Ireland
--:--IST
Recruiting Not applicable

IVUS Guided PCI in Patients With Chronic Kidney Disease

NCT06813534 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-08-08
Last updated
2025-02-07

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Intravascular Ultrasound guided PCI

Intravascular Ultrasound guided PCI: Intra-coronary ultrasound

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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"

Primary outcome measure(s)

  • Rate of serum creatinine due to nephropathy — 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 (%)

Trial sites (2)

FacilityCityRegionStatus
Romain GALLET Créteil Creteil Not Yet Recruiting
Romain GALLET Créteil France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06813534 on ClinicalTrials.gov ↗ ← All trials in France