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

• Conditions: Peripheral Vascular Disease; Microcirculation; Ischemia

• Registration Number: NCT00876668
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-01-16
• Primary Completion: 2008-12
• Status Verified: 2009-04
• Study First Submitted QC: 2009-04-06
• Last Update Submitted: 2009-04-06
• Study First Posted: 2009-04-07
• Last Update Posted: 2009-04-07
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Quality of the fluorescence -videoangiography at patients with PAD	one year

Secondary Outcome Measures

Name	Time	Method
Correlation of the results of fluorescence videoangiography, ankle-brachial-index, i.a. DSA, clinical examination	one year