Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-02-13 @ 9:18 AM
Study NCT ID:
NCT02197559
Status:
COMPLETED
Last Update Posted:
2016-10-24
First Post:
2014-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis
Sponsor:
Xuanwu Hospital, Beijing
Organization:
Study Overview
Official Title:
A Prospectie Cohort Study of Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis
Status:
COMPLETED
Status Verified Date:
2014-07
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 study hypothesizes that Drug -eluting stents are more effective in preventing restenosis than Bare-metal stents after Vertebral Artery Ostium stenting
Detailed Description:
The vertebral artery ostium stenosis was one of the higher risk of the ischemia stroke in China. In the mean time ,more and more people accept revascularization. There are no prospective studies for comparison of prevention of restenosis after Drug -eluting stents and Bare-metal stents until now.
The main aim of this study is to observe the following details:
1. Late loss in lumen diameter in follow-up ≥50%
2. Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
3. Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
Secondary endpoint:
brain, gastrointestinal and urinary system bleeding in 12 months follow-up
The main aim of this study is to observe the following details:
1. Late loss in lumen diameter in follow-up ≥50%
2. Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
3. Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
Secondary endpoint:
brain, gastrointestinal and urinary system bleeding in 12 months follow-up
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?: