Critical limb-threatening ischemia, diabetic foot Critical limb-threatening ischemia, diabetic foot
Conditions
Interventions
The investigational product is the PressureWireTM X Guidewire from Abbott Medical BV. It is a guidewire with an integrated pressure and temperature sensor at the tip to enable measurement of FFR, CMR
Sponsors
Zuyderland
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients of any race or sex, and any age above 18 years, who electively undergo a PTA of the crural vessels Critical limb ischemia defined as Rutherford 4, 5 or 6 [15] Patients with Diabetes Mellitus Patient can provide written informed consent
Exclusion criteria
Exclusion criteria: Acute limb ischemia Complete atrioventricular blockade History of major amputation in the ipsilateral limb History of peripheral bypass surgery in the ipsilateral limb Stenosis or occlusion of the iliofemoral arteries requiring cross-over intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This proof-of-concept study aims to prove the safety and feasibility of CFR and IMR measurements in the crural vessels. Safety is defined as conducting the measurement without complications caused by the device or medication used during the measurements. Feasibility is defined as successfully completing the CFR and IMR measurements during the procedure. The hypothesis is that CFR and IMR measurements are safe and feasible to use in the crural vessels in patients with chronic limb-threatening ischemia of the lower extremities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary to assessing safety and feasibility, this study aims to provide information on the effect of FFR, CFR and IMR on perioperative decision-making regarding surgical endpoint, compared to decisions made solely based on the DSA. Post-procedure, the surgeon will be asked to assess and interpret the additional measurements and decide if they would have made different decisions regarding the procedure. Additionally, the ABI and toe pressures as well as the maximal systolic acceleration of the crural arteries will be measured the day after the procedure to assess changes in blood flow and see if there is improvement shortly after the procedure. This will be compared to clinical outcomes at the postoperative outpatient clinic consultation.Since FFR, CFR and IMR should provide information on macrovascular versus microvascular disease, the values might be able to predict clinical outcomes in terms of wound healing or resolution of rest pain, as well as the risk of reintervention. This will be evaluated at the post-operative outpatient clinic consultation 6 weeks, 6 months and 1 year after the procedure. | — |
Countries
Netherlands
Contacts
Public ContactC. Wely
Zuyderland
Outcome results
None listed