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)
This trial has no sites in United States.
It has sites in 8 countries. Choose a country to see its sites.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Biotronik AG
- Trial code
- NCT06758921
- Record updated
- 6 January 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Subject ≥18 years old; Subject has provided written informed consent; Subject has Rutherford classification 2 to 6; Reference vessel diameter ≥2 and ≤7 mm; Target lesion(s) has stenosis >70% by visual assessment; Multiple consecutive single lesions with a healthy segment(s) of ≤ 3cm in-between will be considered one lesion; Above the knee (ATK) group:; Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau); At least one below-knee artery patent to the ankle; Successful treatment of inflow iliac stenosis to the target lesion. Inflow lesion stenosis can be treated during the same procedure as per local standard of care. The inflow lesion(s) must be treated first, prior to consideration of treatment of the target lesion. Subject can be enrolled if the inflow lesion(s) are treated and result in ≤30% residual stenosis and no evidence of embolization or significant complications; Below the knee (BTK) group:; Target lesions involve arteries below the tibial plateau; Successful treatment of inflow vessel (from ipsilateral iliac to the target lesion) resulting in ≤30% residual stenosis with no evidence of embolization or significant complications.
Exclusion: Subject not suitable for receiving endovascular procedures of lower limb arteries; Prior planned major amputation in the target limb (i.e., above the ankle); Subject with previous bypass surgery of target vessel; Planned vascular surgery procedure within the next 30 days after the ATK and/or BTK procedure on the target limb; Note: The inflow vessels can be treated on the day of the procedure; Subject currently enrolled in another investigational device, biologic, or drug trial in which the primary endpoint has not yet been reached; History of any open surgical procedure within the past 30 days; Subject has Oscar IFU listed contraindication (such as uncorrected bleeding disorders, sepsis); Subject has a single target lesion that involves both ATK and BTK segments; Subject under dialysis; Subject lacking capacity to provide informed consent; Subject under judicial protection, tutorship, or curatorship (for France only).