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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