The primary objective is to investigate the feasibility of NIR fluorescence imaging with intra-arterial ICG to detect differences in foot perfusion following successful endovascular lower extremity revascularization.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameter is the difference between quantified fluorescence in
the foot, before - and after the endovascular intervention.
Secondary outcome
- usability score of the technique by vascular surgeon or interventional
radiologist
- correlation between quantified fluorescence parameters, judged effect by
angiography and duplex ultrasound measurement
Background summary
Lower extremity arterial disease (LEAD) is caused by atherosclerosis in the
lower limb, leading to symptoms varying from claudication to ulcer formation.
For patients with advanced stages of LEAD (i.e. wounds or rest pain), a
revascularization procedure is often needed to obtain limb salvage, which is
increasingly being performed with an endovascular intervention. However,
diagnostic methods describing the actual increase in perfusion skin level
remain unknown. Especially for patients with wounds, information about the
increase in perfusion following revascularization might guide revascularization
strategies. Near-infrared fluorescence imaging with intra-arterial indocyanine
green (ICG) has the potential to fill this diagnostic gap of perfusion
assessment.
Study objective
The primary objective is to investigate the feasibility of NIR fluorescence
imaging with intra-arterial ICG to detect differences in foot perfusion
following successful endovascular lower extremity revascularization.
Study design
A single center prospective feasibility study.
Study burden and risks
The risk associated with participation are primarily the (very low) risks of
adverse reactions due to the administration of ICG. Intravenous ICG has been
safely used for over 60 years for different indications. Since the dosage used
in this study is significantly less than the intravenous dosage (1/10), no
additional risk is expected. Patients meeting one or more of the
contraindications for ICG are excluded from this study. No extra blood samples,
physical examinations, questionnaires or other tests will take place.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
1. Adult (>18 years).
2. Rest pain or wounds due to LEAD
3. Scheduled for lower extremity endovascular revascularization.
4. Able to understand the information and implication of participation in the
study.
Exclusion criteria
1. Allergy to ICG, iodine or sodium iodide.
2. Allergy to shellfish.
3. Hyperthyroidism.
4. Autonomous thyroid adenoma.
5. Previous hypersensitivity to ICG.
6. Pregnancy or breastfeeding.
7 Kidney failure (eGFR <10 ml/min/1.73m2).
8. Any condition that the investigator considers to be potentially jeopardizing
the patient*s well-being or the study objectives.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85774.058.23 |