RecruitingNCT04679740

Resorbable Magnesium Scaffolds Registry

RMS (Resorbable Magnesium Scaffolds) Registry


Sponsor

Biotronik AG

Enrollment

1,106 participants

Start Date

Nov 18, 2020

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • According to the IFU

Exclusion Criteria1

  • According to the IFU

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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.


Locations(13)

Cairns Hospital

Cairns, Australia

Heart Center Segeberger Kliniken

Bad Segeberg, Germany

Krankenhaus Buchholz

Buchholz, Germany

Klinikum Westfalen, Knappschaft KH

Dortmund, Germany

Klinikum Herford

Herford, Germany

Herz-und Gefäßzentrum Oberallgäu-Kempten

Kempten, Germany

Centro Cardiologico Monzino

Milan, Lombardy, Italy

Daugavpils Regional Hospital

Daugavpils, Latvia

1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie

Lublin, Poland

SUSCCH Banska Bystrica

Banská Bystrica, Slovakia

Lindenhofspital

Bern, Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Solothurner Spitäler AG

Olten, Switzerland

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NCT04679740


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