Chronic Kidney Diseases, Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Chronic Kidney Disease, Percutaneous Coronary Intervention, Intravascular Ultrasound, Randomized Trial
Brief summary
The IVUS-CKD study is a prospective, randomized controlled, multicenter trial to determine whether the intravascular ultrasound (IVUS)-guided percutaneous coronary intervention is superior to the angiography-guidance in chronic kidney disease (CKD) patients with respect to target vessel failure (TVF) at 12 months after randomization.
Interventions
PROCEDUREPercutaneous coronary intervention
PCI with DES implantation
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* CKD patients with eGFR\<60 mL/min/1.73 m\^2 * De novo coronary lesion suitable for second-generation metallic drug-eluting stent placement and IVUS imaging * Signed written informed consent
Exclusion criteria
* Onset of STEMI within 24 hours or emergent angiography * Pregnant or childbearing women * Co-morbidity with an estimated life expectancy of \< 1 year * LVEF ≤ 30% * Cardiogenic shock or hemodynamic instability * Severe hepatic dysfunction, defined as ALT or AST more than 5 times the ULN * PCI within the previous 12 months * Target lesion of stent thrombosis or in-stent restenosis * Any planned non-cardiac surgery within 12 months * Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk * Current enrolment in other clinical trials * Contraindication to anti-platelet agents * History of intracranial or gastrointestinal bleeding requiring transfusion or surgical intervention for control (excluding hemorrhoid) * Chronic total occlusion lesion with unsuccessful guidewire crossing * Current intake of nephrotoxic medications (e.g., nonsteroidal anti-inflammatory drugs except acetylsalicylic acid, phenylbutazone, aminoglycosides, amphotericin B, polymyxin, platinum complexes) * Immune-related kidney disease or on hormone therapy (e.g. lupus nephritis, IgA nephropathy) * Planned exposure to contrast within 72 h after the procedure, intravascular administration of contrast within the previous 5 days * Intake of anticoagulants * Hemoglobin \<60 g/L * Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial * Patients allergic to metals or contrast
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR) | 12 months | The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography-guidance groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day cardiorenal endpoint | 30 days | A composite of contrast-associated acute kidney injury (CA-AKI), requiring specific treatment for acute renal failure, persistent decline in eGFR, MI, or all-cause death. |
| Hierarchical composite of target vessel failure | 12 months | Hierarchical composite of cardiac death, target vessel MI, or clinically driven target vessel revascularization after randomization analyzed by win ratio method. |
| Target vessel failure excluding periprocedural MI | 12 months | The difference will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups. |
| Cardiac death | 12 months | Death that could not be attributed to a noncardiac etiology is considered cardiac death. |
| Target vessel MI | 12 months | — |
| Clinically driven target vessel revascularization | 12 months | Any clinically driven repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion. |
| Spontaneous MI | 12 months | — |
| Target lesion failure | 12 months | A composite of cardiac death, target vessel related MI, or clinically driven target lesion revascularization. |
| Clinically driven target lesion revascularization | 12 months | — |
| Major adverse cardiovascular event | 12 months | A composite of cardiac death, MI, definite stent thrombosis (ST), or clinically driven TVR |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinically relevant bleeding | 12 months | Bleeding Academic Research Consortium Definition for Bleeding types 2，3 or 5 |
| Major bleeding | 12 months | Bleeding Academic Research Consortium Definition for Bleeding types 3 or 5 |
| All-cause death | 12 months | — |
| Definite or probable stent thrombus (ST) | 12 months | ST was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC). |
| Procedure time | during PCI | From first wire insertion to guide catheter removal. |
| Radiation exposure | during PCI | From first wire insertion to guide catheter removal. |
| Total amount of contrast use | during PCI | From first wire insertion to guide catheter removal. |
| Annual change in eGFR from baseline | 12 months | total slope |
| Renal outcomes | 12 months | A composite of requiring specific treatment for acute renal failure (continuous renal replacement therapy, or dialysis), chronic dialysis (peritoneal dialysis, or hemodialysis), persistent decline in eGFR, or renal death. |
Countries
China
Contacts
Primary ContactNing Guo, PhD,MD
Backup ContactXin Huang, PhD,MD
Outcome results
None listed