Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System (BIOMAG-II)

BIOTRONIK - Safety and Clinical Performance of the Drug Eluting Resorbable Coronary Magnesium Scaffold System (Freesolve®) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries: BIOMAG-II: A Randomized Controlled Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Angina Pectoris; Acute Coronary Syndrome; Ischemic Heart Disease; Atherosclerosis, Coronary
• Intervention / Treatment: Device: Xience DES; Device: Freesolve RMS

Detailed Description

The Biotronik BIOMAG-II clinical trial is a prospective, international, multi-center, randomized controlled, non-inferiority trial to compare the BIOTRONIK Sirolimus Eluting Resorbable Magnesium Scaffold System (Freesolve RMS) with the Xience Everolimus Eluting Stent System (Xience DES) with respect to Target Lesion Failure (TLF) rate at 12 months. A total of 1859 subjects will be enrolled at approximately 100 study sites Europe and APAC. Subjects will be randomized in a 2:1 ratio to Freesolve or Xience.

Clinical follow-up visits will take place at 1, 6, 12 and at 2-, 3-, 4- and 5-years post procedure.

• Study Type: Interventional
• Enrollment (Estimated): 1859
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbara Widmann, PhD; Phone Number: 0041 75 429 5530; Email: barbara.widmann@teleflex.com
• Study Contact Backup: Name: Nadine Kluser; Phone Number: 0041 75 429 54 82; Email: nadine.kluser@teleflex.com

Study Locations

• Germany
  • Neuss, Germany, 41464
    • Recruiting
    • Rheinland Klinikum Neuss GmbH Lukaskrankenhaus Neuss
    • Contact: Michael Haude, Prof. Dr.; Phone Number: +49 2131 888 2000; Email: michael.haude@rheinlandklinikum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Clinical Inclusion Criteria:

1. Subject is ≥ 18 years and ≤ 80 years of age
2. 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
3. Subject is eligible for PCI according to the applicable guidelines
4. Subject is an acceptable candidate for coronary artery bypass surgery

5. 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:

   • Subject and target lesion(s) meet all inclusion and no exclusion criteria and consent occurs at least ≥ 72 hours after successful treatment of the culprit lesion(s) [lesion(s) causing the acute STEMI];
   • 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

Angiographic Inclusion Criteria:

1. Subjects with a maximum of two single de novo target lesions each in separate native coronary arteries
2. 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)
3. 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
4. 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.
5. Target lesion must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥1

Clinical Exclusion Criteria:

1. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study

2. 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.

3. 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
4. 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)
5. 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, aluminium, tantalum), or Xience stent material (cobalt, chromium, tungsten, nickel, -methacrylic polymer, and fluoropolymer)
6. Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted)
7. Life expectancy less than 1 year
8. Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained
9. In the investigator's opinion subject will not be able to comply with the follow-up requirements
10. Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e. triple therapy) can be maintained for a minimum of 1 month
11. Subject has had a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure
12. Subject with active bleeding disorder, active coagulopathy, or any other reason, who is ineligible for DAPT
13. Subject is currently participating or plans to participate in another study with an investigational device or an investigational drug

Angiographic Exclusion Criteria:

1. Target vessel has been previously treated and the target lesion is within 5 mm proximal or distal to the previously treated lesion
2. Left main coronary artery disease
3. Target lesion was totally occluded (100% stenosis)
4. Thrombus in target vessel
5. Future planned staged PCI either in target or non-target vessel
6. Ostial target lesion within the left descending (LAD), left circumflex (LCx), or right coronary artery (within 5.0 mm of vessel origin)
7. Target lesion involves a side branch ≥ 2.0 mm in diameter that requires a two-device strategy after pre-dilatation
8. Target lesion is located in or supplied by an arterial or venous bypass graft
9. Target lesion with excessive tortuosity proximal to or within the lesion based on visual estimation or heavily calcified target lesion which cannot be adequately pre-dilated by a non-compliant and/or cutting/scoring balloon as described in angiographic exclusion criteria 10.
10. The target lesion requires treatment with the device other than the non-compliant balloon and/or cutting/scoring balloon prior to scaffold/stent placement (including but not limited to atherectomy devices, intravascular lithotripsy, drug-coated balloons etc.)
11. Target vessel was treated with brachytherapy any time prior to the index procedure.
12. Unsuccessful pre-dilatation, defined as residual stenosis > 20% (by visual estimation) and / or angiographic complications (e.g. distal embolization, side branch closure, flow-limiting dissections)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Xience DES; Intervention with a Xience Everolimus Eluting Stent System	Device: Xience DES; Subject undergoes implantation of Xience DES; Other Names: Xience Everolimus Eluting Stent System
Experimental: Freesolve RMS; Intervention with a Freesolve Sirolimus Eluting Resorbable Coronary Magnesium Scaffold System	Device: Freesolve RMS; Subject undergoes implantation of Freesolve RMS; Other Names: DREAMS 3G Sirolimus Eluting Resorbable Coronary Magnesium Scaffold System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Biotronik AG
• Collaborators: Biotronik AG
• Investigators: Principal Investigator: Michael Haude, MD, Rheinland Klinikum Neuss GmbH Lukaskrankenhaus Neuss

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2032

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Sirolimus; RMS; Resorbable Magnesium Scaffold; Drug eluting absorbable metal scaffold
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Chest Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Coronary Artery Disease; Myocardial Ischemia; Acute Coronary Syndrome; Angina Pectoris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Protein Kinase Inhibitors; Antibiotics, Antineoplastic; Antifungal Agents; MTOR Inhibitors; Everolimus; Sirolimus
• Other Study ID Numbers: C1801; BIOMAG-II - EU, Asia and AUS (Other Identifier: BIOTRONIK AG)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: An IPD plan is being developed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No