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ID
Source
Health condition
Peripheral arterial disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peripheral tissue perfusion expressed in drainage ratio of ICG. Drainage ratio is calculated by the fluorescence intensity value 5 minutes after ICG injection divided by the maximal fluorescence value multiplied by 100. We will also measure the Tmax, T1/2 and FT10 (fluorescence intensity value 10 seconds after injection).
Secondary outcome
Correlation between NIR-fluorescence with conventional imaging modalities. To each patient we will measure ankle brachial index and toe pressures. Also, we will compare CT-angiography images with NIR-fluorescence images in patients who have had a CTA within 1 year before present study.
Background summary
Atherosclerosis in major (peripheral) vessels and the subsequent decreased arterial perfusion of extremities can cause ischemic pain, ischemic ulcers and can eventually lead to amputation. At present, Computed Tomography Angiography (CT-A) and X-ray contrast angiography (XA) are the most sensitive diagnostic modalities regarding PAD. While both are well able to diagnose macrovascular occlusive pathologies they lack the ability to adequately assess microvascular (skin) perfusion. This researchproject's focus is to bridge this gap using a promising new diagnostic instrument: NIR fluorescence imaging.
Study objective
Is indocyanine green near infrared fluorescence imaging, using a handheld camera system, able to accurately evaluate and quantify the peripheral tissue perfusion in patients with peripheral arterial disease?
Hypothetically, as indocyanine green goes through microcirculation, and the drainage of ICG is constantly measured by the NIR light camera, the actual tissue perfusion can be accurately quantified in a non-invasive way.
Study design
Inclusion active
Inclusion criteria
Patients diagnosed with peripheral arterial disease(PAD).
Patients planned for percutaneous transluminal angioplasty as a treatment for PAD
Patients planned for bypass surgery as a treatment for PAD
Patients planned for an amputation of a (part of) lower extremity as a treatment for PAD Age 18-80 years old
Exclusion criteria
Allergy or hypersensitivity for natriumiodide, iodium or indocyanine green
Hyperthyroidism or autonomous thyroid adenoma
Pregnancy
Severely impaired liver function
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7531 |
| CCMO | NL65455.058.18 |
| OMON | NL-OMON55609 |