Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Perfo… (NCT06758921) | Clinical Trial Compass
RecruitingNot Applicable
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)
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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
Exclusion criteria
✕. Subject has a single target lesion that involves both ATK and BTK segments.
✕. 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.
✕. History of any open surgical procedure within the past 30 days.
✕. Planned vascular surgery procedure within the next 30 days after the ATK and/or BTK procedure on the target limb.