Evaluation of the Clinical Significance of Fluorescence Videoangiography With Indocyanine-Green

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00876668
Recruitment Status : Unknown
Verified April 2009 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 7, 2009
Last Update Posted : April 7, 2009
Information provided by:
Johann Wolfgang Goethe University Hospital

Brief Summary:

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 or disease
Peripheral Vascular Disease Microcirculation Ischemia

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.

Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case Control
Time Perspective: 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.
Study Start Date : June 2007
Actual Primary Completion Date : December 2008
Estimated Study Completion Date : December 2009

Primary Outcome Measures :
  1. Diagnostic Quality of the fluorescence -videoangiography at patients with PAD [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Correlation of the results of fluorescence videoangiography, ankle-brachial-index, i.a. DSA, clinical examination [ Time Frame: one year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with PAD, Rutherford classification II-V, not requiring surgery

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00876668

Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Principal Investigator: Thomas Schmitz-Rixen, MD, Professor Johann Wolfgang Goethe University Hospital

Wölfle KD, Hepp W. "Intraoperative Qualitätssicherung". In: Gefäßchirurgie. Hrsg. Von Hepp W. u. Kogel. München, Jena 2000, S. 117-125

Responsible Party: Prof. Dr. med. Thomas Schmitz-Rixen, Johann Wolfgang Goethe University Hospitals, Dept. of Vascular Surgery Identifier: NCT00876668     History of Changes
Other Study ID Numbers: FLAG II
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: April 7, 2009
Last Verified: April 2009

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

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases