An interventional study of IVUS guidance and Angiography guidance in Coronary Artery Disease, sponsored by Nanjing First Hospital, Nanjing Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by Nanjing First Hospital, Nanjing Medical University · Not applicable, Interventional, and Treatment
Drug-coated balloon (DCB) is an alternative choice for denovo lesions in coronary artery disease patients with high bleeding risk. Intravascular ultrasound (IVUS) can provide more details of coronary anatomy and stent implantation, overcoming a number of limitations of coronary angiography. However, the benefit of IVUS-guided DCB treatment has not been investigated. This study is designed to compare IVUS-guided and Angiography-guided DCB treatment for coronary denovo lesions in patients with high bleeding risk.
This is a prospective, multicenter, randomized controlled trial that aims to enroll 260 patients with high bleeding risk.
All patients with coronary denovo lesions suitable for DCB treatment will undergo 1:1 randomization to either IVUS guidance or Angiography guidance using the Central Randomization System.
All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol. Data and images will be collected during the index procedure, and at the predefined 7-month coronary angiography follow-up visit.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 260 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 213 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the IVUS guidance group, IVUS assessment will be used before procedure, post-procedure, and at the follow-up.
Device: IVUS guidance
In the Angiography guidance group, DCB treatment will be guided by routine coronary angiography.
Device: Angiography guidance
IVUS (Boston Scientific®) guidance + DCB (Sequent® Please) treatment
DCB (Sequent® Please) treatment
late lumen loss (LLL) at 7 months after procedure
LLL is defined as the difference between postprocedural minimal lumen diameter (MLD) minus MLD at the time of angiographic follow-up
Time frame: 7 months
Target vessel failure (TVF) at 6 months
TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target-vessel revascularization.
Time frame: 6 months
bleeding at 6 months
bleeding
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Nanjing First Hospital, Nanjing Medical University