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)
Cagent Vascular LLC
60 participants
Oct 31, 2024
INTERVENTIONAL
Conditions
Summary
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
Eligibility
Inclusion Criteria3
- 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 Criteria4
- 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
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Interventions
A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.
The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06434194