IVUS Guided PCI in Patients With Chronic Kidney Disease

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT06813534
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2023-05-09
• Study Start: 2024-08-08
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Primary Completion: 2027-07-07
• Study Completion: 2027-08-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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"

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of serum creatinine due to nephropathy	30 days	Contrast-induced nephropathy is defined as an increase in creatininemia by 25% from its baseline level. The parameter being measured is creatininemia, which refers to the concentration of creatinine in the blood. The unit of measurement for this increase is a percentage (%)

Secondary Outcome Measures

Name	Time	Method
Global safety	30 days	Unplanned hospitalization for cardiac or renal causes: The occurrence of an unplanned hospitalization due to cardiac or renal causes within 30 days. The unit of measurement is the presence or absence of the event, recorded as Yes or No.
Endocoronary complications	72 hours	his includes dissection, thrombus formation, breaches, or coronary occlusion that require an additional unplanned intervention. The unit of measurement is the occurrence of these complications, recorded as Yes or No.
Procedural Criteria	72 hours	Volume of contrast injected: The amount of contrast material used during the procedure. The unit of measurement is milliliters (mL)
Myocardial infarction	30 days	The occurrence of a myocardial infarction within 30 days. The unit of measurement is the presence or absence of the event, recorded as Yes or No."
Global safety : stroke	30 days	Stroke: The occurrence of a stroke within 30 days. The unit of measurement is the presence or absence of the event, recorded as Yes or No
Angioplasty failures	72 hours	Angioplasty failures are defined by a residual stenosis of 70% or greater and/or a TIMI flow of less than 3 at the end of the procedure. The unit of measurement for residual stenosis is percentage (%) and for TIMI flow, the unit is a scale from 0 to 3, with a TIMI flow of less than 3 indicating failure.
Procedural Criteria : Fluoroscopy time	72 hours	Fluoroscopy time: The amount of time fluoroscopy imaging is used during the procedure. The unit of measurement is time, typically recorded in minutes (min)
Procedural Criteria: Air Kerma	72 hours	Air Kerma: A measure of the radiation dose delivered during the procedure. The unit of measurement is the Gray (Gy), specifically milligray (mGy) for this context
Procedural Criteria : PDS (Procedure Dose Score)	72 hours	PDS (Procedure Dose Score): A measure of the total radiation dose delivered to the patient during the procedure. The unit of measurement is arbitrary units based on the specific scoring system used.

Trial Locations

Locations (1)

Romain GALLET; 🇫🇷 Créteil, France