first in man study of the dreams 2nd generation drug eluting absorbable metal scaffold (biosolve-ii)

Conditions: Coronary Artery Disease; Coronary Artery Stenosis

Summary: 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).


Eligibility criteria:
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

Keywords: dreams drug eluting absorbable metal scaffold scaffold coronary artery disease myocardial ischemia atherosclerosis