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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Renal function
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prescheduled infrainguinal revascularization procedure
- •Renal disease stage 2-4 (eGFR <60ml/minute/1.73m2)
- •Adequate pre- and post-procedural hydration protocol
排除标准
- •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
研究组 & 干预措施
Study cohort
Patients with renal disease stages 2-4, scheduled to undergo infrainguinal endovascular procedures due to CLTI, using ultra-low dose of iodine contrast media.
干预措施: Infrainguinal peripheral endovascular revascularization (Procedure)
结局指标
主要结局
Renal function
时间窗: From the end of the procedure to day 2
Assessment of eGFR
Technical success
时间窗: Day 1
Successful, uneventful revascularization using less than 15 ml of iodinated contrast media.
次要结局
- Renal function(1 month)
- Limb salvage(6 months)
- Survival(6 months)
- Re-intervention(6 months)
研究者
Stavros Spiliopoulos
Professor of Interventional Radiology
Attikon Hospital