RecruitingNCT06758921

Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)

Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries

Sponsor

Biotronik AG

Enrollment

200 participants

Start Date

Dec 19, 2024

Study Type

OBSERVATIONAL

Conditions

Peripheral Arterial Disease Peripheral Arterial Disease(PAD)

Summary

The purpose of this study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications for endovascular peripheral interventions of femoral, popliteal and infrapopliteal lesions.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Oscar Peripheral Multifunctional Catheter for people with peripheral arterial disease and peripheral arterial disease(pad). The study is currently recruiting participants at 16 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOscar Peripheral Multifunctional Catheter

Oscar Peripheral Multifunctional Catheter encompasses three components: (i) Oscar Support Catheter with integrated Lock Grip, (ii) Oscar Dilator and (iii) Oscar PTA Balloon. Single Oscar PTA Balloon is also available separately and can only be used together with the pre-supplied Oscar Support Catheter as indicated in the compatibility chart in the Instructions for Use (IFU).

Locations(16)

LKH Univ. -Klinikum Graz, Ambulanz für Angiologie

Graz, Austria

Onze Lieve Vrouwziekenhuis

Aalst, Belgium

AZ Saint Blasius

Dendermonde, Belgium

ZOL Ziekenhuis Oost Limburg

Genk, Belgium

University Hospital Ghent

Ghent, Belgium

vzw AZ Groeninge

Kortrijk, Belgium

Hopital Saint Joseph

Paris, France

Karolinen-Hospital Arnsberg

Arnsberg, Germany

Sankt Gertrauden-Krankenhaus

Berlin, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Semmelweis University

Budapest, Hungary

Policlinico Abano Terme

Abano Terme, Italy

Azienda Usl Toscana sud est

Arezzo, Italy

ospedaliero-universitaria Senese

Siena, Italy

Hospital Universitario de Guadalajara

Guadalajara, Spain

Ospedale Regionale civico EOC di Lugano

Lugano, Switzerland

View Full Details on ClinicalTrials.gov

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NCT06758921

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