An observational study in Coronary Artery Disease, sponsored by University Hospital, Geneva. Terminated at 6 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by University Hospital, Geneva · Observational
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.
5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 10 is below the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
BIOSOLVE-IV Magmaris Swiss Satellite Registry will include male and female subjects requiring a treatment of de novo coronary artery lesions with Magmaris.
Exclusion Criteria:
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.
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 study is terminated, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Geneva