IVUS Guided PCI in Patients With Chronic Kidney Disease
NCT ID: NCT06813534
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
170 participants
INTERVENTIONAL
2024-08-08
2027-08-04
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Conventionnal PCI
Contrast guided PCI
Intravascular Ultrasound guided PCI
Intra-coronary ultrasound
IVUS guided PCI
IVUS guided PCI with iodine contrast injection limited (as much as possible) to a final control injection.
Intravascular Ultrasound guided PCI
Intra-coronary ultrasound
Interventions
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Intravascular Ultrasound guided PCI
Intra-coronary ultrasound
Eligibility Criteria
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Inclusion Criteria
* 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
* Known allergy to iodine contrast
* Permanent dialysis
* Chronic total occlusion
* Hemodynamic instability
* Legal protection
* Pregnant of breastfeeding patients
* Patients on "AME"
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Romain GALLET
Créteil, Creteil, France
Romain GALLET
Créteil, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APHP230196
Identifier Type: -
Identifier Source: org_study_id
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