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Imaging-Guided Vessel Sizing in the Tibial Arteries

NCT04748965 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-05-02

No results posted yet for this study

Summary

This study aims to investigate the utilization of intravascular imaging in treatment of tibial vessels in peripheral artery disease and critical limb ischemia (CLI). The primary goal is to compare optical coherence tomography (OCT) with traditional digital subtraction angiography (DSA) in determining best treatment strategy and vessel optimization, in an effort to improve long term patency and successful wound healing in CLI. Secondary comparison with intravascular ultrasound (IVUS) is undertaken when clinically feasible. The hypothesis is that the adjunctive use of intravascular imaging will affect vessel sizing and anticipated treatment modalities, and therein affect the long term primary patency rates.

Conditions

Interventions

DIAGNOSTIC_TEST

Digital Subtraction Angiography

Compare optical coherence tomography lesion sizing and characteristics compared to traditional digital subtraction angiography

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Jun Li, MD · University Hospitals Cleveland Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-16
Primary Completion
2024-06-09
Completion
2024-06-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04748965 on ClinicalTrials.gov