NCT03817801

Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk

Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk: A Randomized, Single-center, Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to investigate whether scoring balloon (non-slip element, NSE) predilation compared to non-compliant (NC) balloon predilation for de novo lesion in patients with high bleeding risk and planning to receive drug-coated balloon (DCB) treatment will lead to lower change in minimal lumen area (MLA) at 6 months by intravascular ultrasound (IVUS).

Detailed description

This is a pilot study that aim to enroll 60 subjects with high bleeding risk. All patients with coronary artery stenosis suitable for DCB treatment will undergo 1:1 randomization either to NSE predilation or NC balloon predilation using a randomization schedule. All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo IVUS before DCB treatment. Data and images will be collected during the index procedure, and at the predefined 6-month IVUS follow-up visit.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	NSE balloon	NSE (Goodman®) predilation + DCB (Sequent® Please) treatment
DEVICE	NC balloon	NC balloon predilation + DCB (Sequent® Please) treatment

Timeline

• Start date: 2019-07-30
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2019-01-28
• Last updated: 2022-04-26

Locations

1 site across 1 country: China