Using ultrasound to guide heart procedures in patients with kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) compared to traditional angiography-guided PCI in patients suffering from chronic kidney disease (CKD). It is a prospective, randomized controlled trial that aims to determine if IVUS guidance can reduce target vessel failure (TVF) rates at 12 months post-procedure. The study involves patients with de novo coronary lesions who meet specific eligibility criteria, including a reduced kidney function. Participants will be monitored for outcomes related to their coronary artery disease and kidney health.

Why it matters

Who can join: the full rules

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

Where it's running

• The First Affiliated Hopital of Xi'an Jiaotong University
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Principal investigator: Ning Guo — The First Affiliated of Xi'an Jiaotong University
• Study coordinator: Ning Guo, PhD,MD
• Email: nguomd@mail.xjtu.edu.cn
• Phone: +86 13991229101

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.