An observational study to gather information on the safety and effectiveness of the BeFlow Iliac covered stent system in the treatment of patients.
Descrizione riassuntiva dello studio
This study is designed to gather information on the safety and effectiveness of the BeFlow covered iliac stent system, a medical device used to treat obstructions in the iliac arteries (the large blood vessels in the lower abdomen and legs). The device is used to improve blood flow in patients with narrowed or obstructed arteries due to a condition called atherosclerosis or other similar disorders. The primary objective of the study is to evaluate the effectiveness of the BeFlow stent in treating these obstructions and to monitor any risks or side effects over time. The study involves collecting data from patients who have already had the BeFlow stent implanted; this information will then be reviewed to determine the safety and effectiveness of the device. They will be asked to sign an informed consent form, and their progress will be monitored through regular check-ups, including ultrasounds and tests to monitor their health status. The results of this study will help doctors understand the effectiveness of the BeFlow stent and ensure its safety for long-term use in the treatment of arterial obstructions.
(BASEC)
Intervento studiato
Endovascular treatment with the BeFlow covered iliac stent system involves the insertion of a stent (a mesh tube) into the iliac artery to keep the narrowed or obstructed blood vessel open. This helps improve blood flow in the pelvic area and reduces symptoms caused by stenosis (narrowing) of the artery.
(BASEC)
Malattie studiate
Iliac artery stenosis occurs when the blood vessels in the lower abdomen and legs narrow, reducing blood flow. This can cause pain or cramping in the legs, especially when walking, as the muscles do not receive enough blood.
(BASEC)
1. Patients with an indication for permanent intraluminal placement in the iliac arteries to restore and improve patency compromised by atherosclerosis or other stenoses that have been or will be treated with stents, according to the instructions for use of the BeFlow covered iliac stent. 2. The patient is able and willing to sign the informed consent. 3. Patients aged 18 years or older at the time of consent. (BASEC)
Criteri di esclusione
1. Patients with any contraindications listed in the Instructions for Use. 2. Previous stenting in the target vessel. (BASEC)
Luogo dello studio
Lugano
(BASEC)
Sponsor
Bentley InnoMed GmbH Richard Griesbach
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Elien Vernez
+ 32 (0) 52 25 27 45
office@clutterid3medical.comID3 medical
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ticino
(BASEC)
Data di approvazione del comitato etico
01.10.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
An international, multi-centre observational study registry to evaluate safety, performance, and clinical benefit of the BeFlow Iliac Covered Stent System. (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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non disponibile
Endpoint primari e secondari
non disponibile
non disponibile
Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
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
non disponibile