuccessful pre-dilatation, defined as a residual stenosis rate more than 20%, estimated by any method and/or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections)
• A stenosis located proximal or distal to the target lesion that might require future revascularization or an impede run off detected during diagnostic angiography
• Life expectancy less than 1 year
• In the investigators opinion, subject will not be able to comply with the follow-up requirements

• Subject is > 18 years and < 80 years of age
• Written subject informed consent available prior to PCI
• Subject eligible for PCI
• Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions and can be covered with 1 device each
• Reference vessel diameter between 2.5-4.2 mm by visual estimation, depending on the scaffold size used
• Target lesion length ≤ 28 mm by visual estimation, depending on the scaffold size used
• Target lesion stenosis by visual estimation > 50% - < 100% and TIMI flow ≥1 (assisted by e.g. QCA / IVUS /FFR).
• Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients without angiographic evidence of thrombus at target lesion
• Eligible for Dual Anti Platelet Therapy (DAPT)