Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for Denovo Lesions in High Bleeding Risk Patients: a Prospective, Multi-center, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- late lumen loss (LLL) at 7 months after procedure
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Junjie Zhang
Vice chief of the department of cardiology
Nanjing First Hospital, Nanjing Medical University
Eligibility Criteria
Inclusion Criteria
- •De novo lesions, suitable for DCB treatment.
- •Patients with high bleeding risk.
Exclusion Criteria
- •Target lesion length \> 15mm.
- •Severe calcified lesions.
- •Left main disease.
- •Ostial lesions.
- •Three-vessel disease.
- •Acute myocardial infarction within 48 hours.
- •Target vessel received stent implantation.
- •Hemodynamic instability.
Outcomes
Primary Outcomes
late lumen loss (LLL) at 7 months after procedure
Time Frame: 7 months
LLL is defined as the difference between postprocedural minimal lumen diameter (MLD) minus MLD at the time of angiographic follow-up
Secondary Outcomes
- Target vessel failure (TVF) at 6 months(6 months)
- bleeding at 6 months(6 months)