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Serrantor OCT Study
Recruiting
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)
Who can join
Ages 19 and older · All sexes
Full 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
About the study
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
What is being tested
- Serranator PTA Serration Catheter (device)
- PTA (Standard of Care) (drug)
Sponsor: Cagent Vascular LLC · Participants: 60 · Started: Oct 31, 2024
Contact the study team
- Feeny · Phone: 4197878496
Official record on ClinicalTrials.gov — NCT06434194
Locations in the U.S.
| New York | Columbia University, New York Weill Cornell Medical, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.