Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06567938

Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention

Procedure

PCI with DES implantation

Other names: PCI

Primary outcomes

  1. Target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR)

    Time frame: 12 months

    The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography-guidance groups.

Secondary outcomes

  1. Hierarchical composite of target vessel failure

    Time frame: 12 months

    Hierarchical composite of cardiac death, target vessel MI, or clinically driven target vessel revascularization after randomization analyzed by win ratio method.

  2. 30-day cardiorenal endpoint

    Time frame: 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.

  3. Target vessel failure excluding periprocedural MI

    Time frame: 12 months

    The difference will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups.

  4. Cardiac death

    Time frame: 12 months

    Death that could not be attributed to a noncardiac etiology is considered cardiac death.

  5. Target vessel MI

    Time frame: 12 months

  6. Clinically driven target vessel revascularization

    Time frame: 12 months

    Any clinically driven repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.

  7. Spontaneous MI

    Time frame: 12 months

  8. Target lesion failure

    Time frame: 12 months

    A composite of cardiac death, target vessel related MI, or clinically driven target lesion revascularization.

  9. Clinically driven target lesion revascularization

    Time frame: 12 months

  10. Major adverse cardiovascular event

    Time frame: 12 months

    A composite of cardiac death, MI, definite stent thrombosis (ST), or clinically driven TVR

Other outcomes

  1. Renal outcomes

    Time frame: 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.

  2. Annual change in eGFR from baseline

    Time frame: 12 months

    total slope

  3. Clinically relevant bleeding

    Time frame: 12 months

    Bleeding Academic Research Consortium Definition for Bleeding types 2,3 or 5

  4. Major bleeding

    Time frame: 12 months

    Bleeding Academic Research Consortium Definition for Bleeding types 3 or 5

  5. All-cause death

    Time frame: 12 months

  6. Definite or probable stent thrombus (ST)

    Time frame: 12 months

    ST was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC).

  7. Procedure time

    Time frame: during PCI

    From first wire insertion to guide catheter removal.

  8. Radiation exposure

    Time frame: during PCI

    From first wire insertion to guide catheter removal.

  9. Total amount of contrast use

    Time frame: during PCI

    From first wire insertion to guide catheter removal.

Study contacts

Contact information is provided by the study sponsor or research team.

Ning Guo, PhD,MD

CONTACT

[email protected]

+86 13991229101

Xin Huang, PhD,MD

CONTACT

[email protected]

+86 13571961135

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Acronym: IVUS-CKD

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 23, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.