Clinipace Worldwide, a global digital clinical research organization (dCRO), announced today that Spectranetics Corporation (Nasdaq: SPNC), a developer, manufacturer, marketer and distributer of single-use medical devices used in minimally invasive procedures within the cardiovascular system, has selected Clinipace to manage all aspects of a pivotal cardiovascular device clinical study that will serve as the basis for 510(k) notice submission.
“With a study as pivotal as this one, we are pleased to drive the credibility and integrity of study results through our dCRO solutions”
Currently there are no medical devices cleared by the FDA to treat patients with in-stent restenosis (ISR) in the peripheral arteries of the leg. Spectranetics' EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis (EXCITE ISR) would be the first FDA cleared solution in the marketplace that addresses the growing concern of this particular segment of peripheral arterial disease.
The study has enrolled its first patient and is expected to grow enrollment up to 353 patients at up to 30 sites in the U.S. The trial will evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis. The primary efficacy endpoint of the trial will be evaluated through six months following the procedure. These results will be included in a 510(k) filing with the FDA.
"With a study as pivotal as this one, we are pleased to drive the credibility and integrity of study results through our dCRO solutions," said Jeff Williams, CEO, Clinipace Worldwide. "We look forward to a long-lasting and successful partnership with Spectranetics as they continue to deliver solutions to unmet needs for patients suffering from peripheral arterial disease."
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