Resorbable Magnesium Scaffolds Registry

NCT04679740 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1106

Last updated 2025-11-21

No results posted yet for this study

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).

Conditions

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.

Sponsors & Collaborators

  • Biotronik AG

    lead INDUSTRY

Principal Investigators

  • Stefano Galli, MD · Centro Cardiologico Monzino

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-18
Primary Completion
2030-05-31
Completion
2030-05-31

Countries

  • Australia
  • Germany
  • Italy
  • Latvia
  • Poland
  • Slovakia
  • Switzerland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04679740 on ClinicalTrials.gov