Intravascular Ultrasound-Guided or Angiography-Guided Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease: The IVUS-CKD Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
The First Affiliated Hopital of Xi'an Jiaotong University
RECRUITING
Xi'an
Contact Information
Primary
Ning Guo, PhD,MD
nguomd@mail.xjtu.edu.cn
+86 13991229101
Backup
Xin Huang, PhD,MD
hearthx@126.com
+86 13571961135
Time Frame
Start Date: 2024-07-25
Estimated Completion Date: 2027-12
Participants
Target number of participants: 1528
Treatments
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.
Active_comparator: Angiography-guidance PCI
Angiographic success is defined as thrombolysis in myocardial infarction (TIMI) flow grade 3, and residual stenosis \< 20%.
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital Xi'an Jiaotong University