A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis (GAMMA V)
This study has been completed.
First Posted: October 5, 2005
Last Update Posted: April 24, 2008
Information provided by:
The objectives of this study are:
- 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.
- 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.
|Coronary Artery Disease||Device: GAMMA-Iridium-192 catheter||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis (GAMMA V)|
Further study details as provided by Cordis Corporation:
Primary Outcome Measures:
- The primary effectiveness parameters will be late thrombosis of the target lesion at
- 9 months for non-stented patients and late thrombosis of the target lesion at
- 15 months for stented patients.
- The safety criteria will include post-procedure Q-wave myocardial infarction, non-Q-wave myocardial infarction, death, need for bypass surgery, need for emergency bypass surgery,or need for repeat coronary angioplasty.
|Study Start Date:||May 2000|
|Study Completion Date:||June 2006|
Contacts and Locations
No Contacts or Locations Provided