Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-01 @ 5:15 AM
Study NCT ID:
NCT00754728
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2008-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"JACTAX" Trial Drug Eluting Stent Trial
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
"JACTAX" Trial Drug Eluting Stent Trial
Status:
COMPLETED
Status Verified Date:
2017-02
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:
Prospective, multi-center, non-randomized registry. 100 patients will be enrolled at up to 10 clinical sites in Europe. The results of this study will be compared to the TAXUS™ ATLAS clinical trial to evaluate the safety of the product.
Detailed Description:
The JACTAX Drug Eluting Stent has been designed to minimize the amount of polymer in contact with the vessel surface, thus potentially reducing the incidence of untoward side effects. The Juxtaposed Ablumenal Coating Process is capable of exclusive coating on the ablumenal side of pre-mounted bare metal stents. Juxtaposed Ablumenal Coating is a proprietary formulation containing a bioerodable polymer. The combination of the Juxtaposed Ablumenal Coating Process and Juxtaposed Ablumenal Coating create a unique microstructure surface, and reduces the amount of required polymer.
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?: