Ultra-low Dose Contrast for Endovascular Procedures (ULTRA-LOW)

Attikon University Hospital

Status: Active, not recruiting

Conditions: Renal Impairment; Limb Ischemia, Critical

Treatments: Procedure: Infrainguinal peripheral endovascular revascularization

Study type: Observational

Funder types: Other

Identifiers

NCT06835127

ABD126

Details and patient eligibility

About

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.

Full 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).

Enrollment: 18 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

18 participants in 1 patient group

Study cohort

Description:

Patients with renal disease stages 2-4, scheduled to undergo infrainguinal endovascular procedures due to CLTI, using ultra-low dose of iodine contrast media.

Treatment:

Procedure: Infrainguinal peripheral endovascular revascularization