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)
Condition(s) studied
Investigational drug(s) / intervention(s)
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).
Study 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
Primary outcome measure(s)
- Oscar Procedural success rate — Index procedure
combination of Oscar technical success and absence of serious procedural complications
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| LKH Univ. -Klinikum Graz, Ambulanz für Angiologie | Graz | Austria | Recruiting |
| Onze Lieve Vrouwziekenhuis | Aalst | Belgium | Not Yet Recruiting |
| AZ Saint Blasius | Dendermonde | Belgium | Recruiting |
| ZOL Ziekenhuis Oost Limburg | Genk | Belgium | Not Yet Recruiting |
| University Hospital Ghent | Ghent | Belgium | Not Yet Recruiting |
| vzw AZ Groeninge | Kortrijk | Belgium | Not Yet Recruiting |
| Hopital Saint Joseph | Paris | France | Not Yet Recruiting |
| Karolinen-Hospital Arnsberg | Arnsberg | Germany | Not Yet Recruiting |
| Sankt Gertrauden-Krankenhaus | Berlin | Germany | Not Yet Recruiting |
| Universitätsklinikum Tübingen | Tübingen | Germany | Not Yet Recruiting |
| Semmelweis University | Budapest | Hungary | Not Yet Recruiting |
| Policlinico Abano Terme | Abano Terme | Italy | Not Yet Recruiting |
| Azienda Usl Toscana sud est | Arezzo | Italy | Not Yet Recruiting |
| ospedaliero-universitaria Senese | Siena | Italy | Not Yet Recruiting |
| Hospital Universitario de Guadalajara | Guadalajara | Spain | Not Yet Recruiting |
| Ospedale Regionale civico EOC di Lugano | Lugano | Switzerland | Not Yet Recruiting |
More Biotronik AG trials in Austria
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06758921 on ClinicalTrials.gov ↗ ← All trials in Austria