Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions — DCB-denovo  

Coronary Disease Clinical Trial

Official title: Long Term Clinical Outcomes of Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions: a Single Center Registry Study

Status Recruiting

Clinical Trial Summary

Drug-coating balloon (DCB) is a new interventional device for treatment of obstructive coronary artery disease (CAD). There is limited data on the long term efficacy and safety of DCB-only strategy for coronary de novo lesions in Asian patients. We therefore carry out this registry study to evaluated the clinical outcomes of paclitaxel DCB in Chinese patients in a real world medical practice.

Clinical Trial Description

DCB has emerged as a new interventional option to treat obstructive CAD. Characterized by non-stent-based local drug delivery system, DCB has several advantages over drug-eluting stent(DES).Paclitaxel DCB inhibits excessive neointimal hyperplasia of a diseased lesions without leaving a permanent metallic frame, therefore reducing the risk of coronary thrombosis and eliminating adverse events associated with stent fracture, allergic reactions to metal struts or polymer. Since only 1 to 3 months duration of dual anti-platelet therapy(DAPT) is required after DCB intervention, the bleeding risk associated with prolonged DAPT is reduced. DCB angioplasty was proved safe in an all-comers, prospective, multicenter registry and confirmed not inferior to DES when treating small coronary lesions in a randomized clinical trial(BASKET SMALL-2). DCB has been used in"off-label"indications in the"real world" for de novo lesions, especially in vessels with diameter more than 2.75mm, and there is limited data on its long term clinical efficacy and safety in Asian patients in contemporary clinical registries. We therefore sought to evaluate the long term clinical outcome of DCB in treatment of coronary de novo lesions in Chinese patients. ;

Related Conditions & MeSH terms

• Coronary Disease

• NCT number: NCT04022200
• Study type: Observational [Patient Registry]
• Source: Beijing Hospital
• Contact: Xue Yu, MD
• Phone: 00861085132266
• Email: yuxuemd@aliyun.com
• Status: Recruiting
• Start date: August 1, 2019
• Completion date: July 31, 2023