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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Chronic Kidney Diseases
• Intervention / Treatment: Procedure: Percutaneous coronary intervention

• Study Type: Interventional
• Enrollment (Estimated): 1528
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ning Guo, PhD,MD; Phone Number: +86 13991229101; Email: nguomd@mail.xjtu.edu.cn
• Study Contact Backup: Name: Xin Huang, PhD,MD; Phone Number: +86 13571961135; Email: hearthx@126.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • The First Affiliated Hopital of Xi'an Jiaotong University
      • Contact: Ning Guo, PhD,MD; Phone Number: +86 13991229101; Email: nguomd@mail.xjtu.edu.cn
      • Contact: Xin Huang, PhD,MD; Phone Number: +86 13571961135; Email: hearthx@126.com
      • Principal Investigator: Ning Guo, PhD,MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Percutaneous coronary intervention; PCI with DES implantation; Other Names: PCI
Active Comparator: Angiography-guidance PCI; Angiographic success is defined as thrombolysis in myocardial infarction (TIMI) flow grade 3, and residual stenosis < 20%.	Procedure: Percutaneous coronary intervention; PCI with DES implantation; Other Names: PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR)	The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography-guidance groups.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hierarchical composite of target vessel failure	Hierarchical composite of cardiac death, target vessel MI, or clinically driven target vessel revascularization after randomization analyzed by win ratio method.	12 months
30-day cardiorenal endpoint	A composite of contrast-associated acute kidney injury (CA-AKI), requiring specific treatment for acute renal failure, persistent decline in eGFR, MI, or all-cause death.	30 days
Target vessel failure excluding periprocedural MI	The difference will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups.	12 months
Cardiac death	Death that could not be attributed to a noncardiac etiology is considered cardiac death.	12 months
Target vessel MI		12 months
Clinically driven target vessel revascularization	Any clinically driven repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.	12 months
Spontaneous MI		12 months
Target lesion failure	A composite of cardiac death, target vessel related MI, or clinically driven target lesion revascularization.	12 months
Clinically driven target lesion revascularization		12 months
Major adverse cardiovascular event	A composite of cardiac death, MI, definite stent thrombosis (ST), or clinically driven TVR	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death		12 months
Renal outcomes	A composite of requiring specific treatment for acute renal failure (continuous renal replacement therapy, or dialysis), chronic dialysis (peritoneal dialysis, or hemodialysis), persistent decline in eGFR, or renal death.	12 months
Annual change in eGFR from baseline	total slope	12 months
Clinically relevant bleeding	Bleeding Academic Research Consortium Definition for Bleeding types 2，3 or 5	12 months
Major bleeding	Bleeding Academic Research Consortium Definition for Bleeding types 3 or 5	12 months
Definite or probable stent thrombus (ST)	ST was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC).	12 months
Procedure time	From first wire insertion to guide catheter removal.	during PCI
Radiation exposure	From first wire insertion to guide catheter removal.	during PCI
Total amount of contrast use	From first wire insertion to guide catheter removal.	during PCI

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Principal Investigator: Ning Guo, The First Affiliated of Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention; Chronic Kidney Disease; Randomized Trial; Intravascular Ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: HXIIT2024007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No