Avinger’s Pantheris System Evaluated in INSIGHT for Treating ISR Occlusions in Lower Extremity Arteries

October 6, 2021—The Pantheris optical coherence tomography imaging atherectomy system (Avinger, Inc.) is being studied in the multicenter, prospective, single-arm INSIGHT trial to evaluate the safety and effectiveness of Pantheris to reduce in-stent restenosis (ISR) in vascular stents placed in lower extremity arteries.

Jon George, MD, presented the INSIGHT results during a late-breaking clinical trials session at VIVA 2021, the annual Vascular InterVentional Advances meeting held October 4-7 in Las Vegas, Nevada. An announcement from the VIVA Foundation reported Dr. George’s presentation.

INSIGHT was composed of 97 patients presenting with stent stenosis > 70% who were enrolled at 17 centers. Of these patients, 85 have completed a 6-month follow-up clinic visit and 78 have completed the 1-year follow-up visit.

As summarized by VIVA, the patients in the study had a mean age of 74 years, mean weight of 85.6 kg, and mean height of 165 cm. The patient group was equally male/female and was predominantly Caucasian (78%). Most patients had a history of smoking and were being treated for hypertension, coronary artery disease, and diabetes at the time of enrollment.

The ISR occlusions had a mean length of 13 cm, none to mild calcification, and a mean stenosis of 85% before the procedure.

At VIVA, Dr. George reported the following findings, as assigned by the clinical events committee:

• Freedom from major adverse events was 97% within 30 days postprocedure.
• Freedom from target lesion revascularization was 93% at 6 months postprocedure and 89% at 1 year.
• Ankle-brachial index measures improved by 36% and 39% between baseline and 30 days and 6 months, respectively.
• Patients experienced a 71% improvement (reduction) in Rutherford class by 6 months, with 77% of patients either Rutherford class 0 or 1.
• Stent stenosis was reduced by 82% after treatment, as adjudicated by a central core lab.

The data collected in the INSIGHT trial document a substantial reduction of ISR stenosis, with few adverse events related to use of the Pantheris catheter and measured clinical benefit, concluded Dr. George in the VIVA announcement.