Coronary Artery DiseaseBIOMAG-LLNCT07091682
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
A study testing Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold in people with Coronary Artery Disease and Atherosclerosis of Coronary Artery, run by Biotronik AG at 14 sites in 7 countries.
Trial summary
The study objective is the assessment of safety and clinical performance of Freesolve 35- and 40-mm in de novo coronary artery lesions up to 38 mm length. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis of Coronary Artery, Myocardial Ischemia
- What is being tested?
- Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 14 sitesin 7 countries
- Study dates
- 18 Feb 2025to Jun 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Inclusion Criteria
- 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
Show all 19Show fewer
- 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)
- Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor, cangrelor or ticlopidine
- Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to enrollment)
- Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study
- Angiographic Inclusion Criteria
- 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 2.7-4.2 mm by visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) / Intravascular Ultrasound (IVUS) / Optical Coherence Tomography (OCT)
- Target lesion must be >28 mm and ≤ 38 mm in length by operator visual estimation, which may be assisted by QCA / IVUS / OCT, 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
Who cannot join
- Clinical Exclusion Criteria
- 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 (time window is defined as the time from the end of previous intervention to the start of index procedure)
- 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)
Show all 28Show fewer
- 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 (or similar limus drugs), poly L-lactide, the scaffold material (magnesium, aluminum, tantalum)
- 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)
- Life expectancy less than 1 year
- Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained.
- In the investigator's opinion subject will not be able to comply with the follow-up requirements
- 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
- Subject has had a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure .
- Subject with active bleeding disorder, active coagulopathy, or any other reason, who is ineligible for DAPT.
- Subject is currently participating or plans to participate in another study with an investigational device or an investigational drug
- Angiographic Exclusion Criteria:
- Target vessel has been previously treated and the target lesion is within 5 mm proximal or distal to the previously treated lesion.
- Left main coronary artery disease
- Target lesion was totally occluded (100% stenosis)
- Thrombus in target vessel
- Future planned staged PCI either in target or non-target vessel
- Ostial target lesion within the left descending (LAD), left circumflex (LCx), or right coronary artery (within 5.0 mm of vessel origin)
- Target lesion involves a side branch ≥ 2.0 mm in diameter that requires a two-device strategy after pre-dilatation.
- Target lesion is located in or supplied by an arterial or venous bypass graft.
- 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.
- The target lesion requires treatment with the device other than the non-compliant balloon and/or cutting/scoring balloon prior to scaffold placement (including but not limited to atherectomy devices, intravascular lithotripsy, drug-coated balloons etc.)
- Target vessel was treated with brachytherapy any time prior to the index procedure.
- 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)
Trial locations and contacts
14 sites in 7 countries.
14 sites in 7 countries
Germany4 sites
Katholisches Krankenhaus "St. Johann Nepomuk"
Erfurt, 99097
Universitätsklinikum Halle (Saale)
Halle, 6120
Klinikverbund Allgäu gGmbH
Immenstadt and Kempten, 87509
Klinikum der Ludwig-Maximilians-Universität München
München, 81377
Spain3 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital de la Princesa
Madrid, 28006
Hospital Clinic Universitario de Valladolid
Valladolid, 47003
Italy2 sites
Centro Cardiologico Monzino SpA
Milan, 20138
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
Switzerland2 sites
University Hospital Basel
Basel, 4031
HUG Hospitaux Universitaires de Geneve
Geneva, 1205
About this study
Official title: BIOTRONIK - Safety and Clinical Performance of the Drug Eluting Resorbable MAGnesium Scaffold (Freesolve) in the Treatment of Subjects With Long de Novo Lesions in Native Coronary Arteries: BIOMAG-LL
The study objective is the assessment of safety and clinical performance of Freesolve 35- and 40-mm in de novo coronary artery lesions up to 38 mm length.
Read the detailed description
In the study presented here, an extension of the Freesolve size range (35 and 40 mm scaffold length) will be investigated with the aim of assessment the safety and clinical performance of 35 and 40 mm Freesolve in de novo coronary artery lesions up to 38 mm in length to support CE certification of these sizes.
BIOMAG-LL is a pre-marketing study. It is a prospective, international, multi-center, single arm trial. The primary endpoint of the study will be Target Lesion Failure (TLF) rate at 12 months. Clinical follow-up will be conducted at 1, 6, 12, 36, and 60 months post-procedure.
The total duration of the study is approximately six and a half years, including the fifteen-month recruitment phase and the five-year follow-up period. A sample size of 100 patients is expected.
In addition, it is intended to conduct a pharmacokinetic substudy. The objective of this substudy is to describe the pharmacokinetics of sirolimus delivered by Freesolve. For this purpose, 15 patients will be prospectively enrolled in the substudy with a whole blood sample collected up to seven days after the procedure.
- Conditions
- Coronary Artery Disease, Atherosclerosis of Coronary Artery, Myocardial Ischemia, Ischemic Heart Disease, Acute Coronary Syndromes, Angina Pectoris
- Being tested
- Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
- Keywords
- Resorbable Magnesium Scaffold, Sirolimus, RMS, Drug eluting absorbable metal scaffold
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium ScaffoldDevice
Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All subjects will be implanted with the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (Freesolve 35- and 40-mm scaffold) and followed up until 60 months. Receives: Device: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start18 Feb 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Flavio Luciano Ribichini, Prof. Dr., Principal investigator, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091682
- Sponsor's protocol ID
- C2301
- Acronym
- BIOMAG-LL
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No