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.
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