Imaging-Guided Vessel Sizing in the Tibial Arteries

Peripheral Artery Disease Clinical Trial

— iVEST  

Official title:

Imaging-Guided Vessel Sizing in the Tibial Arteries

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04748965
• Other study ID #: STUDY20210833
• Status: Active, not recruiting
• Start date: August 16, 2021
• Est. completion date: June 9, 2024

Study information

• Verified date: January 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 9, 2024
• Est. primary completion date: June 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Diagnostic Test:
• Digital Subtraction Angiography
Compare optical coherence tomography lesion sizing and characteristics compared to traditional digital subtraction angiography

Locations

Country	Name	City	State
United States	University Hospitals Ahuja Medical Center	Beachwood	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	University Hospitals Parma Medical Center	Parma	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Abbott Medical Devices

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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