RecruitingNot ApplicableNCT06434194

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)

Sponsor

Cagent Vascular LLC

Enrollment

60 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

Critical Limb Ischemia

Summary

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

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PTA (Standard of Care) and a medical device called Serranator PTA Serration Catheter for people with critical limb ischemia. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 19 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESerranator PTA Serration Catheter

The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.

DRUGPTA (Standard of Care)

A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.

Locations(2)

Columbia University

New York, New York, United States

Weill Cornell Medical

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06434194

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