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

NCT07258290 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: G230176
• Study Type: interventional
• Target: 1,859
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Keywords

Resorbable Magnesium Scaffold; Sirolimus; RMS; Drug eluting absorbable metal scaffold

Outcome Measures

Primary Outcomes (1)

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

  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).

  12 months

Secondary Outcomes (14)

• Procedure success

  Hospital Discharge (6-24 hours post-index procedure)

• Device Success

  Hospital Discharge (6-24 hours post-index procedure)

• Target lesion failure (TLF)

  Time Frame: 1, 6 months and 2, 3, 4 and 5 years post-index procedure

• Target Vessel Failure (TVF)

  1, 6, 12 months and 2, 3, 4 and 5 years post-index procedure

• Cardiac death

  1, 6, 12 months and 2, 3, 4 and 5 years post-index procedure

Study Arms (2)

Freesolve RMS

EXPERIMENTAL

Intervention with a Freesolve Sirolimus Eluting Coronary Resorbable Magnesium Scaffold (RMS) System

Device: Freesolve RMS

Xience DES

ACTIVE COMPARATOR

Intervention with a Xience Everolimus Eluting Stent System

Device: Xience DES

Interventions

Freesolve RMS DEVICE

Freesolve Sirolimus-Eluting Coronary Resorbable Magnesium Scaffold (RMS) System, a drug-eluting balloon-expandable resorbable scaffold

Freesolve RMS

Xience DES DEVICE

Xience Everolimus Eluting Stent System

Xience DES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Note: STEMI patients may be eligible for the study for treatment of selected non-culprit lesions, if:

You may not qualify if:

• 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)
• 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
• Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study
• Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with STEMI \< 72 hours prior to the index procedure Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment
• Subject has undergone prior PCI within the target vessel during the last 12 months prior to the index procedure or prior PCI within a non-target vessel \< 72 hours prior to the index procedure
• Subject is on dialysis or has impaired renal function (serum creatinine \> 2.5 mg/dL or 221 µmol/L, determined within 7 days prior to the index procedure)
• Subject has a known allergy to contrast medium that cannot be adequately premedicated, or any known allergy to aspirin, P2Y12 inhibitors, both heparin and bivalirudin, sirolimus, everolimus (or similar limus drugs), poly L-lactide, the scaffold material (magnesium, aluminum, tantalum), or Xience stent material (cobalt, chromium, tungsten, nickel, methacrylic polymer, and fluoropolymer)

Sponsors & Collaborators

• Teleflex: lead

MeSH Terms

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

Condition Hierarchy (Ancestors)

Nervous System Diseases

Central Study Contacts

BIOMAG-III Project Manager

CONTACT

1-866-246-6990; biomag_us@teleflex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2033
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share