BD has announced the enrolment of the first patient in the AGILITY investigational device exemption (IDE) study, which will assess the safety and effectiveness of the BD vascular covered stent for the treatment of peripheral arterial disease (PAD).
The investigational vascular covered stent is a self-expanding, low-profile, polytetrafluoroethylene encapsulated nitinol implant. It is deployed from a delivery system that provides controlled stent release.
“When we’re addressing advanced PAD, a self-expanding covered stent can play an important role,” said Sean Lyden (Cleveland Clinic, Cleveland, USA) national principal investigator of the study. “We need a stent that can track to the lesion, opposes the vessel wall and ultimately provides long-term durability. We’re excited to see how this technology performs.”
According to BD, the global, prospective, multicentre, single-arm, non-randomised AGILITY clinical study will include 315 patients at up to 40 clinical study sites across the USA, Europe, Australia and New Zealand. Follow-up for all treated patients will be performed at various points after treatment—starting at one month and ending at 36 months.
“There continues to be significant unmet needs in the treatment of PAD patients,” said Tim Hug, vice president and general manager at BD Peripheral Intervention. “We are excited to have initiated this study and evaluate the treatment benefits of this potentially differentiated technology. This stent could give interventionalists an important new solution in the fight against PAD, expand our portfolio and enable us to better serve our customers and the patients they treat.”
The first patient in the AGILITY study was enrolled at Trinity Medical Center in Bettendorf, USA by Nicolas Shammas, interventional cardiologist and founder and president of the Midwest Cardiovascular Research Foundation.
