The Clinical Efficacy and Safety of Drug-coated Balloon

Completed

• Conditions: Angioplasty, Balloon; Coronary Heart Disease

• Registration Number: NCT05133921
• Lead Sponsor: Xijing Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-01
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-11-24
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2487

Inclusion Criteria

1. Patients who received PCI with one or more drug-coated balloons (DCB)
2. Patients who did not received drug-eluting stent implantation

Exclusion Criteria

1. Currently participating in another trial or participants unable to comply to follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-oriented Composite Endpoint (PoCE)	24 months	POCE is a composite clinical endpoint of all-cause death, any stroke, any non-fatal myocardial infarction (MI), any revascularization

Trial Locations

Locations (1)

Ling Tao; 🇨🇳 Xi'an, Shannxi, China