BIOSOLVE-IV Magmaris Swiss Satellite Registry is a prospective, single-arm, multicenter, nationwide open label registry. It is planned to enroll 200 subjects in up to 12 participating sites in Switzerland. After percutaneous coronary intervention (PCI) with the Magmaris scaffold and signature of the informed consent form, all subjects will be followed through hospital discharge and will undergo follow up evaluations at 6, 12 and 24 months post procedure. The follow up evaluations, part of the standard care can be either performed on site (12 months) or by phone (6 and 24 months) and according to routine clinical practice.
Study Type
OBSERVATIONAL
Enrollment
10
Subjects will undergo a percutaneous coronary intervention for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice. Maximum of two single de novo lesions in two separate major epicardial vessels are allowed.
Unité de Cardiologie interventionnelle, Service de cardiologie, Hôpitaux Universitaires de Genève
Geneva, Switzerland
Kantonsspital Baselland, Kardiologie
Liestal, Switzerland
Ensemble Hospitalier de la Côte, Hôpital de Morges, Cardiologie
Morges, Switzerland
Interventionnelle Kardiologie, Kantonspital St.Gallen, Kardiologie
Sankt Gallen, Switzerland
Target Lesion Failure at 12 months
Target Lesion Failure (TLF, a composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction, and clinically driven Target Lesion Revascularization) at 12 months
Time frame: 12 months
Target Lesion Failure
Target Lesion Failure (TLF) at 6, 12 and 24 months
Time frame: 6 months and annually thereafter up to 2 years post-procedure
Clinically driven Target Lesion Revascularization
Clinically driven Target Lesion Revascularization (TLR) at 6, 12 and 24 months
Time frame: 6, 12 months and 24 months post-procedure
Clinically driven Target Vessel Revascularization
Clinically driven Target Vessel Revascularization (TVR) at 6, 12 and 24 months
Time frame: 6, 12 months and 24 months post-procedure
Cardiac death
Cardiac death at 6, 12 and 24 months
Time frame: 6, 12 and 24 months post-procedure
Target Vessel Myocardial Infarction
Target Vessel Myocardial Infarction (MI) at 6, 12 and 24 months
Time frame: 6, 12 and 24 months post-procedure
Scaffold thrombosis
Scaffold thrombosis at 6, 12 and 24 months
Time frame: 6, 12 and 24 months post-procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hôpital du Valais Sion
Sion, Switzerland
HFR Fribourg, Cardiologie
Villars-sur-Glâne, Switzerland