Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. However, there are still lack of data on procedural outcomes, in-hospital complications, and resource utilization on treatment of (complex) lesions in the femoral, popliteal and infrapopliteal artery in the real-world condition in Europe.
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 the lesions will be considered one lesion.
✓. 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
Exclusion criteria
✕. Subject has a single target lesion that involves both ATK and BTK segment.
✕. 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.
✕. 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. Note: The inflow vessels can be treated on the day of the procedure