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)

RecruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

December 19, 2024

Primary Completion Date

December 20, 2025

Study Completion Date

January 20, 2026

Conditions
Peripheral Arterial DiseasePeripheral Arterial Disease(PAD)
Interventions
DEVICE

Oscar 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)."

Trial Locations (16)

1085

NOT_YET_RECRUITING

Semmelweis University, Budapest

3600

NOT_YET_RECRUITING

ZOL Ziekenhuis Oost Limburg, Genk

6962

NOT_YET_RECRUITING

Ospedale Regionale civico EOC di Lugano, Lugano

8036

RECRUITING

LKH Univ. -Klinikum Graz, Ambulanz für Angiologie, Graz

8500

NOT_YET_RECRUITING

vzw AZ Groeninge, Kortrijk

9000

NOT_YET_RECRUITING

University Hospital Ghent, Ghent

9200

RECRUITING

AZ Saint Blasius, Dendermonde

9300

NOT_YET_RECRUITING

Onze Lieve Vrouwziekenhuis, Aalst

10713

NOT_YET_RECRUITING

Sankt Gertrauden-Krankenhaus, Berlin

19002

NOT_YET_RECRUITING

Hospital Universitario de Guadalajara, Guadalajara

35031

NOT_YET_RECRUITING

Policlinico Abano Terme, Abano Terme

52100

NOT_YET_RECRUITING

Azienda Usl Toscana sud est, Arezzo

53100

NOT_YET_RECRUITING

ospedaliero-universitaria Senese, Siena

59759

NOT_YET_RECRUITING

Karolinen-Hospital Arnsberg, Arnsberg

72076

NOT_YET_RECRUITING

Universitätsklinikum Tübingen, Tübingen

75674

NOT_YET_RECRUITING

Hopital Saint Joseph, Paris

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biotronik AG

INDUSTRY