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

Sponsor

Johann Wolfgang Goethe University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00876668

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated 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 :

Jun 1, 2007

Actual Primary Completion Date :

Dec 1, 2008

Anticipated Study Completion Date :

Dec 1, 2009

Outcome Measures

Primary Outcome Measures

Diagnostic Quality of the fluorescence -videoangiography at patients with PAD [one year]

Secondary Outcome Measures

Correlation of the results of fluorescence videoangiography, ankle-brachial-index, i.a. DSA, clinical examination [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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