Resorbable Magnesium Scaffolds Registry
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBiotronik AG
About this trial
The registry follows the ESC/EACTS guideline and further investigates the clinical performance and short-term safety of RMS (Resorbable Magnesium Scaffolds) in a real world setting within the scope of its intended use without further (medical related) exclusion criteria according to their respective instructions for use (IFU).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
According to the IFU
Disqualifiers
According to the IFU
Trial population
Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Magmaris
DeviceMAGMARIS is indicated for improving luminal diameter in the treatment of de novo native coronary artery lesions in patients with symptomatic coronary artery disease. The reference vessel diameter should closely match the scaffold nominal diameter. The treated lesion length should be less than the nominal scaffold length.
Freesolve
DeviceFreesolve is indicated for improving luminal diameter in the treatment of de novo native coronary artery lesions in patients with symptomatic coronary artery disease. The reference vessel diameter should closely match the scaffold nominal diameter. The treated lesion length should be less than the nominal scaffold length.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Target Lesion Failure (TLF)
The primary endpoint will be Target Lesion Failure (TLF) at 12 months. TLF is a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven Target Lesion Revascularization (TLR).
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov