Peripheral Vascular DiseaseNCT00876668
Evaluation of the Clinical Significance of Fluorescence Videoangiography With Indocyanine-Green
An observational study of Peripheral Vascular Disease and Microcirculation, run by Johann Wolfgang Goethe University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease, Microcirculation, Ischemia
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with PAD, Rutherford classification II-V, not requiring surgery
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
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.
Read the 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.
- Conditions
- Peripheral Vascular Disease, Microcirculation, Ischemia
- Keywords
- Peripheral Vascular diseases, Microcirculation, fluorescence angiography
- Medical subject headings
- Peripheral Vascular Diseases, Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Quality of the fluorescence -videoangiography at patients with PAD
Measured: one year
Secondary outcomes (1)
Correlation of the results of fluorescence videoangiography, ankle-brachial-index, i.a. DSA, clinical examination
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startJun 2007
- Primary completionDec 2008
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Schmitz-Rixen, MD, Professor, Principal investigator, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876668
- Sponsor's protocol ID
- FLAG II
- Status last verified
- Apr 2009
- First submitted
- 16 Jan 2008
- Last updated
- 7 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnson BL, Bandyk DF, Back MR, Avino AJ, Roth SM. Intraoperative duplex monitoring of infrainguinal vein bypass procedures. J Vasc Surg. 2000 Apr;31(4):678-90. doi: 10.1067/mva.2000.104420.
PubMed 10753275Armstrong PA, Bandyk DF, Wilson JS, Shames ML, Johnson BL, Back MR. Optimizing infrainguinal arm vein bypass patency with duplex ultrasound surveillance and endovascular therapy. J Vasc Surg. 2004 Oct;40(4):724-30; discussion 730-1. doi: 10.1016/j.jvs.2004.07.037.
PubMed 15472601Heise M, Kruger U, Settmacher U, Sklenar S, Neuhaus P, Scholz H. A new method of intraoperative hydraulic impedance measurement provides valuable prognostic information about infrainguinal graft patency. J Vasc Surg. 1999 Aug;30(2):301-8. doi: 10.1016/s0741-5214(99)70141-2.
PubMed 10436450Mothes H, Donicke T, Friedel R, Simon M, Markgraf E, Bach O. Indocyanine-green fluorescence video angiography used clinically to evaluate tissue perfusion in microsurgery. J Trauma. 2004 Nov;57(5):1018-24. doi: 10.1097/01.ta.0000123041.47008.70.
PubMed 15580026Raabe A, Beck J, Gerlach R, Zimmermann M, Seifert V. Near-infrared indocyanine green video angiography: a new method for intraoperative assessment of vascular flow. Neurosurgery. 2003 Jan;52(1):132-9; discussion 139. doi: 10.1097/00006123-200301000-00017.
PubMed 12493110Holm C, Mayr M, Hofter E, Becker A, Pfeiffer UJ, Muhlbauer W. Intraoperative evaluation of skin-flap viability using laser-induced fluorescence of indocyanine green. Br J Plast Surg. 2002 Dec;55(8):635-44. doi: 10.1054/bjps.2002.3969.
PubMed 12550116Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4.
PubMed 9308598Wölfle KD, Hepp W. "Intraoperative Qualitätssicherung". In: Gefäßchirurgie. Hrsg. Von Hepp W. u. Kogel. München, Jena 2000, S. 117-125
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00876668
- Acronym / sponsor ID
- FLAG II
- Conditions
- Peripheral Vascular Disease, Microcirculation, Ischemia
- Keywords
- Peripheral Vascular diseases, Microcirculation, fluorescence angiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (estimated)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PAD, Rutherford classification II-V, not requiring surgery
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Patient < 18 years
- Informed consent not signed
- Patient has a MRSA infection
- Patient has an iodine allergy
- Pregnant female Patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Quality of the fluorescence -videoangiography at patients with PAD
Time frame: one year
1 secondary outcome
Correlation of the results of fluorescence videoangiography, ankle-brachial-index, i.a. DSA, clinical examination
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2009.
- Background: PubMed 10753275Johnson BL, Bandyk DF, Back MR, Avino AJ, Roth SM. Intraoperative duplex monitoring of infrainguinal vein bypass procedures. J Vasc Surg. 2000 Apr;31(4):678-90. doi: 10.1067/mva.2000.104420.
- Background: PubMed 15472601Armstrong PA, Bandyk DF, Wilson JS, Shames ML, Johnson BL, Back MR. Optimizing infrainguinal arm vein bypass patency with duplex ultrasound surveillance and endovascular therapy. J Vasc Surg. 2004 Oct;40(4):724-30; discussion 730-1. doi: 10.1016/j.jvs.2004.07.037.
- Background: PubMed 10436450Heise M, Kruger U, Settmacher U, Sklenar S, Neuhaus P, Scholz H. A new method of intraoperative hydraulic impedance measurement provides valuable prognostic information about infrainguinal graft patency. J Vasc Surg. 1999 Aug;30(2):301-8. doi: 10.1016/s0741-5214(99)70141-2.
- Background: PubMed 15580026Mothes H, Donicke T, Friedel R, Simon M, Markgraf E, Bach O. Indocyanine-green fluorescence video angiography used clinically to evaluate tissue perfusion in microsurgery. J Trauma. 2004 Nov;57(5):1018-24. doi: 10.1097/01.ta.0000123041.47008.70.
- Background: PubMed 12493110Raabe A, Beck J, Gerlach R, Zimmermann M, Seifert V. Near-infrared indocyanine green video angiography: a new method for intraoperative assessment of vascular flow. Neurosurgery. 2003 Jan;52(1):132-9; discussion 139. doi: 10.1097/00006123-200301000-00017.
- Background: PubMed 12550116Holm C, Mayr M, Hofter E, Becker A, Pfeiffer UJ, Muhlbauer W. Intraoperative evaluation of skin-flap viability using laser-induced fluorescence of indocyanine green. Br J Plast Surg. 2002 Dec;55(8):635-44. doi: 10.1054/bjps.2002.3969.
- Background: PubMed 9308598Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4.
- BackgroundWölfle KD, Hepp W. "Intraoperative Qualitätssicherung". In: Gefäßchirurgie. Hrsg. Von Hepp W. u. Kogel. München, Jena 2000, S. 117-125
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Schmitz-Rixen, MD, Professor principal investigator
Johann Wolfgang Goethe University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Disease and Microcirculation, run by Johann Wolfgang Goethe University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Quality of the fluorescence -videoangiography at patients with PAD (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00876668, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2009.