Overview

This trial is active, not recruiting.

Conditions peripheral vascular disease, microcirculation, ischemia
Sponsor Johann Wolfgang Goethe University Hospitals
Start date June 2007
End date December 2008
Trial size 25 participants
Trial identifier NCT00876668, FLAG II

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

Measure
Diagnostic Quality of the fluorescence -videoangiography at patients with PAD
time frame: one year

Secondary Outcomes

Measure
Correlation of the results of fluorescence videoangiography, ankle-brachial-index, i.a. DSA, clinical examination
time frame: one year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Principal investigator Thomas Schmitz-Rixen, MD, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by Johann Wolfgang Goethe University Hospitals.