Ra Medical Systems has announced enrolment of the tenth subject in its pivotal clinical trial to evaluate the safety and effectiveness of the Dabra excimer laser system as an atherectomy device for the treatment of peripheral arterial disease (PAD).
“Patient screening and enrolment have recently increased with five clinical sites now cleared to enrol subjects as we pursue an atherectomy indication for Dabra,” said Will McGuire, Ra Medical Systems CEO. “Earlier this year enrolment in this trial had stalled due to the COVID-19 pandemic, which also impacted our ability to activate new clinical sites. We are pleased that nine subjects have been enrolled in the past two months at our clinical study sites, all of which are operating via applicable COVID-19 protocols.”
The open-label pivotal atherectomy clinical trial can enrol up to 100 patients with symptoms of PAD (Rutherford Class 2–5) at up to 10 sites. Outcome measures include safety, acute technical success, and clinical success. The trial’s primary efficacy endpoint is the mean reduction in percent diameter stenosis in each patient’s primary lesion as measured by angiography immediately following treatment with Dabra, before any adjunctive treatment.
The trial’s safety and clinical success endpoints are major adverse events at 30 days and incidence of primary target lesion revascularisation at six months. Dabra received US Food and Drug Administration (FDA) 510(k) clearance in May 2017 for use in ablating a channel in occlusive peripheral vascular disease.