Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease

NCT ID: NCT06567938

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1528 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Coronary Artery Disease; Chronic Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IVUS-guidance PCI

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.

Group Type: EXPERIMENTAL

Percutaneous coronary intervention

Intervention Type: PROCEDURE

PCI with DES implantation

Angiography-guidance PCI

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

Group Type: ACTIVE_COMPARATOR

Percutaneous coronary intervention

Intervention Type: PROCEDURE

PCI with DES implantation

Interventions

Percutaneous coronary intervention

PCI with DES implantation

Intervention Type: PROCEDURE

Other Intervention Names

PCI

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ning Guo

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated of Xi'an Jiaotong University

Locations

The First Affiliated Hopital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ning Guo, PhD,MD

Role: CONTACT

nguomd@mail.xjtu.edu.cn

+86 13991229101

Xin Huang, PhD,MD

Role: CONTACT

hearthx@126.com

+86 13571961135

Facility Contacts

Ning Guo, PhD,MD

Role: primary

nguomd@mail.xjtu.edu.cn

+86 13991229101

Xin Huang, PhD,MD

Role: backup

hearthx@126.com

+86 13571961135

Other Identifiers

HXIIT2024007

Identifier Type: -

Identifier Source: org_study_id