Clinical trial NCT06813534: IVUS Guided PCI in Patients With Chronic Kidney Disease
Official title: " Contrast-free " IVUS Guided PCI Compared to Standard Angio-guided PCI in Patient With sEvere kidnEy Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
chronic kidney disease
Contrast induced nephropathy
IVUS
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study
Primary purpose: OTHER

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.

Detailed description: 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"

Primary outcomes:
measure: Rate of serum creatinine due to nephropathy
timeFrame: 30 days
Secondary outcomes:
measure: Global safety
timeFrame: 30 days
measure: Endocoronary complications
timeFrame: 72 hours
measure: Procedural Criteria
timeFrame: 72 hours
measure: Myocardial infarction
timeFrame: 30 days
measure: Global safety : stroke
timeFrame: 30 days
measure: Global safety
timeFrame: 30 days
measure: Angioplasty failures
timeFrame: 72 hours
measure: Procedural Criteria : Fluoroscopy time
timeFrame: 72 hours
measure: Procedural Criteria: Air Kerma
timeFrame: 72 hours
measure: Procedural Criteria : PDS (Procedure Dose Score)
timeFrame: 72 hours
measure: Procedural Criteria
timeFrame: 72 hours
Other outcomes:
Locations:
city: Créteil
country: France
facility: Romain GALLET
state: Creteil
city: Créteil
country: France
facility: Romain GALLET
Study officials:
References: