Clinical Trial

Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System

Study acronym: BIOMAG-II
Active, Not Recruiting
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Summary
The objective of this study is to assess the safety and efficacy of the Freesolve in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to a contemporary drug eluting stent (DES).
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-09-12; most recent amendment 2026-07-06.
Status change: Recruiting → Active, Not Recruiting 2026-07-06
Status change: Not Yet Recruiting → Recruiting 2025-11-18
Trial Details
NCT Number NCT05540223
Lead Sponsor Biotronik AG
Conditions Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease, Acute Coronary Syndrome, Angina Pectoris
Enrollment 1,861 participants
Start Date 2024-05-13
Primary Completion 2027-02 (estimated)
Study Completion 2032-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-07