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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease; Critical Limb Ischemia
• Intervention / Treatment: Diagnostic test: Digital Subtraction Angiography

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • University Hospitals Ahuja Medical Center
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Parma, Ohio, United States, 44129
      • University Hospitals Parma Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Tibial vessel involvement in patients with underlying peripheral artery disease and critical limb ischemia.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tibial Vessel Involvement in Patients with peripheral artery disease and CLI; 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).	Diagnostic test: Digital Subtraction Angiography; Compare optical coherence tomography lesion sizing and characteristics compared to traditional digital subtraction angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized Technique for OCT Use in the Lower Limb	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Percent Contrast	CIL in 100% contrast versus 50% contrast/heparinized saline mixture	12 months
Vessel Characteristics: Minimal Lumen Area	minimal lumen area (mm^2)	12 months
Vessel Characteristics: Reference Vessel Diameter	reference vessel diameter (mm)	12 months
Vessel Characteristics: Reference Vessel Area	reference vessel area (mm^2)	12 months
Vessel Characteristics: Percentage Stenosis	percentage stenosis (%) on pre-intervention imaging	12 months
Plaque Characteristics: Morphology	Percentage composition of calcium, fibrous, or lipid plaque (%)	12 months
Plaque Characteristics: Calcium Arc	Calcium arc (degree)	12 months
Plaque Characteristics: Calcium Depth	depth of calcium (micron)	12 months
Plaque Characteristics: Fibrous cap	depth of fibrous cap (micron)	12 months
Attenuation	Measurement of attenuation coefficient (μ OCT) to quantify the strength of interaction of light and tissue	12 months
Vessel Characteristics Following Intervention: Luminal Gain	Post-intervention luminal gain (%), plaque modification, and dissections	12 months
Vessel Characteristics Following Intervention: Plaque Modification	Reduction in calcium depth (%) if atherectomy is performed	12 months
Vessel Characteristics Following Intervention: Dissections	Qualitative description of dissections seen on post-intervention imaging	12 months

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Jun Li, MD, University Hospitals Cleveland Medical Center

Publications and helpful links

General Publications

• Wijns W, Shite J, Jones MR, Lee SW, Price MJ, Fabbiocchi F, Barbato E, Akasaka T, Bezerra H, Holmes D. Optical coherence tomography imaging during percutaneous coronary intervention impacts physician decision-making: ILUMIEN I study. Eur Heart J. 2015 Dec 14;36(47):3346-55. doi: 10.1093/eurheartj/ehv367. Epub 2015 Aug 4.
• Bezerra HG, Attizzani GF, Sirbu V, Musumeci G, Lortkipanidze N, Fujino Y, Wang W, Nakamura S, Erglis A, Guagliumi G, Costa MA. Optical coherence tomography versus intravascular ultrasound to evaluate coronary artery disease and percutaneous coronary intervention. JACC Cardiovasc Interv. 2013 Mar;6(3):228-36. doi: 10.1016/j.jcin.2012.09.017.
• Witzenbichler B, Maehara A, Weisz G, Neumann FJ, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Stuckey TD, Mazzaferri EL Jr, Xu K, Parise H, Mehran R, Mintz GS, Stone GW. Relationship between intravascular ultrasound guidance and clinical outcomes after drug-eluting stents: the assessment of dual antiplatelet therapy with drug-eluting stents (ADAPT-DES) study. Circulation. 2014 Jan 28;129(4):463-70. doi: 10.1161/CIRCULATIONAHA.113.003942. Epub 2013 Nov 26.
• Scoccianti M, Verbin CS, Kopchok GE, Back MR, Donayre CE, Sinow RM, White RA. Intravascular ultrasound guidance for peripheral vascular interventions. J Endovasc Surg. 1994 Sep;1:71-80. doi: 10.1583/1074-6218(1994)0012.0.CO;2.
• Arthurs ZM, Bishop PD, Feiten LE, Eagleton MJ, Clair DG, Kashyap VS. Evaluation of peripheral atherosclerosis: a comparative analysis of angiography and intravascular ultrasound imaging. J Vasc Surg. 2010 Apr;51(4):933-8; discussion 939. doi: 10.1016/j.jvs.2009.11.034. Epub 2010 Jan 15.
• Secco GG, Grattoni C, Parisi R, Oshoala K, Cremonesi A, Fattori R, Castriota F. Optical Coherence Tomography Guidance during Peripheral Vascular Intervention. Cardiovasc Intervent Radiol. 2015 Jun;38(3):768-72. doi: 10.1007/s00270-014-0868-3. Epub 2014 Mar 5. No abstract available.
• Eberhardt KM, Treitl M, Boesenecker K, Maxien D, Reiser M, Rieger J. Prospective evaluation of optical coherence tomography in lower limb arteries compared with intravascular ultrasound. J Vasc Interv Radiol. 2013 Oct;24(10):1499-508. doi: 10.1016/j.jvir.2013.06.015. Epub 2013 Aug 17.
• Paraskevopoulos I, Spiliopoulos S, Davlouros P, Karnabatidis D, Katsanos K, Alexopoulos D, Siablis D. Evaluation of below-the-knee drug-eluting stents with frequency-domain optical coherence tomography: neointimal hyperplasia and neoatherosclerosis. J Endovasc Ther. 2013 Feb;20(1):80-93. doi: 10.1583/12-4091.1.
• Agarwal S, Sud K, Shishehbor MH. Nationwide Trends of Hospital Admission and Outcomes Among Critical Limb Ischemia Patients: From 2003-2011. J Am Coll Cardiol. 2016 Apr 26;67(16):1901-13. doi: 10.1016/j.jacc.2016.02.040. Epub 2016 Mar 21.
• Ferraresi R, Mauri G, Losurdo F, Troisi N, Brancaccio D, Caravaggi C, Neri L. BAD transmission and SAD distribution: a new scenario for critical limb ischemia. J Cardiovasc Surg (Torino). 2018 Oct;59(5):655-664. doi: 10.23736/S0021-9509.18.10572-6. Epub 2018 May 22.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): June 9, 2024
• Study Completion (Actual): June 9, 2024

Study Registration Dates

• First Submitted: December 12, 2020
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease
• Other Study ID Numbers: STUDY20210833

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No