NCT06434194NARecruiting
Serrantor OCT Study
Cagent Vascular LLC
Start Date
10/31/2024
Completion Date
6/1/2025
Summary
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
Eligibility Criteria
Age Range: 19 years to No maximum
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
DEVICE
Serranator PTA Serration Catheter
DRUG
PTA (Standard of Care)
Conditions
Critical Limb Ischemia
Locations
Columbia University
New York, New York 10032
United States
Weill Cornell Medical
New York, New York 10065
United States