Safety and clinical performance of the magnesium bioresorbable coronary stent (Freesolve) in the treatment of subjects with long de novo lesions in native coronary arteries: BIOMAG-LL
Descrizione riassuntiva dello studio
This clinical trial will be conducted at 20 sites in Germany, Switzerland, Spain, Poland, Latvia, and Italy. It is planned to include 100 patients. After patients have given their consent to participate in the study, a vascular assistance device will be used. Follow-up clinical examinations will be performed at 1, 6, and 12 months, and then at 36 and 60 months after the intervention. In a smaller group of study participants, after giving their consent, the concentration of the drug released by the bioresorbable stent Freesolve will be measured. Blood samples will be used to measure the amount of drug released by the bioresorbable stent present in the blood at different times after the implantation of Freesolve in the artery. This is called pharmacokinetic evaluation. As part of the pharmacokinetic evaluation, additional blood samples will be taken before implantation and at 10 minutes, 30 minutes, and 1, 2, 3, 4, 6, 12, 24, 48, and 72 hours, as well as 7 days after the implantation of Freesolve.
(BASEC)
Intervento studiato
In BIOMAG-LL, an extension of the size range of Freesolve (scaffold lengths of 35 and 40 mm) will be studied. The aim of the study is to evaluate the safety and clinical performance of Freesolve 35 and 40 mm in de novo coronary lesions up to 38 mm in length. Patients with clinical symptoms are referred to the investigation center for diagnostic testing. Patients who have agreed to participate and received Freesolve (35 mm and 40 mm) will be followed up at 30 days, 1, 6, 12 months, and after 36 and 60 months post-procedure. A pharmacokinetic evaluation will also be conducted in a small group of patients who have given additional consent.
(BASEC)
Malattie studiate
Coronary arteries (blood vessels in the heart) may have a narrowing that can require treatment. This narrowing can be caused by deposits on the walls of the arteries (atherosclerosis). As a result, the heart does not receive enough oxygen and nutrients, which impairs heart function. This condition is called coronary artery stenosis and can be the cause of clinical symptoms.
(BASEC)
1. Subjects with a maximum of two unique lesions in two distinct coronary arteries, which must be de novo lesions and can each be covered by a single device. 2. Reference vessel diameter between 2.7 and 4.2 mm based on visual estimation, depending on the size of the scaffold used. 3. Target lesion length > 28 and ≤ 38 mm based on visual estimation, depending on the size of the scaffold used. (BASEC)
Criteri di esclusione
1. The subject is pregnant and/or breastfeeding or intends to become pregnant during the study duration. 2. The subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with ST-segment elevation myocardial infarction (STEMI) less than 72 hours prior to the reference procedure. 3. Known allergies: to aspirin, P2Y12 inhibitors, heparin and bivalirudin, sirolimus (or similar drugs), poly L-lactide, or scaffold material (magnesium, aluminum, tantalum). (BASEC)
Luogo dello studio
Ginevra
(BASEC)
Sponsor
BIOTRONIK AG Ackerstrasee 6, 8180 Bülach, Switzerland
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Juan Fernando Iglesias
+41 (0)79 347 48 49
juanfernando.iglesias@clutterhug.chHopitaux Universitaires de Genève
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ginevra
(BASEC)
Data di approvazione del comitato etico
05.03.2026
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
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 (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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