Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon

Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for Denovo Lesions in High Bleeding Risk Patients: a Prospective, Multi-center, Randomized Controlled Trial

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.

Inclusion Criteria:

1. De novo lesions, suitable for DCB treatment.
2. Patients with high bleeding risk.

Exclusion Criteria:

1. Target lesion length > 15mm.
2. Severe calcified lesions.
3. Left main disease.
4. Ostial lesions.
5. Three-vessel disease.
6. Acute myocardial infarction within 48 hours.
7. Target vessel received stent implantation.
8. Hemodynamic instability.