critical limb ischemia, diabetes, diabetic foot ulcers
Conditions
Interventions
In this study, we will use the intravascular ultrasound (IVUS) catheter by Philips. The IVUS catheter is a special catheter with s a transducer on one end, to generate sound waves and produce pictures
Sponsors
Haaglanden Medisch Centrum (HMC)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Written informed consent Age: > 18 years old Critical Limb Ischemia, Rutherford category, 5 (minor tissue loss) or 6 (major tissue loss) in the lower legsEndovascular treatable stenosis or occlusions of the crural vessels Referred for below the knee endovascular treatment
Exclusion criteria
Exclusion criteria: Per procedural inability to cross the below the knee arteries stenosis / occlusions.Acute limb ischemiaSub-acute limb ischemia which requires thrombolysis as first treatment modalityPrevious major amputation of the affected limb (at or above the level of the ankle)Previous endovascular or surgical intervention below the knee of the index leg (<6 months ago)Patient unable or unwilling to tolerate standard contrast mediaNot correctable coagulopathy conform HMC protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of procedural decision changes (e.g. different size balloon, stent, prolonged PTA) based on the IVUS analysis after the intervention. We hypothese that in 30% of all cases IVUS will alter procedural decisions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in vessel sizing DSA images compared to IVUS.Differences in technical success (<30% stenosis) in DSA and IVUS, compared to DSA alone (compared to matched cases).Differences in clinical parameters (wound healing and major amputations above ankle) in the patient group with technical success at DSA and IVUS, compared to technical success at DSA only.Additional time for IVUS use during endovascular treatment. | — |
Countries
Netherlands
Contacts
Public ContactJ.M. Baars
Haaglanden Medisch Centrum (HMC)
Outcome results
None listed