FDA clears Novoste's modified BRAVO trial:
This article was originally published in Clinica
The US FDA has given Novoste the green light to modify a trial of its Corona catheter-based radiation system for treating stenoses in arterial-venous dialysis grafts. Modifications to the trial - a European and US study called BRAVO - will allow physicians to treat patients with thrombosed grafts, which represent a majority of the potential patients, says the Norcross, Georgia firm. They also change the primary endpoint of the trial from a measure of dialysis flow at six months to the absence of reintervention after three months.
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