IVUS Guided PCI in Patients With Chronic Kidney Disease
NCT06813534 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170
Last updated 2025-02-07
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.
Conditions
Interventions
- DEVICE
-
Intravascular Ultrasound guided PCI
Intra-coronary ultrasound
Sponsors & Collaborators
-
Assistance Publique - Hôpitaux de Paris
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-08
- Primary Completion
- 2027-07-07
- Completion
- 2027-08-04
Countries
- France
Study Locations
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