IVUS Guided PCI in Patients With Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravascular Ultrasound guided PCI.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
" Contrast-free " IVUS Guided PCI Compared to Standard Angio-guided PCI in Patient With sEvere kidnEy Disease
Overview
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.
Interventions
- Device Intravascular Ultrasound guided PCI
Intra-coronary ultrasound
Primary outcome measures
- Rate of serum creatinine due to nephropathy [Time frame: 30 days]
Secondary outcome measures (11)
- Global safety [Time frame: 30 days]
- Endocoronary complications [Time frame: 72 hours]
- Procedural Criteria [Time frame: 72 hours]
- Myocardial infarction [Time frame: 30 days]
- Global safety : stroke [Time frame: 30 days]
- Global safety [Time frame: 30 days]
- Angioplasty failures [Time frame: 72 hours]
- Procedural Criteria : Fluoroscopy time [Time frame: 72 hours]
- Procedural Criteria: Air Kerma [Time frame: 72 hours]
- Procedural Criteria : PDS (Procedure Dose Score) [Time frame: 72 hours]
- Procedural Criteria [Time frame: 72 hours]
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"
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- Romain GALLET — Créteil
- Romain GALLET — Créteil
Identifiers
NCT: NCT06813534 · APHP230196