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FDA OKs Vascular Architects' clinical trial:

This article was originally published in Clinica

Executive Summary

Vascular Architects has received a conditional approval from the US FDA to begin a multicentre clinical trial to test its aSpire covered stent as a treatment of superficial femoral and popliteal artery stenoses and occlusions. The VALIANT trial is a prospective, non-randomised study that will enrol up to 100 patients at 10 centres. It will assess the San Jose, California firm's stent and controlled expansion delivery system in patients in whom angioplasty has failed or produced suboptimal results. The stent and delivery system is already cleared in the US and in Europe for treating tracheobronchial strictures and peripheral vascular disease, respectively.

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