Imaging-Guided Vessel Sizing in the Tibial Arteries (iVEST)

University Hospitals (UH)

Status: Completed

Conditions: Peripheral Artery Disease; Critical Limb Ischemia

Treatments: Diagnostic Test: Digital Subtraction Angiography

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04748965

STUDY20210833

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Tibial Vessel Involvement in Patients with peripheral artery disease and CLI

Description:

The primary goal is to establish a protocol for performing optimal OCT in below-the-knee vessels. OCT images will be analyzed for lesion characteristics, lesion sizing pre- and post-intervention. This will be analyzed against QVA and IVUS (latter if applicable).

Treatment:

Diagnostic Test: Digital Subtraction Angiography