Serrantor OCT Study
ConditionCritical Limb Ischemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorCagent Vascular LLC
About this trial
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Serranator PTA Serration Catheter
- PTA (Standard of Care)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov