First in Man Trial - BIOSOLVE-I

BIOTRONIKS-Safety and Clinical Performance Of the First Drug-Eluting Generation Absorbable Metal Stent In Patients With de Novo Lesions in NatiVE Coronary Arteries (BIOSOLVE - I)

First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety

Inclusion Criteria:

• Patient is > 18 years and < 80 years of age
• Written patient informed consent available prior to PCI
• Patients with stable or unstable angina pectoris or documented silent ischemia
• Patient eligible for PCI
• Patient acceptable candidate for coronary artery bypass surgery

Exclusion Criteria:

• Left ventricular ejection fraction of < 30%
• Presence of a visible thrombus in the target vessel visualized by angiography
• Lesion and/or way to lesion extremely calcified (e.g. IVUS catheter can not reach/cross the lesion)
• Patients with three-vessel where all three vessels require treatment
• Patients with previous CABG in the target vessel(s)
• Patients with known coronary artery spasm
• Myocardial infarction (STEMI/NSTEMI) within 4 weeks of the intended treatment. Determination of CKMB and/or troponin T or I is required.
• Patients with planned major surgery within 12 months after coronary intervention
• Patients with risk of either acetylsalicylic acid, clopidogrel or Prasugrel cessation
• Patients under current Phenprocoumon or Cumarine therapy
• Impaired renal function (serum creatinine > 2.0mg/dl or 177micromol/l, determined within 72 hours prior to intervention)
• Additional coronary lesions (restenotic or de novo) in the same vessel which requires treatment
• Totally occluded coronary artery (TIMI flow 0)
• Lesions located within arterial or venous graft
• Ostial lesions
• Previous and/or planned brachytherapy of target vessel
• Target lesion located in left main coronary artery
• Stroke or TIA < 6 months prior to procedure
• Patient with signs of a cardiogenic shock
• Surgeries of any kind within 30 days prior to screening
• Patient with bleeding diathesis in whom anticoagulation or antiplatelet medication is contraindicated
• Pregnant and/or breast-feeding females or females who intend to become pregnant
• Patient currently enrolled in other investigational device or drug trial
• Patient with expected incompliance to medical (antiplatelet, anticoagulation) therapy