Menu
Recruiting NCT06567938

Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease

No phase Interventional Coronary Artery Disease Chronic Kidney Diseases

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: Percutaneous coronary intervention.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Chronic Kidney Diseases. 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
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Intravascular Ultrasound-Guided or Angiography-Guided Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease: The IVUS-CKD Trial

Overview

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

  • Procedure Percutaneous coronary intervention
    PCI with DES implantation

Primary outcome measures

  • Target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR) [Time frame: 12 months]
Secondary outcome measures (10)
  • Hierarchical composite of target vessel failure [Time frame: 12 months]
  • 30-day cardiorenal endpoint [Time frame: 30 days]
  • Target vessel failure excluding periprocedural MI [Time frame: 12 months]
  • Cardiac death [Time frame: 12 months]
  • Target vessel MI [Time frame: 12 months]
  • Clinically driven target vessel revascularization [Time frame: 12 months]
  • Spontaneous MI [Time frame: 12 months]
  • Target lesion failure [Time frame: 12 months]
  • Clinically driven target lesion revascularization [Time frame: 12 months]
  • Major adverse cardiovascular event [Time frame: 12 months]

Eligibility criteria

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

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
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hopital of Xi'an Jiaotong University — Xi'an

Identifiers

NCT: NCT06567938 · HXIIT2024007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗