The study, which will serve as the basis for 510(k) notice submission, will enroll up to 353 patients across 30 sites in the US.
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 assesed after six months follow up.
The results will be included in a 510(k) filing with the US Food and Drug Administration (FDA).
Clinipace CEO Jeff Williams said they look forward to a partnership with Spectranetics as they continue to deliver solutions to unmet needs for patients suffering from peripheral arterial disease.
