Evaluation of the Clinical Significance of Fluorescence Videoangiography With Indocyanine-Green
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|ClinicalTrials.gov 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
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|
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|
|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|
- Diagnostic Quality of the fluorescence -videoangiography at patients with PAD [ Time Frame: one year ]
- Correlation of the results of fluorescence videoangiography, ankle-brachial-index, i.a. DSA, clinical examination [ Time Frame: one year ]
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 ClinicalTrials.gov identifier (NCT number): NCT00876668
|Principal Investigator:||Thomas Schmitz-Rixen, MD, Professor||Johann Wolfgang Goethe University Hospital|