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New treatment option for Coronary Artery Disease
Official title Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease
ClinicalTrials.gov ID: NCT06567938
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.