Ignite Creation Date:
2024-05-06 @ 1:26 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04022200
Status:
UNKNOWN
Last Update Posted:
2022-03-22
First Post:
2019-07-14
Brief Title:
Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions
Sponsor:
Beijing Hospital
Organization:
Beijing Hospital
Study Overview
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:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DCB-denovo
Brief 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
Detailed 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 stentDESPaclitaxel 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 therapyDAPT 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 trialBASKET SMALL-2 DCB has been used inoff-labelindications in thereal world for de novo lesions especially in vessels with diameter more than 275mm 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None