Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT01850056
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2013-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AcoArt Ⅰ / SFA China
Sponsor:
Acotec Scientific Co., Ltd
Organization:
Study Overview
Official Title:
Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure (AcoArt I Study)
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
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 determine whether DEB is more effective than common PTA balloon in long-term vessel patency and inhibiting restenosis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: