Trial Parameters
Condition Critical Limb Ischemia
Sponsor Cagent Vascular LLC
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 19 Years
Max Age N/A
Start Date 2024-10-31
Completion 2025-06-01
Interventions
Serranator PTA Serration CatheterPTA (Standard of Care)
Brief Summary
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
Eligibility Criteria
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