Imaging-Guided Vessel Sizing in the Tibial Arteries

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.

Inclusion criteria

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

Exclusion criteria

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