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NCT06567938Recruiting

Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease

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

Source: ClinicalTrials.gov · Last updated 23 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1528 (estimated)
First submitted
10 Jul 2024
Start date
25 Jul 2024
Primary completion date
Jun 2027
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
NCT number
NCT06567938

What you commit to

  • Study type: Interventional
  • Planned participants: 1528
  • From 25 Jul 2024 to the primary completion date, Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • PCI within the previous 12 months
  • Current intake of nephrotoxic medications (e.g., nonsteroidal anti-inflammatory drugs except acetylsalicylic acid, phenylbutazone, aminoglycosides, amphotericin B, polymyxin, platinum complexes)
  • Planned exposure to contrast within 72 h after the procedure, intravascular administration of contrast within the previous 5 days

Other illness

  • Target lesion of stent thrombosis or in-stent restenosis
  • Any planned non-cardiac surgery within 12 months
  • History of intracranial or gastrointestinal bleeding requiring transfusion or surgical intervention for control (excluding hemorrhoid)
  • Immune-related kidney disease or on hormone therapy (e.g. lupus nephritis, IgA nephropathy)
  • Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial
  • Patients allergic to metals or contrast

Lab values

  • LVEF ≤ 30%
  • Severe hepatic dysfunction, defined as ALT or AST more than 5 times the ULN
  • Contraindication to anti-platelet agents
  • Hemoglobin \<60 g/L

Other

  • Onset of STEMI within 24 hours or emergent angiography
  • Pregnant or childbearing women
  • Co-morbidity with an estimated life expectancy of \< 1 year
  • Cardiogenic shock or hemodynamic instability
  • 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
  • Chronic total occlusion lesion with unsuccessful guidewire crossing
  • Intake of anticoagulants

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hopital of Xi'an Jiaotong University
Coordinator of this site? Confirm its status
Xi'anChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.