Resorbable Magnesium Scaffolds Registry

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).

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairns Hospital, Cairns, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

According to the IFU

Exclusion criteria

According to the IFU

Treatment and study plan

Magmaris

Device

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.

Other names: Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold

Freesolve

Device

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.

Other names: Freesolve Sirolimus-Eluting Coronary Resorbable Magnesium Scaffold (RMS) System

Primary outcomes

Target Lesion Failure (TLF)

Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Marina Gattiglio, Dr.

CONTACT

[email protected]

+41754295843

Sponsors and collaborators

Lead sponsor

Biotronik AG

Industry

Registry information

Official study title

RMS (Resorbable Magnesium Scaffolds) Registry

Important dates

Study start: 2020
Primary completion: 2030
Study completion: 2030
First posted: Dec 22, 2020
Registry last updated: Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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