Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using ultrasound to guide heart procedures in patients with kidney disease

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

Run by Assistance Publique - Hôpitaux de Paris · NCT06813534 · Data updated 2026-11-12

This study is testing whether using ultrasound to guide heart procedures can help people with kidney disease avoid serious complications from traditional methods that use contrast dye.

More Coronary Artery Disease trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment170 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations2 sites (Créteil, Creteil and 1 other locations)
StatusRecruiting
StartedAugust 8, 2024
Main results expectedJuly 7, 2027
Study endsAugust 4, 2027
Registry record updatedFebruary 7, 2025
Trial IDNCT06813534 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults over 18 years old with chronic kidney disease and a creatinine clearance of 30 mL/min or less who require a PCI.

Probably not a fit

Patients who have undergone iodine contrast injection in the previous 72 hours or those on permanent dialysis may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of an intravascular ultrasound (IVUS)-guided approach for performing percutaneous coronary interventions (PCI) in patients suffering from chronic kidney disease (CKD). The focus is on reducing the incidence of contrast-induced nephropathy (CIN), a serious complication that can arise from traditional PCI methods that require iodine contrast. By utilizing a 'zero-contrast' strategy, the study seeks to demonstrate that IVUS can safely guide these procedures without the associated risks of contrast agents. The primary outcome will be the incidence of CIN within 72 hours post-procedure.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of kidney damage in patients with chronic kidney disease undergoing heart procedures.

How similar studies have gone: While many studies have explored pharmacological strategies to prevent CIN, the use of IVUS as a per-procedural strategy in this context is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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"

Where it's running

  • Romain GALLET
    Créteil, France
    Recruiting
  • Romain GALLET
    Créteil, Creteil, France
    Not yet recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.