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)

Sponsor
Biotronik AG
Study ID
NCT06758921
Status
Recruiting
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Conditions

  • Peripheral Arterial Disease
  • Peripheral Arterial Disease(PAD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oscar Peripheral Multifunctional Catheter — DEVICE
    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 Details

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.

Key Dates

First listed
Jan 6, 2025
Start date
Dec 19, 2024
Status verified
Dec 2024
Primary completion
Dec 20, 2025
Completion
Jan 20, 2026

Study Design

Enrollment
200 participants (estimated)

Primary Outcome Measure

Oscar Procedural success rate [ Time Frame: Index procedure ]

Central Contacts

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