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NCT07258290

Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions

Recruiting
NAAges 18–80InterventionalTreatment
Teleflex
~1,859 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Freesolve RMSXience DES

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Target Lesion Failure (TLF) rate at 12 months post-index procedure
Measured over 12 months

Conditions

Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Pathological Conditions, Signs and Symptoms
Coronary Artery Disease
Myocardial Ischemia
Acute Coronary Syndrome
Angina Pectoris

Explore related trials

Acute Coronary SyndromeAnginaCoronary Artery DiseaseIschemic Heart Disease

Where it's being run

2 sites across 2 states
District of Columbia1
West Virginia1

Who to contact

BIOMAG-III Project Manager
[email protected]
1-866-246-6990
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Eligibility criteria

Inclusion

Subject is hemodynamically stable with documented declining cardiac biomarkers;
Target lesion(s) to be treated are not located in the culprit vessel(s) and are not culprit lesion(s) 6. Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine 7. Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization) 8. Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study

What this trial measures

  • Target Lesion Failure (TLF) rate at 12 months post-index procedure12 months

    The primary endpoint is Target Lesion Failure (TLF) at 12 months, a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven target lesion revascularization (TLR).