What this study is
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
What's being tested
- Serranator PTA Serration Catheter
Intervention · DEVICE
The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
- PTA (Standard of Care)
Intervention · DRUG
A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.
Study details
- Official title
- 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)
- Sponsor
- Cagent Vascular LLC
- Conditions
- Critical Limb Ischemia
- Enrolling
- 60 people
- Starts
- 2024-10-31
- Est. completion
- 2025-06-01
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 19 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openColumbia University
New York, New York, United States
- K Dalton · Contact
RecruitingWeill Cornell Medical
New York, New York, United States
- R Chu · Contact
Recruiting
Study team
Sponsor
Cagent Vascular LLC
Study ID CSP
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.