Serrantor OCT Study

Serranator OCT: Understanding the Mechanism of Action of Serration Angioplasty by Serranator Versus Conventional Balloon Angioplasty for below-the Knee (BTK) Artery Disease Using Optical Coherence Tomography (OCT)

TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.

Inclusion Criteria:

• Rutherford clinical category 4-6 of the target limb
• Age of subjects is >18 years old
• Patients has given informed consent to participate in this study

Exclusion Criteria:

• De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion
• Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries.
• Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm.
• Lesion length less than 220 mm