IVUS Guided PCI in Patients With Chronic Kidney Disease (SPEED)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Device: Intravascular Ultrasound guided PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT06813534

APHP230196

Details and patient eligibility

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.

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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"

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Conventionnal PCI

Active Comparator group

Description:

Contrast guided PCI

Treatment:

Device: Intravascular Ultrasound guided PCI

IVUS guided PCI

Experimental group

Description:

IVUS guided PCI with iodine contrast injection limited (as much as possible) to a final control injection.

Treatment:

Device: Intravascular Ultrasound guided PCI