Safety and Clinical Performance of the Freesolve Drug-Eluting Resorbable Magnesium Scaffold for Treating Long New Coronary Artery Lesions

What this Trial Is About

Researchers are evaluating the safety and clinical performance of the Freesolve 35- and 40-mm resorbable magnesium scaffold system for treating patients with long de novo coronary artery lesions up to 38 mm in length. This international, multi-center, single-arm trial focuses on subjects with symptomatic coronary artery disease eligible for percutaneous coronary intervention PCI and aims to support CE certification of these scaffold sizes. The primary outcome is the rate of Target Lesion Failure at 12 months, with follow-up continuing up to five years. Participants will receive implantation of the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System Freesolve with scaffold lengths of 35 or 40 mm. The treatment is a device-based intervention intended for use in native coronary arteries with specific lesion characteristics. All subjects will be followed for up to 60 months post-procedure, with clinical visits scheduled at 1, 6, 12, 36, and 60 months. Additionally, a pharmacokinetic substudy will enroll 15 patients to study sirolimus drug levels using blood samples collected up to seven days after scaffold implantation. During the study, participants will undergo assessments at scheduled follow-up visits to monitor safety and clinical outcomes related to the scaffold implantation. Data will be collected on the occurrence of target lesion failure and other clinical events. Participants are expected to comply with study visits and treatment protocols, including dual antiplatelet therapy. The total study duration is approximately six and a half years, including a 15-month recruitment phase and a five-year follow-up period.

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