Use of Indocyanine Green Angiography in Critical Limb Ischemia
NCT ID: NCT02820467
Last Updated: 2017-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
30 participants
INTERVENTIONAL
2015-11-30
2017-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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
fluorescence angiography
Injection of indocyanine grey in an antecubital vein at the posology of 0.05 mg/kg
Interventions
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fluorescence angiography
Injection of indocyanine grey in an antecubital vein at the posology of 0.05 mg/kg
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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christophe seinturier, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Grenoble france
Locations
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CHU grenoble
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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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.
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.
Elsayed S, Clavijo LC. Critical limb ischemia. Cardiol Clin. 2015 Feb;33(1):37-47. doi: 10.1016/j.ccl.2014.09.008.
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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.
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.
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.
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Other Identifiers
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38RC15.212
Identifier Type: -
Identifier Source: org_study_id
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