NCT06813534 IVUS Guided PCI in Patients With Chronic Kidney Disease
| NCT ID | NCT06813534 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2024-08-08 |
| Primary Completion | 2027-07-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 170 participants in total. It began in 2024-08-08 with a primary completion date of 2027-07-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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"
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06813534 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06813534 currently recruiting?
Yes, NCT06813534 is actively recruiting participants. Contact the research team at romain.gallet@aphp.fr for enrollment information.
Where is the NCT06813534 trial being conducted?
This trial is being conducted at Créteil, France, Créteil, France.
Who is sponsoring the NCT06813534 clinical trial?
NCT06813534 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 170 participants.