BIOMAG-II
Research type
Research Study
Full title
BIOTRONIK – Safety and Clinical Performance of the Drug Eluting Resorbable Coronary MAGnesium Scaffold System (Freesolve®) in the Treatment of Subjects with de Novo Lesions in Native Coronary Arteries: A randomized controlled trial (BIOMAG-II)
IRAS ID
344869
Contact name
Andreas Baumbach
Contact email
Sponsor organisation
BIOTRONIK AG
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 10 months, 1 days
Research summary
Standard of care treatment of coronary artery disease (a blocked artery of the heart) with state-of-the-art drug-eluting stents (DES)(fine, tubular wire mesh that is covered with a drug) delivers good clinical outcomes. Nevertheless, the use of DES presents some limitations, mainly due to the permanent presence of foreign material in the vessel wall. In particular, there is a long-term risk of stent failure, thrombosis (depositions), chronic inflammation due to the metal or polymer components. Moreover the metal cage can impair the vessel geometry, access and flow into side branches, inhibit normal vasomotor function (vessel dilation and constuction), limits use of imaging and future treatment options.
Bioresorbable scaffolds (BRS) were developed to overcome these problems, enabling vessel restoration and reducing long term risks. BRS are meant to provide a temporary drug eluting scaffold, which supports the vessel after implantation, limiting acute recoil (repeated narrowing) and negative re-modelling, and enables a natural biologic reconstruction of the arterial wall and restoration of the vascular function once the scaffold is resorbed.
The BIOTRONIK Freesolve Resorbable Magnesium Scaffold (RMS) and the Xience DES are commercially approved. This means that clinical studies have been conducted to analyze their safety and effectiveness and regulatory authorities have approved their use.
This study aims to prove that the treatment with the Freesolve RMS is non-inferior (at least as effective as the treatment with the Xience DES) compared to the Xience DES. Patients will be randomized (randomly assigned) in a 2:1 fashion Freesolve to Xience.
The total study duration is approximately 7 years, including the estimated enrolment period of approximately 21 months and 5 years follow-up. Each subject will participate for up to 5 years in the trial.REC name
London - Dulwich Research Ethics Committee
REC reference
25/LO/0449
Date of REC Opinion
5 Aug 2025
REC opinion
Further Information Favourable Opinion