Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System

NCT05540223 | Recruiting DMC

• 2 other identifiers: C1801BIOMAG-II - EU, Asia and AUS
• Study Type: interventional
• Target: 1,859
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the safety and efficacy of the Freesolve in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to a contemporary drug eluting stent (DES).

Conditions

Coronary Artery Disease; Atherosclerosis, Coronary; Myocardial Ischemia; Ischemic Heart Disease; Acute Coronary Syndrome; Angina Pectoris

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure

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

  12 Months

Study Arms (2)

Freesolve RMS

EXPERIMENTAL

Intervention with a Freesolve Sirolimus Eluting Resorbable Coronary Magnesium Scaffold System

Device: Freesolve RMS

Xience DES

ACTIVE COMPARATOR

Intervention with a Xience Everolimus Eluting Stent System

Device: Xience DES

Interventions

Freesolve RMS DEVICE

Subject undergoes implantation of Freesolve RMS

Also known as: DREAMS 3G Sirolimus Eluting Resorbable Coronary Magnesium Scaffold System

Freesolve RMS

Xience DES DEVICE

Subject undergoes implantation of Xience DES

Also known as: 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 Independent Ethical Committee (IEC) or 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 visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) / Intravascular Ultrasound (IVUS) / Optical Coherence Tomography (OCT)
• Target lesion must be ≤28mm in length by operator visual estimation, which may be assissted by QCA / IVUS / OCT, (or \< 20 mm for target lesion(s) to be treated with a study device \< 3.0 mm in diameter) and should 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 if successful and uncomplicated
• Subject is on dialysis or with impaired renal function (serum creatinine \> 2.5 mg/dL or 221 µmol/L, determined within 72 hours prior to the index procedure)

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (1)

Rheinland Klinikum Neuss GmbH Lukaskrankenhaus Neuss

Neuss, 41464, Germany

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Acute Coronary Syndrome; Angina Pectoris

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Haude, MD

  Rheinland Klinikum Neuss GmbH Lukaskrankenhaus Neuss

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Widmann, PhD

CONTACT

0041 75 429 5530; barbara.widmann@teleflex.com

Nadine Kluser

CONTACT

0041 75 429 54 82; nadine.kluser@teleflex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 14, 2022
• Study Start: May 13, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2032
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)