Resorbable Magnesium Scaffolds Registry

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT04679740
• Lead Sponsor: Biotronik AG

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-18
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-22
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-18
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1106

Inclusion Criteria

• According to the IFU

Exclusion Criteria

• According to the IFU

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	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).

Trial Locations

Locations (2)

Herz-und Gefäßzentrum Oberallgäu-Kempten; 🇩🇪 Kempten, Germany

Heart Center Segeberger Kliniken; 🇩🇪 Bad Segeberg, Germany