An observational study to gather information on the safety and effectiveness of the BeFlow Iliac covered stent system in the treatment of patients.
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
1. Patients with any contraindications listed in the Instructions for Use. 2. Previous stenting in the target vessel. (BASEC)
Studienstandort
Lugano
(BASEC)
Sponsor
Bentley InnoMed GmbH Richard Griesbach
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Elien Vernez
+ 32 (0) 52 25 27 45
office@clutterid3medical.comID3 medical
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Tessin
(BASEC)
Datum der Bewilligung durch die Ethikkommission
01.10.2025
(BASEC)
ICTRP Studien-ID
nicht verfügbar
Offizieller Titel (Genehmigt von der Ethikkommission)
An international, multi-centre observational study registry to evaluate safety, performance, and clinical benefit of the BeFlow Iliac Covered Stent System. (BASEC)
Wissenschaftlicher Titel
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Öffentlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Studientyp
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Studiendesign
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Ein-/Ausschlusskriterien
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Primäre und sekundäre Endpunkte
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Registrierungsdatum
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Einschluss des ersten Teilnehmers
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Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
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Weitere Informationen zur Studie
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Ergebnisse der Studie
Zusammenfassung der Ergebnisse
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Link zu den Ergebnissen im Primärregister
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