Safety and performance of the Freesolve resorbable magnesium coronary scaffold

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

This trial will test whether the Freesolve resorbable magnesium scaffold works as well as a standard Xience drug‑eluting stent for adults with up to two new coronary artery blockages.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1859 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Biotronik AG (Industry-sponsored)
• Locations: 1 site (Neuss)
• Trial ID: NCT05540223 on ClinicalTrials.gov

What this trial studies

BIOMAG‑II is an international, multicenter, randomized, non‑inferiority trial that will enroll about 1,859 patients and randomize them 2:1 to the Freesolve resorbable magnesium scaffold or the Xience everolimus drug‑eluting stent. The primary outcome is Target Lesion Failure at 12 months, with clinical follow‑up visits planned at 1, 6, 12 months and annually up to 5 years. The trial includes patients with up to two de novo lesions in native coronary arteries who are eligible for PCI, including selected stable, unstable angina and stable NSTEMI cases. Sites are located across Europe and the Asia‑Pacific region and procedures are performed in PCI‑capable centers by experienced operators.

Who should consider this trial

Good fit: Adults aged 18–80 who are eligible for PCI with up to two de novo native coronary lesions and who have stable or unstable angina, documented ischemia, or hemodynamically stable NSTEMI (and selected non‑culprit STEMI lesions meeting timing and lesion criteria) are ideal candidates.

Not a fit: Patients with angiographic evidence of thrombus at the target lesion, those ineligible for PCI, those requiring immediate CABG, or patients outside the 18–80 age range are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the Freesolve scaffold could provide vessel support that later dissolves, potentially lowering long‑term complications associated with permanent metal stents.

How similar studies have performed: Previous magnesium‑based resorbable scaffolds have shown encouraging early safety and resorption profiles, although earlier polymeric resorbable scaffolds experienced higher late complication rates.

Eligibility criteria

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)

Where this trial is running

Neuss

• Rheinland Klinikum Neuss GmbH Lukaskrankenhaus Neuss — Neuss, Germany (Recruiting)

Study contacts

• Principal investigator: Michael Haude, MD — Rheinland Klinikum Neuss GmbH Lukaskrankenhaus Neuss
• Study coordinator: Barbara Widmann, PhD

Conditions Coronary Artery Disease; Atherosclerosis, Coronary; Myocardial Ischemia; Ischemic Heart Disease; Acute Coronary Syndrome; Angina Pectoris; Resorbable Magnesium Scaffold; Sirolimus