Serrantor OCT Study

Description

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

Conditions

Critical Limb Ischemia

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Study Overview

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Study Details

Study overview

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

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)

Serrantor OCT Study

Condition
Critical Limb Ischemia
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University, New York, New York, United States, 10032

New York

Weill Cornell Medical, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

19 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cagent Vascular LLC,

Study Record Dates

2025-06-01