" Contrast-free " IVUS Guided PCI Compared to Standard Angio-guided PCI in Patient With sEvere kidnEy Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Rate of serum creatinine due to nephropathy
研究概览
简要总结
The incidence of contrast-induced nephropathy (CIN) is high (> 25%) in patients with severe chronic renal disease (CKD) who undergo a percutaneous coronary procedure.
The development of CIN is a factor of poor prognosis and is associated with the occurrence of irreversible CKD, the need for dialysis, increased length of stay and hospital costs as well as the risk of death. There is no specific treatment for N-PCI, so its prevention is essential. Although many studies have been conducted to identify, compare and implement different pharmacological strategies for the prevention of CIN before percutaneous coronary procedurse, few per-procedural strategies have been studied to prevent this risk.
Intracoronary ultrasound (IVUS) is an essential tool, used routinely to guide percutaneous coronary procedures thanks to ultrasound, it does not require the injection of iodine contrast.
The main objective is to show that an IVUS-guided "zero-contrast" coronary angioplasty strategy in patients with severe renal impairment decreases the incidence of CIN within 72 hours of procedure.
详细描述
The incidence of contrast-induced nephropathy (CIN) is high (> 25%) in patients with severe chronic renal disease (CKD) who undergo a percutaneous coronary procedure.
The development of CIN is a factor of poor prognosis and is associated with the occurrence of irreversible CKD, the need for dialysis, increased length of stay and hospital costs as well as the risk of death. There is no specific treatment for N-PCI, so its prevention is essential. Although many studies have been conducted to identify, compare and implement different pharmacological strategies for the prevention of CIN before percutaneous coronary procedurse, few per-procedural strategies have been studied to prevent this risk.
Intracoronary ultrasound (IVUS) is an essential tool, used routinely to guide percutaneous coronary procedures thanks to ultrasound, it does not require the injection of iodine contrast.
The main objective is to show that an IVUS-guided "zero-contrast" coronary angioplasty strategy in patients with severe renal impairment decreases the incidence of CIN within 72 hours of procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •Indication for PCI
- •Chronic kidney disease with creatinine clearance ≤ 30 mL/min/1.73m²
- •Feasibility of IVUS determined by 2 trained interventional cardiologist
- •Affiliated to social security
排除标准
- •Iodine contrast injection in the previous 72 hours
- •Known allergy to iodine contrast
- •Permanent dialysis
- •Chronic total occlusion
- •Hemodynamic instability
- •Legal protection
- •Pregnant of breastfeeding patients
- •Patients on "AME"
研究组 & 干预措施
Conventionnal PCI
Contrast guided PCI
干预措施: Intravascular Ultrasound guided PCI (Device)
IVUS guided PCI
IVUS guided PCI with iodine contrast injection limited (as much as possible) to a final control injection.
干预措施: Intravascular Ultrasound guided PCI (Device)
结局指标
主要结局
Rate of serum creatinine due to nephropathy
时间窗: 30 days
Contrast-induced nephropathy is defined as an increase in creatininemia by 25% from its baseline level. The parameter being measured is creatininemia, which refers to the concentration of creatinine in the blood. The unit of measurement for this increase is a percentage (%)
次要结局
- Procedural Criteria(72 hours)
- Global safety(30 days)
- Endocoronary complications(72 hours)
- Myocardial infarction(30 days)
- Global safety : stroke(30 days)
- Angioplasty failures(72 hours)
- Procedural Criteria : Fluoroscopy time(72 hours)
- Procedural Criteria: Air Kerma(72 hours)
- Procedural Criteria : PDS (Procedure Dose Score)(72 hours)