Clinical and Angiographic Outcomes After Use of Sr-90 Beta Radiation for the Treatment of de novo and restenotic coronary lesions - BETACATH
Description:
Safety and effectiveness of Sr-90 beta radiation vs. placebo in de novo and restenotic lesions in native coronary arteries.
Hypothesis:
Can Sr-90 beta radiation prevent restenosis after angioplasty/stenting?
Study Design
Study Design:
Patients Enrolled: >1400
Mean Follow Up: 8 months
Patient Populations:
single de novo or restenotic lesion reference vessel 2.7-4.0 mm length <20 mm 60-100% diameter stenosis.
Primary Endpoints:
TVR at 8 months
Secondary Endpoints:
Restenosis MLD Late Loss Index at 8 months
Drug/Procedures Used:
Sr-90 beta-radiation brachytherapy versus placebo 14 Gray in vessels between 2.7 and 3.35 mm. 18 Gray in vessels between 3.35 and 4.0 mm.
Principal Findings:
results pending
References:
R Kuntz Late-breaking Trials AHA 2000
Keywords: Beta Particles, Coronary Restenosis, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Brachytherapy
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