Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06813534

IVUS Guided PCI in Patients With Chronic Kidney Disease

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-02-07

170

Participants Needed

2

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

IVUS Guided PCI in Patients With Chronic Kidney Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years old
  • Indication for PCI
  • Chronic kidney disease with creatinine clearance 430 mL/min/1.73m
  • Feasibility of IVUS determined by 2 trained interventional cardiologists
  • Affiliated to social security
Not Eligible

You will not qualify if you...

  • Iodine contrast injection in the previous 72 hours
  • Known allergy to iodine contrast
  • Permanent dialysis
  • Chronic total occlusion
  • Hemodynamic instability
  • Legal protection
  • Pregnant or breastfeeding patients
  • Patients on "AME"

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Romain GALLET

Créteil, Creteil, France, 94010

Not Yet Recruiting

2

Romain GALLET

Créteil, France, 94010

Actively Recruiting

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Research Team

R

Romain GALLET, Pr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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IVUS Guided PCI in Patients With Chronic Kidney Disease | DecenTrialz