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)

Recruiting Observational Study
Peripheral Arterial Disease Peripheral Arterial Disease(PAD)
No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Biotronik AG · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Subject ≥18 years old 2. Subject has provided written informed consent 3. Subject has Rutherford classification 2 to 6 4. Reference vessel diameter ≥2 and ≤7 mm 5. Target lesion(s) has stenosis \>70% by visual assessment 6. Multiple consecutive single lesions with a healthy s…
Contacts

Helene Kuissu, PharmD

+41 44 864 54 80

helene.kuissu@biotronik.com

CONTACT