The BIFSORB Pilot Study II (BIFSORB P-II)

A Sirolimus Eluting Bioresorbable Magnesium Stent for Treatment of Coronary Bifurcation Lesions - The BIFSORB Pilot Study II

The purpose of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions.

Bioresorbable stents are promising in treatment of coronary artery disease. The concept of bifurcation treatment using BRS is particular appealing as struts covering the side branch ostium may resorb over time. The aim of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions. Hypothesis: treatment of coronary bifurcation lesions using the Magmaris BRS is safe and feasible. Methods: The study is a proof-of-concept, prospective, single arm study with inclusion of 20 patients. Planned 1-and 12-month follow-up by optical coherence tomography (OCT) and follow-up for clinical endpoints until 5 years. Written informed consent is required before the procedure is performed. Eligible patients with a bifurcation lesion are treated by the provisional technique with mandatory jailing of the side branch and provisional opening of side branch ostium by the mini-kiss technique in case of severe pinching or TIMI-flow less than III. Proximal post-dilatation is mandatory. No dilatation beyond the expansion limits of the stent. At baseline, the target lesion is assessed by OCT before, during and after implantation of the Magmaris BRS. OCT assessment is performed again at 1- and 12-month follow-up, or before if the patient is readmitted with a possible target lesion failure. The operator is not blinded to the OCT images as pre-PCI images should be used for sizing and positioning of the stent, and procedural OCT images are used to optimize stent implantation before performing final OCT.

Percutaneous intervention (PCI), Optical coherence tomography (OCT), Bifurcation lesion, Bioresorbable stents (BRS)

Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

Index based on: side branch ostial area late loss, strut fracture, uncovered non-side branch apposed stent struts, uncovered stent struts in front of side branch, uncovered stent struts on acquired or persistent malapposed struts, persistent malapposition, max neointimal thickness/area stenosis, cumulated extra stent lumen gain

Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts

Measured in segments with: 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation

Measured in segments with: 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation

Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

Inclusion Criteria: Stable angina pectoris Stabilized non-ST elevation myocardial infarction Silent angina pectoris Age > 18 years De novo coronary bifurcation lesion at LAD/diagonal, CX/obtuse marginal or RCA-PDA/posterolateral branch All Medina classes except Medina x.x.1. Diameter of side branch ≥ 2.5 mm Side branch diameter stenosis less than 50% Signed informed consent Exclusion Criteria: ST-elevation infarction within 48 hours Expected survival < 1 year Severe heart failure (NYHA≥III) S-creatinine > 120 µmol/L or GFR < 0.45 mL/min per 1.73 m2 Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine or sirolimus Unable to cover main vessel lesion with one stent Severe tortuosity Severe calcification