NCT07091682

Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions

BIOTRONIK - Safety and Clinical Performance of the Drug Eluting Resorbable MAGnesium Scaffold (Freesolve) in the Treatment of Subjects With Long de Novo Lesions in Native Coronary Arteries: BIOMAG-LL

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study objective is the assessment of safety and clinical performance of Freesolve 35- and 40-mm in de novo coronary artery lesions up to 38 mm length.

Detailed description

In the study presented here, an extension of the Freesolve size range (35 and 40 mm scaffold length) will be investigated with the aim of assessment the safety and clinical performance of 35 and 40 mm Freesolve in de novo coronary artery lesions up to 38 mm in length to support CE certification of these sizes. BIOMAG-LL is a pre-marketing study. It is a prospective, international, multi-center, single arm trial. The primary endpoint of the study will be Target Lesion Failure (TLF) rate at 12 months. Clinical follow-up will be conducted at 1, 6, 12, 36, and 60 months post-procedure. The total duration of the study is approximately six and a half years, including the fifteen-month recruitment phase and the five-year follow-up period. A sample size of 100 patients is expected. In addition, it is intended to conduct a pharmacokinetic substudy. The objective of this substudy is to describe the pharmacokinetics of sirolimus delivered by Freesolve. For this purpose, 15 patients will be prospectively enrolled in the substudy with a whole blood sample collected up to seven days after the procedure.

Conditions

• Coronary Artery Disease
• Atherosclerosis of Coronary Artery
• Myocardial Ischemia
• Ischemic Heart Disease
• Acute Coronary Syndromes
• Angina Pectoris

Interventions

Type	Name	Description
DEVICE	Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold	Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold

Timeline

• Start date: 2025-02-18
• Primary completion: 2027-06-01
• Completion: 2031-06-01
• First posted: 2025-07-29
• Last updated: 2025-11-21

Locations

8 sites across 5 countries: Germany, Italy, Latvia, Poland, Spain