Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00124943
Status:
COMPLETED
Last Update Posted:
2012-04-02
First Post:
2005-07-27
Brief Title:
Use of Nanoparticle Paclitaxel ABI-007 for the Prevention of In-Stent Restenosis
Sponsor:
Celgene Corporation
Organization:
Celgene
Study Overview
Official Title:
A Phase III Safety Trial of Intracoronary Administration of Systemic Nanoparticle Paclitaxel ABI-007 for the Prevention of In-Stent Restenosis
Status:
COMPLETED
Status Verified Date:
2012-03
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:
SNAPIST-III
Brief Summary:
The purpose of this study was to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel ABI-007 for the prevention and reduction of restenosis following de novo stenting or following angioplasty for in-stent restenosis
Detailed Description:
This study consisted of a Phase I non-randomized dose escalation phase to determine the maximum tolerated dose and a randomized Phase II component to assess preliminary efficacy Nanoparticle paclitaxel was administered by intracoronary catheter following either successful and uncomplicated stenting of de novo lesions in native coronary arteries or following successful and uncomplicated balloon angioplasty of instent restenosis ISR lesions
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