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Summary
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
Official title: 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)
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-10-31
Completion Date
2025-06-01
Last Updated
2025-05-18
Healthy Volunteers
No
Conditions
Interventions
Serranator 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.
PTA (Standard of Care)
A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.
Locations (2)
Columbia University
New York, New York, United States
Weill Cornell Medical
New York, New York, United States