Coronary Artery Disease
Conditions
Keywords
Registry, Magmaris, Coronary Artery Disease, PCI, Resorbable Magnesium Scaffolds, Freesolve
Brief summary
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).
Interventions
DEVICEMagmaris
MAGMARIS 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.
DEVICEFreesolve
Freesolve 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.
Sponsors
Biotronik AG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* According to the IFU
Exclusion criteria
* According to the IFU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | 12 months | 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). |
Countries
Australia, Germany, Italy, Latvia, Poland, Slovakia, Switzerland
Contacts
Primary ContactMarina Gattiglio, Dr.
Outcome results
None listed