A clinical study by BIOTRONIK to collect data on the safety and efficacy of the 48-mm long drug-eluting Orsiro Mission Stent for the treatment of patients with stenoses in blood vessels in the heart: BIOFLOW-48
Descrizione riassuntiva dello studio
The aim of the study is to collect data on the safety and efficacy of the 48-mm long Orsiro Mission stent. This stent can treat stenotic lesions ranging from 37 mm to 44 mm in length. The international, multicenter clinical study will be conducted at approximately 35 study centers in Europe and the USA, with up to 150 patients to be included. The outcome of the study will be evaluated based on the target lesion failure (TLF) rate after 12 months. TLF is a rate that consists of cardiac death, myocardial infarction (MI) at the treated target vessel (TV), and the target lesion revascularization (TLR) rate.
(BASEC)
Intervento studiato
Use of the 48-mm long drug-eluting Orsiro Mission Stent in the narrowed section of the coronary artery responsible for the patient's complaints.
(BASEC)
Malattie studiate
The coronary arteries (blood vessels in the heart) have a narrowing that may need to be treated. This narrowing can be caused by deposits on the walls of the arteries (atherosclerosis). As a result, the heart is not sufficiently supplied with oxygen and nutrients, which impairs heart function. This disorder is referred to as stenosis of the coronary arteries and can be the cause of clinical symptoms.
(BASEC)
1. Individuals aged >18 years. 2. Written informed consent from the patient. 3. Subjects with a maximum of two lesions in two different coronary arteries, with only one to be treated with the investigational product. (BASEC)
Criteri di esclusione
1. Pregnant or breastfeeding women or women intending to become pregnant during the study. 2. PCI in the target vessel within the last 12 months or PCI in a non-target vessel within the last 72 hours. 3. Target lesion is a complete occlusion. (BASEC)
Luogo dello studio
Basilea
(BASEC)
Sponsor
BIOTRONIK AG, Bülach CHE
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Doris Lang
+41 75 429 5456
doris.lang@clutterbiotronik.comBIOTONIK AG
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
17.03.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
BIOTRONIK – A Prospective Multicenter Single-Arm Study to Assess the Safety and Effectiveness of the Orsiro Mission 48- mm Sirolimus-Eluting Coronary Stent System for the Treatment of Subjects with Atherosclerotic Lesion(s): BIOFLOW-48 (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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