Status:

COMPLETED

Imaging-Guided Vessel Sizing in the Tibial Arteries

Lead Sponsor:

University Hospitals Cleveland Medical Center

Collaborating Sponsors:

Abbott Medical Devices

Conditions:

Peripheral Artery Disease

Critical Limb Ischemia

Eligibility:

All Genders

18+ years

Brief 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 opt...

Detailed Description

This is a prospective, nonrandomized trial to investigate the adjunctive use of intravascular imaging in tibial vessel interventions. The evaluation of OCT is primarily to: (a) establish feasibility a...

Eligibility Criteria

Inclusion

  • Age \>18
  • Patients with presence of Rutherford IV-VI
  • Presence of ≥1 tibial artery involvement requiring endovascular treatment

Exclusion

  • Patients who do not have tibial disease appropriate for intervention
  • Estimated glomerular filtration rate \<30 mL/min not on hemodialysis

Key Trial Info

Start Date :

August 16 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 9 2024

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT04748965

Start Date

August 16 2021

End Date

June 9 2024

Last Update

May 2 2025

Active Locations (3)

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Page 1 of 1 (3 locations)

1

University Hospitals Ahuja Medical Center

Beachwood, Ohio, United States, 44122

2

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

3

University Hospitals Parma Medical Center

Parma, Ohio, United States, 44129