RecruitingNot ApplicableNCT06813534

IVUS Guided PCI in Patients With Chronic Kidney Disease

" Contrast-free " IVUS Guided PCI Compared to Standard Angio-guided PCI in Patient With sEvere kidnEy Disease


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

170 participants

Start Date

Aug 8, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether using a special imaging tool called intravascular ultrasound (IVUS) — a tiny camera placed inside a blood vessel during a heart procedure — improves outcomes for patients with chronic kidney disease (CKD) who need a procedure to open blocked heart arteries (called PCI or angioplasty). Kidney disease patients are at higher risk during these procedures, and researchers want to see if IVUS guidance leads to better, safer results. **You may be eligible if...** - You are over 18 years old - You need a procedure to open a blocked heart artery (PCI) - You have chronic kidney disease with significantly reduced kidney function - Two trained heart specialists have confirmed IVUS can be used safely in your case **You may NOT be eligible if...** - You received iodine contrast dye in the past 72 hours - You have a known allergy to iodine contrast - You are already on permanent dialysis - You have a completely blocked artery (chronic total occlusion) - You are pregnant or breastfeeding - You are in an unstable medical condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntravascular Ultrasound guided PCI

Intra-coronary ultrasound


Locations(2)

Romain GALLET

Créteil, Creteil, France

Romain GALLET

Créteil, France

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NCT06813534


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