NCT04255043

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	IVUS guidance	IVUS (Boston Scientific®) guidance + DCB (Sequent® Please) treatment
DEVICE	Angiography guidance	DCB (Sequent® Please) treatment

Timeline

• Start date: 2020-02-03
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2020-02-05
• Last updated: 2024-11-15

Locations

1 site across 1 country: China