Peripheral Arterial Occlusive Disease Atherosclerosis of the leg
Conditions
Interventions
There is no investigational therapeutic intervention. Participants will undergo standard revascularization or amputation procedures as clinically indicated.During the operation, additional imaging wil
Sponsors
Medisch Spectrum Twente (MST)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Scheduled or on the waiting list for a revascularisation or a lower limb amputation procedure in MST Enschede.Rutherford CLI grade = 4.Age = 18 years.Provide informed consent.
Exclusion criteria
Exclusion criteria: Severely impaired renal function (estimated Globular Filtration Rate < 30 ml/min).Known allergy or hypersensitivity for iodine.Hyperthyroidism.Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is clinical success at 6 months after the procedure, defined as:Wound healing in patients presenting with tissue loss (Rutherford categories 5–6), orResolution of ischemic rest pain in patients without tissue loss (Rutherford category 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Perfusion parameters extracted from time-intensity curves that are derived from the NIR fluorescence videos. The parameters are extracted postoperatively in the analysis phase using in-house built software. Trans-Atlantic Inter-Society Consensus (TASC) II scoring of the stenoses/occlusions, before and after intervention. This scoring is based on preoperative CT scans and intraoperative digital subtraction angiography images, and performed by the operating surgeon.Ankle brachial index, systolic blood pressure and toe pressure (all part of regular follow up). | — |
Countries
Netherlands
Contacts
Public ContactH.G.M. Vaassen
Medisch Spectrum Twente (MST)
Outcome results
None listed