Peripheral Artery Disease, Critical Limb Ischemia
Conditions
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 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.
Interventions
DIAGNOSTIC_TESTDigital Subtraction Angiography
Compare optical coherence tomography lesion sizing and characteristics compared to traditional digital subtraction angiography
Sponsors
Abbott Medical Devices
University Hospitals Cleveland Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Technique for OCT Use in the Lower Limb | 12 months | To develop a protocolized, reproducible technique to maximize the Clear Image Length (CIL) on 75 mm pullbacks using 100% contrast in the tibial arteries. The goal is to compare intravascular ultrasound (IVUS) and 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. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vessel Characteristics: Minimal Lumen Area | 12 months | minimal lumen area (mm\^2) |
| Vessel Characteristics: Reference Vessel Diameter | 12 months | reference vessel diameter (mm) |
| Vessel Characteristics: Reference Vessel Area | 12 months | reference vessel area (mm\^2) |
| Vessel Characteristics: Percentage Stenosis | 12 months | percentage stenosis (%) on pre-intervention imaging |
| Plaque Characteristics: Morphology | 12 months | Percentage composition of calcium, fibrous, or lipid plaque (%) |
| Plaque Characteristics: Calcium Arc | 12 months | Calcium arc (degree) |
| Comparison of Percent Contrast | 12 months | CIL in 100% contrast versus 50% contrast/heparinized saline mixture |
| Plaque Characteristics: Fibrous cap | 12 months | depth of fibrous cap (micron) |
| Attenuation | 12 months | Measurement of attenuation coefficient (μ OCT) to quantify the strength of interaction of light and tissue |
| Vessel Characteristics Following Intervention: Luminal Gain | 12 months | Post-intervention luminal gain (%), plaque modification, and dissections |
| Vessel Characteristics Following Intervention: Plaque Modification | 12 months | Reduction in calcium depth (%) if atherectomy is performed |
| Vessel Characteristics Following Intervention: Dissections | 12 months | Qualitative description of dissections seen on post-intervention imaging |
| Plaque Characteristics: Calcium Depth | 12 months | depth of calcium (micron) |
Countries
United States
Outcome results
None listed