Ignite Creation Date:
2024-05-05 @ 10:23 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01094678
Status:
COMPLETED
Last Update Posted:
2014-09-11
First Post:
2010-03-25
Brief Title:
Zilver PTX Global Registry
Sponsor:
Cook Group Incorporated
Organization:
Cook Group Incorporated
Study Overview
Official Title:
Evaluation of the Safety and Performance of the Zilver PTX Drug-Eluting Stent for Treating De Novo or Restenotic Lesions of the Above-the-knee Femoropopliteal Artery
Status:
COMPLETED
Status Verified Date:
2014-09
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 Zilver PTX Registry Study is a prospective non-randomized open-label multicenter single-arm study enrolling patients in Europe Asia and North America with de novo or restenotic including in-stent restenosis lesions of the above-the-knee femoropopliteal artery SFA The primary endpoint of the study is event-free survival EFS at 6 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 100010 | OTHER | Cook | None |