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Peripheral Arterial DiseasePhase 3FLUORESCENCENCT02820467

Use of Indocyanine Green Angiography in Critical Limb Ischemia

A Phase 3 study testing fluorescence angiography in people with Peripheral Arterial Disease, run by University Hospital, Grenoble at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
fluorescence angiography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFrance
Study dates
Nov 2015to Aug 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • pregnant women

Trial locations and contacts

1 site in 1 country.

christophe seinturier, MD contact

0033476765547

cseinturier@chu-grenoble.fr

France1 site, 1 recruiting

  • CHU grenoble

    Grenoble

    christophe seinturier, 0033476765547, cseinturier@chu-grenoble.fr

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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

Being tested
fluorescence angiography
Keywords
Indocyanine, Angiography, Ischemia
Medical subject headings
Peripheral Arterial Disease, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fluorescence angiographyDevice

    Injection of indocyanine grey in an antecubital vein at the posology of 0.05 mg/kg

Study groups in NCT02820467
Study groupRoleWhat they receive
patients with suspicion of CLIExperimentalpatients 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
Receives: Device: fluorescence angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation of parameters of fluorescence on time intensity curve ( saturation time (s) with toe pressure (mm hg) assessed by laser doppler

    Measured: instantaneous, at the time the exam is performed

  2. Correlation of parameters of fluorescence on time intensity curve ( amplitude (UA) with toe pressure (mm hg) assessed by laser doppler

    Measured: instantaneous, at the time the exam is performed

  3. Correlation of parameters of fluorescence on time intensity curve ( slope) with toe pressure (mm hg) assessed by laser doppler

    Measured: instantaneous, at the time the exam is performed

Secondary outcomes (3)

  1. Correlation of parameters of fluorescence on time intensity curve ( saturation time (s) with transcutaneous cutaneous pressure of oxygen (mm Hg)

    Measured: instantaneous, at the time the exam is performed

  2. Correlation of parameters of fluorescence on time intensity curve ( amplitude (UA) with transcutaneous cutaneous pressure of oxygen (mm Hg)

    Measured: instantaneous, at the time the exam is performed

  3. Correlation of parameters of fluorescence on time intensity curve (slope) with transcutaneous cutaneous pressure of oxygen (mm Hg)

    Measured: instantaneous, at the time the exam is performed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionAug 2017 (estimated)
  4. Study completionAug 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02820467
Sponsor's protocol ID
38RC15.212
Acronym
FLUORESCENCE
Status last verified
Mar 2017
First submitted
10 Jun 2016
Last updated
17 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22172472

  • 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.

    PubMed 3898252

  • 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.

    PubMed 23352361

  • 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.

    PubMed 25214365

  • 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.

    PubMed 15523198

  • 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.

    PubMed 24890636

  • 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.

    PubMed 25282695

  • Elsayed S, Clavijo LC. Critical limb ischemia. Cardiol Clin. 2015 Feb;33(1):37-47. doi: 10.1016/j.ccl.2014.09.008.

    PubMed 25439329

  • 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.

    PubMed 23972435

  • 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.

    PubMed 23973274

  • 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.

    PubMed 19230993

  • 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.

    PubMed 20637783

  • 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.

    PubMed 3965550

  • 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.

    PubMed 10480800

  • 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.

    PubMed 20412097

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fluorescence angiography in people with Peripheral Arterial Disease, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact christophe seinturier, MD (0033476765547, cseinturier@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation of parameters of fluorescence on time intensity curve ( saturation time (s) with toe pressure (mm hg) assessed by laser doppler (time frame: instantaneous, at the time the exam is performed). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02820467, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.

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