NCT04748965

Imaging-Guided Vessel Sizing in the Tibial Arteries

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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 and reproducibility in below-the-knee vessels, (b) determine the optimal protocol imaging to produce the optimal clear image frame and clear image length, (c) provide detailed lesion characteristics of tibial disease, (d) assess for luminal gain post-intervention. Operator-determined sizing will be compared against University Hospitals Core Imaging Laboratory assessment of OCT, IVUS (when applicable), and quantitative vessel analysis (QVA). Subjects will follow up per routine care with corresponding ankle-brachial index and toe-brachial index at 1, 3, 6, and 12 months or as clinically indicated. Wound and amputation data will be collected at the pre-procedural visit and with each subsequent visit. Wound care will be managed by our wound care associates in podiatry, vascular medicine, vascular surgery, or plastic surgery.

Conditions

• Peripheral Artery Disease
• Critical Limb Ischemia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Digital Subtraction Angiography	Compare optical coherence tomography lesion sizing and characteristics compared to traditional digital subtraction angiography

Timeline

• Start date: 2021-08-16
• Primary completion: 2024-06-09
• Completion: 2024-06-09
• First posted: 2021-02-10
• Last updated: 2025-05-02

Locations

3 sites across 1 country: United States