NCT05540223

Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System

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: BIOMAG-II: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,859 (estimated)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The Biotronik BIOMAG-II clinical trial is a prospective, international, multi-center, randomized controlled, non-inferiority trial to compare the BIOTRONIK Sirolimus Eluting Resorbable Magnesium Scaffold System (Freesolve RMS) with the Xience Everolimus Eluting Stent System (Xience DES) with respect to Target Lesion Failure (TLF) rate at 12 months. A total of 1859 subjects will be enrolled at approximately 100 study sites Europe and APAC. Subjects will be randomized in a 2:1 ratio to Freesolve or Xience. Clinical follow-up visits will take place at 1, 6, 12 and at 2-, 3-, 4- and 5-years post procedure.

Conditions

• Coronary Artery Disease
• Atherosclerosis, Coronary
• Myocardial Ischemia
• Ischemic Heart Disease
• Acute Coronary Syndrome
• Angina Pectoris

Interventions

Type	Name	Description
DEVICE	Freesolve RMS	Subject undergoes implantation of Freesolve RMS
DEVICE	Xience DES	Subject undergoes implantation of Xience DES

Timeline

• Start date: 2024-05-13
• Primary completion: 2027-02-01
• Completion: 2032-02-01
• First posted: 2022-09-14
• Last updated: 2025-11-21

Locations

1 site across 1 country: Germany