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Joint Clinical Trials Office

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)

Clinical Trial Details

The purpose of this prospective randomized trial is to evaluate the serration angioplasty effect in below the knee arteries with calcified plaque when the Serranator Serration Angioplasty Balloon is used as compared to a conventional balloon angioplasty.

Conventional balloon angioplasty is a regularly used approach. The Serranator Angioplasty Nalloon is U.S. Food and Drug Administration (FDA) approved and commercially available.

Participants will be randomized to receive either the serranator balloon or any commercially available angioplasty balloon (control group).

Enrollment duration is 6-9 months with study visits per standard of care.

Key Eligibility: 
  1. Open to men and women above the age of 18 who have been diagnosed with below the knee calcified artery disease- chronic limb Ischemia (CLTI)

General Exclusion Criteria: 

  1. Participants must not have a known bleeding disorder or uncontrolled hypercoagulable disorder
  2. Participants must not have impaired renal function

Detailed eligibility will be reviewed when you contact the study team

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Rosa Aurora Chu
roc2025@med.cornell.edu

Primary Investigator(s)

Brian DeRubertis, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2405027517

ClinicalTrials.gov:

NCT06434194

Sponsor:

CSP-0679

Status

Open to Enrollment

Age Group

Adult

Sponsor

  • Cagent Vascular

Disease

Chronic Limb-Threatening Ischemia
Surgery