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

BIOTRONIK - Safety and Clinical PerFormance of the Drug Eluting Absorbable Metal Scaffold (DREAMS 2nd Generation) in the Treatment of Subjects With de NOvo Lesions in NatiVE Coronary Arteries: BIOSOLVE-II

BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).

Inclusion Criteria:

• Subject is > 18 years and < 80 years of age
• Written subject informed consent available prior to PCI
• Subjects with stable or unstable angina pectoris or documented silent ischemia
• Subject eligible for PCI
• Subject acceptable candidate for coronary artery bypass surgery
• Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions.
• Reference vessel diameter between 2.2-3.8 mm by visual estimation
• Target lesion length ≤ 21 mm by visual estimation
• Target lesion stenosis by visual estimation, assisted by QCA / IVUS: > 50% - < 100%
• Eligible for Dual Anti Platelet Therapy (DAPT)

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