Evaluation of Standard of Care Practices, Procedural Outcomes and In-hospital Complications of Peripheral Endovascular Procedures

Ki vehet részt

• 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 the lesions will be considered one lesion; For Above the knee (ATK) group
• Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)
• At least 1 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; For 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

Ki nem vehet részt

• Subject not suitable for receiving endovascular procedures of lower limb arteries
• Prior planned major amputation in the target limb (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 a single target lesion that involves both ATK and BTK segment
• Subject under dialysis
• Subject lacking capacity to provide informed consent
• Subject under judicial protection, tutorship, or curatorship (for France only)