The purpose of this protocol is to study the safety and feasibility of using ultra-low dose iodinated contrast agent for infrainguinal endovascular revascularization procedures in patients with chronic limb-threatening lower limb ischemia (CLTI) and impaired renal function, in the new angiography suite of our department.
Prospective, single-center observational study of patients with CLTI and renal failure but not on dialysis (eGFR \<60ml/minute/1.73m2, renal disease stages 2-4), who are scheduled to undergo endovascular revascularization procedures of the lower limb arteries. The procedures will be performed on the new angiograph of the interventional radiology unit (Philips Azurion 7 b20/15 biplane) and the contrast administration protocol will include 1:9 or 2:9 dilutions of iso-osmotic iodinated contrast agent (Visipaque 320mg/ml) with saline, with the aim of administering the minimum possible amount for the safe and effective performance of the procedure (As Low As Possible; ALARA).
Study Type
OBSERVATIONAL
Enrollment
18
Percutaneous endovascular angioplasty and/or stenting of infrainguinal arteries (femoropopliteal and/or infrapopliteal arteries) under local anesthesia and adjunct mild conscious sedation.
"ATTIKON" University General Hospital, , 1st Rimini St,
Chaïdári, Attica, Greece
Renal function
Assessment of eGFR
Time frame: From the end of the procedure to day 2
Technical success
Successful, uneventful revascularization using less than 15 ml of iodinated contrast media.
Time frame: Day 1
Renal function
Introduction in dialysis
Time frame: 1 month
Limb salvage
Non pre-scheduled above the knee amputation
Time frame: 6 months
Survival
Patients' survival rate
Time frame: 6 months
Re-intervention
Target lesion reintervention (TLR) due to clinical deterioration or relapse of symptoms
Time frame: 6 months
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