NCT06835127

Ultra-low Dose Contrast for Endovascular Procedures

Feasibility Study of the Use of Ultra-low Dose Iodinated Contrast Agent for Endovascular Procedures in Patients With Chronic Limb-threatening Ischemia and Renal Impairment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Attikon Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Renal Impairment
• Limb Ischemia, Critical

Interventions

Type	Name	Description
PROCEDURE	Infrainguinal 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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-01-23
• Completion: 2026-01-23
• First posted: 2025-02-19
• Last updated: 2026-03-10

Locations

1 site across 1 country: Greece