- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00876668
Evaluation of the Clinical Significance of Fluorescence Videoangiography With Indocyanine-Green
Pilot-Study to Evaluate the Clinical Significance of the Fluorescence Videoangiography With Indocyanine-Green in Patients With PAD, Rutherford Classification II-V, and Relation to Common Diagnostics.
The aim of the study is to compare the diagnostic value of this non-invasive vascular imaging tool with the established vascular diagnostic methods for PAD in order to get prognostic data.
A higher sensitivity of Fluorescence angiography in order to recognize progression of critical limb ischemia could lead to earlier therapeutic interventions and thereby increase limb salvage. A diagnostic gap would be closed.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Critical limb ischemia (CLI) occurs when the peripheral microcirculation is impaired by arterial stenoses or occlusions. In opposite to earlier studies that only evaluated intermittent claudication due to peripheral arterial disease (PAD), rest pain and trophic changes in the affected extremity are due to reduced microcirculation. Though the main reason for CLI is the existing PAD, many processes responsible for pain and other pad-associated symptoms are triggered by a reduced microcirculation so that attempts to enhance the dermal perfusion by pharmacological or other manipulations may ameliorate the results of vascular treatment. These attempts may be the best options for patients, in which vascular surgery was not successful or primarily impossible.
A Laser-induced fluorescence videoangiography is currently being used in ophthalmology to display the vessels of the eye background. Due to technical improvements, it has become a standard procedure. This trial aims at establishing laser-induced fluorescence videoangiography as standard procedure in vascular surgery. This would be of benefit for the patient as the technique does not require the use of ionising radiation and is possible for patients suffering to renal failure.
Studietyp
Inskrivning (Förväntat)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patient > 18 years
- Chronical ischemia of extremities, Rutherford categories 4, 5 and 6 with indication for vascular reconstruction
- Acute danger of extremity loss due tue ischemia with indication for vascular surgery
Exclusion Criteria:
- Patient < 18 years
- Informed consent not signed
- Patient has a MRSA infection
- Patient has an iodine allergy
- Pregnant female Patient
- Known anaphylactic reactions after injections of contrast media or indocyanine green
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Diagnostic Quality of the fluorescence -videoangiography at patients with PAD
Tidsram: one year
|
one year
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Correlation of the results of fluorescence videoangiography, ankle-brachial-index, i.a. DSA, clinical examination
Tidsram: one year
|
one year
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Thomas Schmitz-Rixen, MD, Professor, Johann Wolfgang Goethe University Hospital
Publikationer och användbara länkar
Allmänna publikationer
- Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4. Erratum In: J Vasc Surg 2001 Apr;33(4):805.
- Johnson BL, Bandyk DF, Back MR, Avino AJ, Roth SM. Intraoperative duplex monitoring of infrainguinal vein bypass procedures. J Vasc Surg. 2000 Apr;31(4):678-90. doi: 10.1067/mva.2000.104420.
- Armstrong PA, Bandyk DF, Wilson JS, Shames ML, Johnson BL, Back MR. Optimizing infrainguinal arm vein bypass patency with duplex ultrasound surveillance and endovascular therapy. J Vasc Surg. 2004 Oct;40(4):724-30; discussion 730-1. doi: 10.1016/j.jvs.2004.07.037.
- Heise M, Kruger U, Settmacher U, Sklenar S, Neuhaus P, Scholz H. A new method of intraoperative hydraulic impedance measurement provides valuable prognostic information about infrainguinal graft patency. J Vasc Surg. 1999 Aug;30(2):301-8. doi: 10.1016/s0741-5214(99)70141-2.
- Mothes H, Donicke T, Friedel R, Simon M, Markgraf E, Bach O. Indocyanine-green fluorescence video angiography used clinically to evaluate tissue perfusion in microsurgery. J Trauma. 2004 Nov;57(5):1018-24. doi: 10.1097/01.ta.0000123041.47008.70.
- Raabe A, Beck J, Gerlach R, Zimmermann M, Seifert V. Near-infrared indocyanine green video angiography: a new method for intraoperative assessment of vascular flow. Neurosurgery. 2003 Jan;52(1):132-9; discussion 139. doi: 10.1097/00006123-200301000-00017.
- Holm C, Mayr M, Hofter E, Becker A, Pfeiffer UJ, Muhlbauer W. Intraoperative evaluation of skin-flap viability using laser-induced fluorescence of indocyanine green. Br J Plast Surg. 2002 Dec;55(8):635-44. doi: 10.1054/bjps.2002.3969.
- Wölfle KD, Hepp W. "Intraoperative Qualitätssicherung". In: Gefäßchirurgie. Hrsg. Von Hepp W. u. Kogel. München, Jena 2000, S. 117-125
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FLAG II
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