Safety and clinical performance of the magnesium-based bioresorbable coronary stent (Freesolve) in the treatment of patients with lesions in the coronary arteries: BIOMAG-II
Descrizione riassuntiva dello studio
The objective of the study is to evaluate the safety and efficacy of the bioresorbable Freesolve stent from BIOTRONIK in the treatment of patients with up to two stenoses of the coronary arteries, compared to the Abbott Xience stent, which is made of a permanent material. This is an international, multicenter clinical trial to compare the Freesolve stent with the Xience stent regarding the target lesion failure (TLF) rate at 12 months. TLF is a composite rate of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) rate. Patients will be randomly implanted either with the bioresorbable Freesolve stent (intervention group) or with the permanent Xience stent (control group) and will be followed up to 5 years after the intervention.
(BASEC)
Intervento studiato
The common name for the intervention is percutaneous transluminal coronary angioplasty (PTCA). During this procedure under local anesthesia, a catheter will be placed inside the groin or arm to access an artery. A bioresorbable Freesolve stent or a Xience stent will be implanted in the coronary artery requiring treatment. The correct positioning is monitored by angiography, and a balloon is inflated to open the prosthesis and press it against the vessel wall. Then, the deflated balloon is removed from the vessel, and the prosthesis remains in place. The procedure for implanting the bioresorbable Freesolve stent is the same as for the Xience stent. Depending on the usual treatment process of the study physician, the entire procedure will last between 30 and 60 minutes.
(BASEC)
Malattie studiate
Stenosis of the coronary arteries (heart blood vessels)
(BASEC)
- The subject is eligible for the percutaneous transluminal coronary angioplasty (PTCA) intervention. - The subject is an acceptable candidate for aortocoronary bypass surgery. - The subject is eligible for dual antiplatelet therapy (DAPT). (BASEC)
Criteri di esclusione
- The subject presents clinical symptoms and/or electrocardiogram (ECG) changes compatible with a "STEMI" myocardial infarction within 72 hours prior to the study procedure. - The subject has undergone PTCA in the target vessel within the last 12 months prior to the study procedure, or PTCA in another vessel within 72 hours prior to the study procedure. - The subject is on dialysis or has renal insufficiency. (BASEC)
Luogo dello studio
Basilea, Berna, Friburgo, Ginevra, Lugano, Zurigo
(BASEC)
Sponsor
BIOTRONIK AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dimitra Antonopoulou
+41 75 429 5753
dimitra.antonopoulou@clutterbiotronik.comBIOTRONIK AG
(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
07.05.2024
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
BIOMAG-II (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
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
non disponibile
Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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