BRITE I

BRITE I

Balloon-Based Radiation Therapy for Treatment of In-Stent Restenosis in Human Coronary Arteries I. A trial measuring outcomes in 32 patients with ischaemia due to in-stent restenosis at 6 months post-intracoronary beta radiation using a novel radioactive design source.
 
Primary endpoints
Major acute coronary events at 6 months.
 
Conclusion
Beta radiation via a balloon 32P source designed for patients with in-stent restenosis results in less angiographic and clinical restenosis, and fewer late complications.
References in periodicals archive ?
Commenting on the procedure, Buchbinder said, "With the in-stent restenosis rate of zero achieved using the RDX(TM) Radiation Delivery Catheter in the BRITE I study, I am very pleased to offer this exciting new treatment to patients who previously had few options.
Jeff Thiel, president and CEO of Radiance commented: "With the results that we have experienced in the BRITE I Trial we are excited about the opportunity to prove the efficacy of the RDX System in a broader clinical trial.
At the American Heart Association meeting in November 2000 Radiance announced the results of the BRITE I trial.
Nasdaq:RADX) Wednesday announced that the results of the BRITE I Clinical Study were presented at the annual American Heart Association (AHA) meeting being held this week in New Orleans.
Independent Angiographic Laboratory Confirms Zero Restenosis in BRITE I Study
Waksman reported that in the 26 patients treated in the BRITE I study, only one patient, or 3.
In combining the BRITE I study patients with in-stent restenosis patients from the company's European BETTER (Beta Radiation Trial to Eliminate Restenosis) Study, in a total of 47 in-stent restenosis patients followed up for six months, a repeat interventional procedure was required in only two patients, or 4.
the Principal Investigator of both the BRITE I and BRITE II Studies said, "The BRITE study utilizing the RDX(TM) Coronary Radiation Delivery System demonstrates the lowest restenosis rate ever reported (3.
Waksman will present a further summary of the BRITE I results at the TCT Plenary Sessions on Saturday, Oct.
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