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 ?
has completed enrollment in the BRITE II (Beta Radiation to Reduce In-Stent Restenosis) pivotal clinical study.
Commenting on the activities of the quarter, Jeff Thiel, president & CEO, said: "During the quarter, we continued to focus on follow-up of patients in the BRITE II pivotal study and entered into a definitive merger agreement with Endologix.
As announced in January 2002, Radiance has completed enrollment in the BRITE II trial for the treatment of in-stent restenosis with the RDX, a vascular brachytherapy device.
Nasdaq:RADX) today announced that it has completed enrollment in the BRITE II (Beta Radiation to Reduce In-Stent Restenosis) pivotal clinical study.
Nasdaq:RADX), today announced that it held a BRITE II (Beta Radiation to Reduce In-Stent Restenosis) Study Clinical Investigators Meeting this week in conjunction with the annual American Heart Association (AHA) meeting held in Anaheim, Calif.
trial, BRITE II, in preparation for a PMA filing next year.
Commenting on this decision, Radiance president and CEO, Jeff Thiel said: "We continue to believe that the BRITE II Study results will prove that the RDX System is a superior vascular brachytherapy technology.
The increase in net loss for the second quarter and first six months of 2001, compared with the results for the same periods of 2000, was due primarily to higher spending for clinical trials, including BRITE II and BRITE SVG, and research and development projects including the establishment of a European, third-party manufacturing facility.
Radiance is currently conducting the BRITE II Study in the United States for the treatment of instent restenosis.
BRITE II (Beta Radiation to Reduce In-Stent Restenosis) Study, and expenses associated with the development of its third party European manufacturing facility.
In addition, Thiel is expected to discuss key corporate milestones including the status of the company's BRITE II and BRITE-SVG (Beta Radiation to Reduce In-Stent Restenosis for Saphenous Vein Bypass Grafts) Clinical Studies; the CE-Mark approval process; initiation of human clinical studies in Japan and the upcoming human clinical studies using the RDX Technology in the peripheral vasculature.
Food and Drug Administration ("FDA") approval to use new catheter designs in the BRITE II (Beta Radiation to Reduce In-Stent Restenosis) and BRITE-SVG (Beta Radiation to Reduce In-Stent Restenosis for Saphenous Vein Bypass Grafts) Clinical Studies.