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NCT04679740 Clinical Trial

Resorbable Magnesium Scaffolds Registry

Coronary Artery Disease Clinical Trial

Official title:
RMS (Resorbable Magnesium Scaffolds) Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04679740
Other study ID # C1908
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 18, 2020
Est. completion date December 1, 2026

Study information
Verified date May 2023
Source Biotronik AG
Contact Dimitra Antonopoulou, M.Sc.
Phone 0041448645753
Email dimitra.antonopoulou@biotronik.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 1106
Est. completion date December 1, 2026
Est. primary completion date December 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - According to the IFU Exclusion Criteria: - According to the IFU

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Germany Heart Center Segeberger Kliniken Bad Segeberg
Germany Herz-und Gefäßzentrum Oberallgäu-Kempten Kempten

Sponsors (1)
Lead Sponsor Collaborator
Biotronik AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Target Lesion Failure (TLF) 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). 12 months
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