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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00876668
First received: January 16, 2008
Last updated: April 6, 2009
Last verified: April 2009
  Purpose

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
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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Diagnostic Quality of the fluorescence -videoangiography at patients with PAD [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of the results of fluorescence videoangiography, ankle-brachial-index, i.a. DSA, clinical examination [ Time Frame: one year ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with PAD, Rutherford classification II-V, not requiring surgery

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876668

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

Publications:

Responsible Party: Prof. Dr. med. Thomas Schmitz-Rixen, Johann Wolfgang Goethe University Hospitals, Dept. of Vascular Surgery
ClinicalTrials.gov Identifier: NCT00876668     History of Changes
Other Study ID Numbers: FLAG II
Study First Received: January 16, 2008
Last Updated: April 6, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Peripheral Vascular diseases
Microcirculation
fluorescence angiography

Additional relevant MeSH terms:
Ischemia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 23, 2014