Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease (IVUS-CKD)

Xi'an Jiaotong University

Status

Enrolling

Conditions

Chronic Kidney Diseases

Coronary Artery Disease

Treatments

Procedure: Percutaneous coronary intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06567938

HXIIT2024007

Details and patient eligibility

About

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.

Enrollment

1,528 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,528 participants in 2 patient groups

IVUS-guidance PCI

Experimental group

Description:

In the IVUS-guidance group, the optimal stent deployment criteria for non-left main lesion will include the following: : (1) the minimal lumen area (MLA) in the stented segment \> 5.0 mm\^2 or \> 90% of the MLA at the distal reference segments, (2) plaque burden 5 mm proximal or distal to the stent edge is \< 55%, and (3) absence of medial dissection over 3 mm in length. In the setting of a two-stent approach for distal left main bifurcation lesions, the optimal stent deployment criteria are an absolute minimal stent area (MSA) greater than 8 mm\^2 for the left main, greater than 7 mm\^2 for carina, greater than 6 mm\^2 for the ostial or proximal left anterior descending artery, and greater than 5 mm\^2 for the ostial or proximal left circumflex artery. For left main lesion treated with single-stent technique, the criteria are greater than 7mm\^2 for distal and greater than 8mm\^2 for proximal. Further treatment will be required if the criteria are not met.

Treatment:

Procedure: Percutaneous coronary intervention

Angiography-guidance PCI

Active Comparator group

Description:

Angiographic success is defined as thrombolysis in myocardial infarction (TIMI) flow grade 3, and residual stenosis \< 20%.

Treatment:

Procedure: Percutaneous coronary intervention