NCT00232778

A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis (GAMMA V)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 579 (planned)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	GAMMA-Iridium-192 catheter

Timeline

• Start date: 2000-05-01
• Completion: 2006-06-01
• First posted: 2005-10-05
• Last updated: 2008-04-24