Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232778
Status:
COMPLETED
Last Update Posted:
2008-04-24
First Post:
2005-10-03
Brief Title:
A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis GAMMA V
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis GAMMA V
Status:
COMPLETED
Status Verified Date:
2008-04
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 objectives of this study are
1 To show a reduction in the late thrombosis LT rate following percutaneous revascularization using current interventional techniques with new stent placement and intravascular radiation therapy IRT with a long-term antiplatelet regimen 12 months compared to the stented patients on short-term antiplatelet regimen 2 months from the IRT arm of GAMMA I Trial
2 To show equivalence in the LT rate following percutaneous revascularization using current interventional techniques without new stent placement and IRT with a long-term antiplatelet regimen 6 months compared to non-stented patients on short term antiplatelet therapy 2 months or less from a pooling of the IRT arms of the GAMMA I SCRIPPS and WRIST Trials
1 To show a reduction in the late thrombosis LT rate following percutaneous revascularization using current interventional techniques with new stent placement and intravascular radiation therapy IRT with a long-term antiplatelet regimen 12 months compared to the stented patients on short-term antiplatelet regimen 2 months from the IRT arm of GAMMA I Trial
2 To show equivalence in the LT rate following percutaneous revascularization using current interventional techniques without new stent placement and IRT with a long-term antiplatelet regimen 6 months compared to non-stented patients on short term antiplatelet therapy 2 months or less from a pooling of the IRT arms of the GAMMA I SCRIPPS and WRIST Trials
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