iVEST: Imaging-Guided Vessel Sizing in the Tibial Arteries
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Comparison of Percent Contrast [12 months]
CIL in 100% contrast versus 50% contrast/heparinized saline mixture
- 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)
- Plaque Characteristics: Calcium Depth [12 months]
depth of calcium (micron)
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age >18
-
Patients with presence of Rutherford IV-VI
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Presence of ≥1 tibial artery involvement requiring endovascular treatment
Exclusion Criteria:
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Patients who do not have tibial disease appropriate for intervention
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Estimated glomerular filtration rate <30 mL/min not on hemodialysis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospitals Ahuja Medical Center | Beachwood | Ohio | United States | 44122 |
| 2 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
| 3 | University Hospitals Parma Medical Center | Parma | Ohio | United States | 44129 |
Sponsors and Collaborators
- University Hospitals Cleveland Medical Center
- Abbott Medical Devices
Investigators
- Principal Investigator: Jun Li, MD, University Hospitals Cleveland Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Review.
- 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.
- 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.
- 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.
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