IVUS Guided PCI in Patients With Chronic Kidney Disease

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT06813534

Run by

Assistance Publique - Hôpitaux de Paris

People needed

170

Starts

2024-08-08

Expected to finish

2027-08-04

Last updated by the study team

2025-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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"

Where it is running

• Romain GALLET — Créteil, France (enrolling)
• Romain GALLET — Créteil, Creteil, France

Full record on ClinicalTrials.gov

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