Use of Indocyanine Green Angiography in Critical Limb Ischemia (FLUORESCENCE)

Study of Parameters of Infracyanine Angiography as Diagnostic Tool of Critical Limb Ischemia

Investigators conduct a monocentric pilot study with the objective to determine the hemodynamic parameter of fluorescence angiography (slope, amplitude, saturation time ) best correlated with toe pressure in patients with suspicion of critical limb ischemia.

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: fluorescence angiography

Detailed Description

Critical limb ischemia, defined as the presence of chronic ischemic rest pain, ulcers or gangrene attributable to objectively proven arterial occlusive disease, is associated with the appalling prospect that approximately 30% will lose their leg and 25% will die at one year. Despite the progress of therapeutics these statistics haven't changed. Critical limb ischemia is a clinical diagnosis but should be supported by objective tests. None of theses tests (toe blood pressure (TBP), transcutaneous oxygen pressure (TcPO2) and skin perfusion pressure (SPP)) have proven to be enough specific or sensitive, more so they are time consuming, can be subject to several artifacts and may be in some cases discordant making diagnosis difficult. Fluorescence angiography has long been used in ophthalmology for the evaluation of the microcirculation of the retina. Infracyanine remains within the intravascular space allowing the visualization of the vasculature to a depth of 10 mm. With the Fluobeam system, images to a maximal width of 20 cm can be obtained therefore allowing the evaluation of the tissue perfusion of the entire foot.

Method: Fluorescence angiography is performed in the laboratory in the same time as TCPO2, TP and SPP. Infracyanine is injected in an antecubital vein and visualization and signal acquisition carried out using a specific camera device (Fluoptic SAS, France) producing the time course of hemodynamic parameters (slope, amplitude, saturation time).

30patients will be evaluated with correlation between data obtained by fluorescence angiography and too blood pressure

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • Recruiting
    • CHU Grenoble
    • Contact: christophe seinturier; Phone Number: 0033476765547; Email: cseinturier@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with peripheral artery disease and suspicion of critical limb ischemia

Exclusion Criteria:

• pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with suspicion of CLI; patients presenting with peripheral artery disease and suspicion of critical limb ischemia as assessed by TASK II consensus 30 patients will be enrolled and will benefit of measures of TcPO2, too systolic blood pressure and skin perfusion pressure and in the same time angiography with fluorescence (Indocyanine grey 0.05 mg/kg by intravenous injection	Device: fluorescence angiography; Injection of indocyanine grey in an antecubital vein at the posology of 0.05 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation of parameters of fluorescence on time intensity curve ( saturation time (s) with toe pressure (mm hg) assessed by laser doppler	instantaneous, at the time the exam is performed
Correlation of parameters of fluorescence on time intensity curve ( amplitude (UA) with toe pressure (mm hg) assessed by laser doppler	instantaneous, at the time the exam is performed
Correlation of parameters of fluorescence on time intensity curve ( slope) with toe pressure (mm hg) assessed by laser doppler	instantaneous, at the time the exam is performed

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation of parameters of fluorescence on time intensity curve ( saturation time (s) with transcutaneous cutaneous pressure of oxygen (mm Hg)	instantaneous, at the time the exam is performed
Correlation of parameters of fluorescence on time intensity curve ( amplitude (UA) with transcutaneous cutaneous pressure of oxygen (mm Hg)	instantaneous, at the time the exam is performed
Correlation of parameters of fluorescence on time intensity curve (slope) with transcutaneous cutaneous pressure of oxygen (mm Hg)	instantaneous, at the time the exam is performed

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: christophe seinturier, MD, CHU Grenoble France

Publications and helpful links

General Publications

• Schaafsma BE, Mieog JS, Hutteman M, van der Vorst JR, Kuppen PJ, Lowik CW, Frangioni JV, van de Velde CJ, Vahrmeijer AL. The clinical use of indocyanine green as a near-infrared fluorescent contrast agent for image-guided oncologic surgery. J Surg Oncol. 2011 Sep 1;104(3):323-32. doi: 10.1002/jso.21943. Epub 2011 Apr 14.
• Becker F, Robert-Ebadi H, Ricco JB, Setacci C, Cao P, de Donato G, Eckstein HH, De Rango P, Diehm N, Schmidli J, Teraa M, Moll FL, Dick F, Davies AH, Lepantalo M, Apelqvist J. Chapter I: Definitions, epidemiology, clinical presentation and prognosis. Eur J Vasc Endovasc Surg. 2011 Dec;42 Suppl 2:S4-12. doi: 10.1016/S1078-5884(11)60009-9.
• Elsayed S, Clavijo LC. Critical limb ischemia. Cardiol Clin. 2015 Feb;33(1):37-47. doi: 10.1016/j.ccl.2014.09.008.
• Cull DL, Manos G, Hartley MC, Taylor SM, Langan EM, Eidt JF, Johnson BL. An early validation of the Society for Vascular Surgery lower extremity threatened limb classification system. J Vasc Surg. 2014 Dec;60(6):1535-41. doi: 10.1016/j.jvs.2014.08.107. Epub 2014 Oct 3.
• Kannel WB, McGee DL. Update on some epidemiologic features of intermittent claudication: the Framingham Study. J Am Geriatr Soc. 1985 Jan;33(1):13-8. doi: 10.1111/j.1532-5415.1985.tb02853.x.
• Bloch C, Richard JL. [Risk factors for atherosclerotic diseases in the Prospective Parisian Study I. Comparison with foreign studies]. Rev Epidemiol Sante Publique. 1985;33(2):108-20. French.
• Braun JD, Trinidad-Hernandez M, Perry D, Armstrong DG, Mills JL Sr. Early quantitative evaluation of indocyanine green angiography in patients with critical limb ischemia. J Vasc Surg. 2013 May;57(5):1213-8. doi: 10.1016/j.jvs.2012.10.113. Epub 2013 Jan 24.
• Chung J, Modrall JG, Valentine RJ. The need for improved risk stratification in chronic critical limb ischemia. J Vasc Surg. 2014 Dec;60(6):1677-85. doi: 10.1016/j.jvs.2014.07.104. Epub 2014 Sep 8.
• Ciardella AP, Prall FR, Borodoker N, Cunningham ET Jr. Imaging techniques for posterior uveitis. Curr Opin Ophthalmol. 2004 Dec;15(6):519-30. doi: 10.1097/01.icu.0000144386.05116.c5.
• Constans J, Bura-Riviere A. [Lower limb occlusive arterial disease: Diagnosis problems in 2014]. Presse Med. 2014 Jul-Aug;43(7-8):823-6. doi: 10.1016/j.lpm.2014.03.013. Epub 2014 Jun 2. French.
• Terasaki H, Inoue Y, Sugano N, Jibiki M, Kudo T, Lepantalo M, Venermo M. A quantitative method for evaluating local perfusion using indocyanine green fluorescence imaging. Ann Vasc Surg. 2013 Nov;27(8):1154-61. doi: 10.1016/j.avsg.2013.02.011. Epub 2013 Aug 20.
• Igari K, Kudo T, Toyofuku T, Jibiki M, Inoue Y, Kawano T. Quantitative evaluation of the outcomes of revascularization procedures for peripheral arterial disease using indocyanine green angiography. Eur J Vasc Endovasc Surg. 2013 Oct;46(4):460-5. doi: 10.1016/j.ejvs.2013.07.016. Epub 2013 Aug 21.
• Kang Y, Lee J, Kwon K, Choi C. Application of novel dynamic optical imaging for evaluation of peripheral tissue perfusion. Int J Cardiol. 2010 Dec 3;145(3):e99-101. doi: 10.1016/j.ijcard.2008.12.166. Epub 2009 Feb 23.
• Kang Y, Lee J, Kwon K, Choi C. Dynamic fluorescence imaging of indocyanine green for reliable and sensitive diagnosis of peripheral vascular insufficiency. Microvasc Res. 2010 Dec;80(3):552-5. doi: 10.1016/j.mvr.2010.07.004. Epub 2010 Jul 15.
• Labs KH, Dormandy JA, Jaeger KA, Stuerzebecher C, Hiatt WR. Trans-atlantic conference on clinical trial guidelines in PAOD (Peripheral arterial occlusive disease) clinical trial methodology. Eur J Vasc Endovasc Surg. 1999 Sep;18(3):253-65. doi: 10.1053/ejvs.1999.0931. No abstract available.
• Levesque E, Hoti E, Azoulay D, Adam R, Samuel D, Castaing D, Saliba F. Non-invasive ICG-clearance: a useful tool for the management of hepatic artery thrombosis following liver transplantation. Clin Transplant. 2011 Mar-Apr;25(2):297-301. doi: 10.1111/j.1399-0012.2010.01252.x.
• Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
• Pestana IA, Coan B, Erdmann D, Marcus J, Levin LS, Zenn MR. Early experience with fluorescent angiography in free-tissue transfer reconstruction. Plast Reconstr Surg. 2009 Apr;123(4):1239-1244. doi: 10.1097/PRS.0b013e31819e67c1.
• Rashid H, Slim H, Zayed H, Huang DY, Wilkins CJ, Evans DR, Sidhu PS, Edmonds M. The impact of arterial pedal arch quality and angiosome revascularization on foot tissue loss healing and infrapopliteal bypass outcome. J Vasc Surg. 2013 May;57(5):1219-26. doi: 10.1016/j.jvs.2012.10.129. Epub 2013 Mar 21.
• Yamada T, Ohta T, Ishibashi H, Sugimoto I, Iwata H, Takahashi M, Kawanishi J. Clinical reliability and utility of skin perfusion pressure measurement in ischemic limbs--comparison with other noninvasive diagnostic methods. J Vasc Surg. 2008 Feb;47(2):318-23. doi: 10.1016/j.jvs.2007.10.045.
• Zimmermann A, Roenneberg C, Reeps C, Wendorff H, Holzbach T, Eckstein HH. The determination of tissue perfusion and collateralization in peripheral arterial disease with indocyanine green fluorescence angiography. Clin Hemorheol Microcirc. 2012;50(3):157-66. doi: 10.3233/CH-2011-1408.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: June 10, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Actual): March 17, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Ischemia; Angiography; Indocyanine
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 38RC15.212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided