NCT05133921

The Clinical Efficacy and Safety of Drug-coated Balloon

The Clinical Efficacy and Safety of Drug-coated Balloon in Coronary Lesions: a Real-World, All-Comers ,Single-center, Prospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,487 (actual)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated on the balloon. Treating in-stent restenosis (ISR) with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology (ESC) guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice. Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB in primary large vessels is non-inferior to drug-eluting stent (DES), there is no large-scale RCT or cohort studies to compare the clinical effects of DCB and DES. Despite several theoretical benefits of DCB, the procedural-related complications cannot be entirely prevented, such as acute elastic retraction and severe dissection, which would affect coronary blood flow or lead to acute vascular occlusion. Some studies have suggested that optimization of the procedural technique can reduce the occurrence of complications and target lesion failure in the long-term. Proposed criteria include adapting cutting or scoring balloon for pre-dilatation, residual stenosis\<30% post-DCB, maintaining TIMI flow=3, DCB dilation time\<60s, and appropriate balloon to vessel ratio\> 0.91. However, such proposed technique and criteria have not been evaluated in the real-world clinical practice. This current study is designed to investigate the efficacy and safety of DCB in the real world and exploring the optimal procedural configurations.

Conditions

• Coronary Heart Disease
• Angioplasty, Balloon

Timeline

• Start date: 2015-12-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2021-11-24
• Last updated: 2026-02-12

Locations

1 site across 1 country: China