A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis (GAMMA V)
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|ClinicalTrials.gov Identifier: NCT00232778|
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : April 24, 2008
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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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: GAMMA-Iridium-192 catheter||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||579 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis (GAMMA V)|
|Study Start Date :||May 2000|
|Actual Study Completion Date :||June 2006|
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.
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