Limb Ischemia, Critical, Renal Impairment
Conditions
Keywords
Endovascular procedures, Angioplasty, Stenting, Acute kidney injury
Brief summary
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.
Detailed description
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).
Interventions
PROCEDUREInfrainguinal peripheral endovascular revascularization
Percutaneous endovascular angioplasty and/or stenting of infrainguinal arteries (femoropopliteal and/or infrapopliteal arteries) under local anesthesia and adjunct mild conscious sedation.
Sponsors
Attikon Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* CLTI * Prescheduled infrainguinal revascularization procedure * Renal disease stage 2-4 (eGFR \<60ml/minute/1.73m2) * Adequate pre- and post-procedural hydration protocol
Exclusion criteria
* Inadequate pre- and post-procedural hydration protocol * End-stage renal disease/ dialysis * eGFR \>60ml/minute/1.73m2) * Endovascular treatment of Iliac artery steno-oclussive disease * Allergy to contrast media
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal function | From the end of the procedure to day 2 | Assessment of eGFR |
| Technical success | Day 1 | Successful, uneventful revascularization using less than 15 ml of iodinated contrast media. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal function | 1 month | Introduction in dialysis |
| Limb salvage | 6 months | Non pre-scheduled above the knee amputation |
| Survival | 6 months | Patients' survival rate |
| Re-intervention | 6 months | Target lesion reintervention (TLR) due to clinical deterioration or relapse of symptoms |
Countries
Greece
Contacts
PRINCIPAL_INVESTIGATORStavros C Spiliopoulos, MD, PhD
ATTIKO University Hospital
Outcome results
None listed