Imaging-Guided Vessel Sizing in the Tibial Arteries

NCT04748965 | Completed

• 1 other identifier: STUDY20210833
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Peripheral Artery Disease; Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Comparison of Percent Contrast

  12 months

• Vessel Characteristics: Minimal Lumen Area

  12 months

• Vessel Characteristics: Reference Vessel Diameter

  12 months

• Vessel Characteristics: Reference Vessel Area

  12 months

• Vessel Characteristics: Percentage Stenosis

  12 months

Study Arms (1)

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

Interventions

Digital Subtraction Angiography DIAGNOSTIC_TEST

Compare optical coherence tomography lesion sizing and characteristics compared to traditional digital subtraction angiography

Tibial Vessel Involvement in Patients with peripheral artery disease and CLI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Abbott Medical Devices: collaborator

Study Sites (3)

University Hospitals Ahuja Medical Center

Beachwood, Ohio, 44122, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

University Hospitals Parma Medical Center

Parma, Ohio, 44129, United States

Location

Related Publications (10)

• 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.

  PMID: 23517833 BACKGROUND

• 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.

  PMID: 24281330 BACKGROUND

• 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.

  PMID: 26242713 BACKGROUND

• 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.

  PMID: 9234107 BACKGROUND

• 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.

  PMID: 20080002 BACKGROUND

• 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.

  PMID: 24595662 BACKGROUND

• 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.

  PMID: 23962439 BACKGROUND

• 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.

  PMID: 23391087 BACKGROUND

• 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.

  PMID: 27012780 BACKGROUND

• 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.

  PMID: 29786411 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Interventions

Angiography, Digital Subtraction

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Radiographic Image Enhancement; Image Enhancement; Photography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Subtraction Technique; Diagnostic Techniques, Cardiovascular

Study Officials

• Jun Li, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2020
• First Posted: February 10, 2021
• Study Start: August 16, 2021
• Primary Completion: June 9, 2024
• Study Completion: June 9, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)