BRITE II

BRITE II

Beta Radiation to Reduce In-Stent Restenosis II. A trial evaluating the efficacy of beta radiation via the RDX radiation delivery system for preventing recurrent in-stent restenosis.
 
Primary endpoint
Target vessel revascularisation at 9 months.

Conclusion
Vascular brachytherapy using the RDX system yielded significantly lower rates of restenosis compared with placebo.
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References in periodicals archive ?
(Nasdaq:RADX), Irvine, Calif., has completed enrollment in the BRITE II (Beta Radiation to Reduce In-Stent Restenosis) pivotal clinical study.
The BRITE II study was designed to support a PMA (Pre-Market Approval) filing with the United States Food and Drug Administration.
The BRITE II is a multi-center, randomized study to determine the safety and effectiveness of the RDX Coronary Radiation Delivery System in patients who have had a coronary stent implanted and have returned to the hospital with in-stent restenosis.