Avinger has announced initiation of INSIGHT, a prospective, global, single arm, multicentre study to evaluate the safety and effectiveness of the Pantheris Lumivascular Atherectomy System for treating in-stent restenosis (ISR) in lower extremity arteries.
Up to 140 patients will be enrolled in the INSIGHT trial at up to 20 US and international centres. Sean Janzer, Einstein Medical Center, and Glen Schwartzberg, Baton Rouge General Medical Center, serve as co-principal investigators of the study.
“For many patients experiencing in-stent restenosis, treatment can result in additional harm and costs when other treatment modalities fail to provide the information and precision needed to see and treat the restenosed lesions,” said Janzer. “The Pantheris Lumivascular Atherectomy System has the potential to provide interventionalists with real-time intravascular imaging to more precisely direct plaque excision and avoid interaction with stent struts, leading to better patient outcomes in these often-challenging cases.”
“Minimally invasive treatment of arterial occlusive disease has been limited in its application due to the occurrence of either over or under treatment and the subsequent complications associated with these events,” said Schwartzberg. “The revolutionary concept of real-time imaging of the vessel lumen during an intervention will enhance an environment of safety and improved outcomes in these high-risk patients. This study applies the unique Lumivascular technology to the difficult problem of in-stent restenosis, for which there is no long-term successful treatment.”
“We are pleased to initiate this new trial to gather additional data on the benefits of the Pantheris Lumivascular Atherectomy System and expand its indication for use. I was particularly excited to join Dr Schwartzberg and the welcoming caregivers at Baton Rouge General for the first case of this important study,” said John B Simpson, Avinger’s founder and executive chairman.
Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during a directional atherectomy procedure by using optical coherence tomography (OCT), that is displayed on the Lightbox console. With the Lumivascular approach using real-time OCT image guidance, physicians can more accurately navigate their devices to treat PAD without exposing healthcare workers and patients to the negative effects of ionising radiation.