Serrantor OCT Study

Cagent Vascular

Status: Enrolling

Conditions: Critical Limb Ischemia

Treatments: Device: Serranator PTA Serration Catheter; Drug: PTA (Standard of Care)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06434194

CSP

Details and patient eligibility

About

TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.

Enrollment: 60 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Serrantor

Active Comparator group

Description:

Subjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon

Treatment:

Device: Serranator PTA Serration Catheter

PTA

Active Comparator group

Description:

Subjects randomized to the PTA Arm of the study will be treated with a standard of care percutaneous transluminal angioplasty (PTA) balloon.

Treatment:

Drug: PTA (Standard of Care)