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)
Cagent Vascular LLC
Summary
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
Eligibility
- Age range
- 19+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceSerranator PTA Serration Catheter
The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
- DrugPTA (Standard of Care)
A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.
Locations (2)
- Columbia UniversityNew York, New York
- Weill Cornell MedicalNew York, New York