Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Su… (NCT07258290) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions
United States1,859 participantsStarted 2026-06-11
Plain-language summary
The objective of this study is to assess the safety and efficacy of the Freesolve resorbable magnesium scaffold (RMS) in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to the Xience coronary drug-eluting stent (DES) system
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is ≥ 18 years and ≤ 80 years of age
. Subject has provided written informed consent as approved by the Ethics Committee / Institutional Review Board (IRB) of the respective clinical site prior to the study related procedures
. Subject is eligible for PCI according to the applicable guidelines
. Subject is an acceptable candidate for coronary artery bypass surgery
. Subjects with stable or unstable angina pectoris, documented silent ischemia/abnormal physiologic testing or hemodynamically stable non-ST elevation myocardial infarction (NSTEMI) patients without angiographic evidence of thrombus at target lesion
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses a magnesium scaffold that is designed to dissolve over time rather than leaving a permanent metal stent — can you explain how that difference might affect my heart and my recovery compared to the standard metal stents you'd normally use for my condition?
2The main thing this trial is measuring is whether the treated artery has a 'target lesion failure' within 12 months — what does that actually mean in practice, and how does that rate in this device compare to what you'd expect with a conventional stent for someone with my type of lesion?
3Since this trial is listed as 'Phase NA,' meaning it's not a traditional drug-phase study, what do we already know about the safety record of this specific resorbable magnesium scaffold, and are there any risks that are still considered uncertain?
4How would my care and monitoring over that 12-month follow-up period differ if I joined this trial compared to the standard treatment path you'd recommend for my coronary artery disease?
5If at some point the magnesium scaffold doesn't perform as hoped, what options would still be available to me — would having this device already in place limit or complicate any future interventions?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Target Lesion Failure (TLF) rate at 12 months post-index procedure
. Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine
. Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization)
. Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study
. Subjects with a maximum of two single de novo target lesions each in separate native coronary arteries
. Target vessel must have a reference diameter between 2.5-4.2 mm by operator visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) / Intravascular Ultrasound (IVUS) / Optical Coherence Tomography (OCT)
. Target lesion(s) must be ≤ 36 mm in length by operator visual estimation, which may be assisted by QCA / IVUS / OCT, (or \< 20 mm for target lesion(s) to be treated with a study device \< 3.0 mm in diameter) and must be amenable to treatment with a single study device
. Target lesion stenosis ≥ 50% and \< 100% by operator visual estimation, which may be assisted by QCA / IVUS / OCT. Target lesion stenosis \< 70% by visual estimation, should have clinical justification for treatment as per local standards.
. Target lesion must have a Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 1