The Clinical Efficacy and Safety of Drug-coated Balloon

Overview

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.

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

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 1, 2020

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

Patients who received PCI with one or more drug-coated balloons (DCB) Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xijing Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: LingTao, Professor in Cardiology, Director of the department of Cardiology – Xijing Hospital
  • Overall Official(s)
    • Ling Tao, MD, Ph.D., Study Chair, Xijing Hospital
    • Chao Gao, MD, Ph.D., Study Chair, Xijing Hospital

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