Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04744571
Status:
UNKNOWN
Last Update Posted:
2021-02-09
First Post:
2021-02-01
Brief Title:
Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions
Sponsor:
Beijing Anzhen Hospital
Organization:
Beijing Anzhen Hospital
Study Overview
Official Title:
Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
ENROLLING_BY_INVITATION
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:
None
Brief Summary:
The purpose of this study is to investigate the safety and efficacy of drug-coated balloon angioplasty for the treatment of chronic total occlusions patients with chronic total occlusion CTO lesion
Detailed Description:
Recruited CTO patients will be divided into two groups those undergoing PCI of drug-coated balloon DCB group and those undergoing PCI of drug eluting stent implantation DES group The primary outcome assessed will be the late lumen loss evaluation at a 12-month of follow-up appointment Secondary outcomes include occurrence of major cardiac events MACEs myocardial viability operate success quality of life changes which will be compared to a baseline measurement
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