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Evaluation of the Clinical Significance of Fluorescence Videoangiography With Indocyanine-Green
This study is ongoing, but not recruiting participants.
First Received: January 16, 2008   Last Updated: April 6, 2009   History of Changes
Sponsored by: Johann Wolfgang Goethe University Hospitals
Information provided by: Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00876668
  Purpose

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.


Condition
Peripheral Vascular Disease
Microcirculation
Ischemia

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases
Drug Information available for: Indocyanine green
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: 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.

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Diagnostic Quality of the fluorescence -videoangiography at patients with PAD [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of the results of fluorescence videoangiography, ankle-brachial-index, i.a. DSA, clinical examination [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 25
Study Start Date: June 2007
Estimated Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with PAD, Rutherford classification II-V, not requiring surgery

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876668

Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Thomas Schmitz-Rixen, MD, Professor Johann Wolfgang Goethe University Hospitals
  More Information

Publications:
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.
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.
Heise M, Krüger 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.
Mothes H, Dönicke 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.
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.
Holm C, Mayr M, Höfter E, Becker A, Pfeiffer UJ, Mühlbauer W. Intraoperative evaluation of skin-flap viability using laser-induced fluorescence of indocyanine green. Br J Plast Surg. 2002 Dec;55(8):635-44.
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. Erratum in: J Vasc Surg 2001 Apr;33(4):805.

Responsible Party: Johann Wolfgang Goethe University Hospitals, Dept. of Vascular Surgery ( Prof. Dr. med. Thomas Schmitz-Rixen )
Study ID Numbers: FLAG II
Study First Received: January 16, 2008
Last Updated: April 6, 2009
ClinicalTrials.gov Identifier: NCT00876668     History of Changes
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Peripheral Vascular diseases
Microcirculation
fluorescence angiography

Study placed in the following topic categories:
Peripheral Vascular Diseases
Vascular Diseases
Ischemia

Additional relevant MeSH terms:
Pathologic Processes
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia

ClinicalTrials.gov processed this record on May 07, 2009