Avinger Announces Interim 6-Month VISION Trial Results

October 13, 2015—Avinger, Inc. announced that interim 6-month results for its VISION clinical trial were presented at TCT 2015, the Transcatheter Cardiovascular Therapeutics scientific symposium being held October 11–15 in San Francisco, California. Principal Investigator Arne Schwindt, MD, from St. Franziskus Hospital in Münster, Germany, presented the data.

VISION is a nonrandomized, prospective, global, single-arm clinical trial that is evaluating the safety and effectiveness of the Pantheris system to perform directional atherectomy, while using intravascular high-resolution optical coherence tomography intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. The study enrolled 134 patients and includes follow-up data collection review by independent third parties at 30 days and 6 months.

The 6-month results presented at TCT were from an interim analysis of 93 of the 130 patients treated per protocol in the study. Data from this interim cohort was the basis for the 510(k) application for Pantheris that the company submitted to the US Food and Drug Administration on August 12, 2015. Avinger anticipates that 6-month data from all 130 patients will be presented at a major medical meeting in November 2015.

According to the company, the VISION results demonstrate successful achievement of all primary and secondary safety and effectiveness endpoints. The primary safety endpoint, related to incidence of major adverse events, was 21.5% in the 93-patient interim cohort, measuring below the predefined study limit of 43.2%. 

The safety results include zero Pantheris-related dissections or perforations across all lesions treated. Importantly, the interim cohort, representing 72% all of patients treated, demonstrates a promising target lesion revascularization rate through 6-month follow-up of 10.8%. As previously reported, the primary efficacy endpoint of residual stenosis ≤ 50% following Pantheris treatment alone was achieved in 96.3% (158/164) of lesions, significantly outperforming the predefined study goal of 87%.

In Avinger’s press release, Dr. Schwindt commented, “I have been impressed with the Pantheris technology, especially the amount of additional information and precision available during the intervention. The high efficacy and low target lesion revascularization results through 6 months further confirm my belief that the precision offered through real-time optical coherence tomography visualization at the point of therapy will have a lasting effect on patient outcomes. This new tool will make atherectomy a safer and more effective procedure for patients with peripheral artery disease.”

The company noted that additional metrics from the VISION trial support Pantheris as a standalone therapeutic capability with 55% of lesions being treated with Pantheris alone. Placement of a stent after treatment with Pantheris was only 4% across all lesions treated (n = 7). On average, following treatment using Pantheris with or without adjunctive therapy, arterial stenosis was reduced from 78.7 ± 15.2% pretreatment to 22.2 ± 9.8% posttreatment, which represents a 70.5% reduction in stenosis. These results correlate with statistically significant improvements in both ankle-brachial index and Rutherford classification at 6 months.

In addition, the company states that histologic analysis of the VISION trial atherectomy specimens highlights the precision that real-time optical coherence tomography guidance enables during directional atherectomy. Across all lesions treated, the average percent area of adventitia in tissue removed was 1%. The company stated that this result confirms that real-time imaging provides the feedback necessary for physicians to treat peripheral artery disease without damaging normal arterial structures such as adventitia, which has been shown to potentiate restenosis. Histologic results are expected to be a key differentiator in the VISION trial. These findings will be used to further support the Avinger hypothesis that minimizing arterial wall disruption during therapy promotes reduced adjunctive treatments and improved long-term arterial patency, and ultimately minimizes the need for reintervention.