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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Active, not recruiting
Information provided by:
Johann Wolfgang Goethe University Hospital Identifier:
First received: January 16, 2008
Last updated: April 6, 2009
Last verified: April 2009

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.

Peripheral Vascular Disease Microcirculation Ischemia

Study Type: Observational
Study Design: 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.

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

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

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

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.


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

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

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
Study First Received: January 16, 2008
Last Updated: April 6, 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 processed this record on July 19, 2017