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27. 09.2017

SABRE trial published in JACC

Category: News

The SABRE (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis) trial was a prospective, single-arm, feasibility study involving 9 European centers to evaluate the safety and effectiveness of the Virtue balloon for coronary ISR, and powered to demonstrate superiority over (historically documented) plain balloon angioplasty treatment.

Patients were evaluated clinically at 30 days, 6 months, and 1 year. Quantitative coronary angiography (QCA) was performed at the 6-month follow-up visit and analyzed by the independent Cardiovascular Research Foundation core lab (New York, New York). The SABRE trial followed the provisions of the Declaration of Helsinki, informed consent was given by all patients, approvals were obtained from local ethics committees of participating centers and Competent Authorities of participating countries, and operators were trained in the use of the Virtue balloon.

Site management, monitoring, and data management were performed by a contract research organization (genae, Antwerp, Belgium) and clinical data were entered in an electronic database, e-capture.net v.9 (genae) by trained site representatives.

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