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ID04679740

Registry Study on Resorbable Magnesium Scaffolds for Treating Coronary Artery Disease

Led by Biotronik AG · Updated on 2025-11-21

1106

Participants Needed

13

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are monitoring the clinical performance and short-term safety of Resorbable Magnesium Scaffolds RMS used in patients with symptomatic coronary artery disease. This registry follows the ESCEACTS guideline and observes RMS use in real-world settings without additional medical exclusion criteria beyond the devices intended instructions for use. The devices studied include Magmaris and Freesolve, both designed to improve the luminal diameter in the treatment of new native coronary artery lesions. The scaffold size is matched to the vessel diameter, and lesion length is limited to the scaffold length. The study collects data on these devices as they are used according to their approved instructions. Participants will be followed to assess the primary outcome of Target Lesion Failure within 12 months after device implantation. The registry collects clinical information during routine care to evaluate device performance and safety over time. The study started in November 2020 and will continue through May 2030.

CONDITIONS

Brief Title

Resorbable Magnesium Scaffolds Registry

Research Team

M

Marina Gattiglio, Dr.

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