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

Inclusion Criteria5

  • 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 Criteria8

  • 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"

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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