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Recruiting NCT04679740

Resorbable Magnesium Scaffolds Registry

Observational Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magmaris, Freesolve.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, Germany, Italy, Latvia, Poland +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

RMS (Resorbable Magnesium Scaffolds) Registry

Overview

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

  • Device Magmaris
    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.
  • Device Freesolve
    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.

Primary outcome measures

  • Target Lesion Failure (TLF) [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • According to the IFU

Exclusion criteria

  • According to the IFU

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Germany · 5 centers
  • Heart Center Segeberger Kliniken — Bad Segeberg
  • Krankenhaus Buchholz — Buchholz
  • Klinikum Westfalen, Knappschaft KH — Dortmund
  • Klinikum Herford — Herford
  • Herz-und Gefäßzentrum Oberallgäu-Kempten — Kempten
Switzerland · 3 centers
  • Lindenhofspital — Bern
  • Centre Hospitalier Universitaire Vaudois — Lausanne
  • Solothurner Spitäler AG — Olten
Australia · 1 center
  • Cairns Hospital — Cairns
Italy · 1 center
  • Centro Cardiologico Monzino — Milan
Latvia · 1 center
  • Daugavpils Regional Hospital — Daugavpils
Poland · 1 center
  • 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie — Lublin
Slovakia · 1 center
  • SUSCCH Banska Bystrica — Banská Bystrica

Publications

  • Wolbert S, Schmidt T, Wittek F, Mayer B, Raake P, Bongiovanni D, Torzewski J. One-year outcomes of bioresorbable magnesium scaffold implantation in complex coronary lesions. Front Cardiovasc Med. 2026 Jun 12;13:1854686. doi: 10.3389/fcvm.2026.1854686. eCollection 2026. PMID 42368841

Identifiers

NCT: NCT04679740 · C1908

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗