Preliminary Results Presented for AngioScore's AngioSculpt Drug-Coated Scoring Balloon Catheter

November 12, 2013—AngioScore, Inc. (Fremont, CA) announced detailed preliminary clinical trial results from the PATENT-C first-in-human study of the company's drug-coated AngioSculpt scoring balloon catheter. The company announced completion of enrollment in the trial in June.

The 6-month clinical and quantitative coronary angiography results from PATENT-C were first presented during the week of October 28 at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California.

According to AngioScore, the PATENT-C trial enrolled 61 patients with coronary in-stent restenosis at four sites in Germany and one site in Brazil. The study was led by Bruno Scheller, MD, Professor of Interventional Cardiology at Saarland University Hospital in Homburg, Germany.

The company stated that the PATENT-C study was designed as a randomized controlled trial comparing the investigational drug-coated AngioSculpt with the commercially available uncoated version of the AngioSculpt in patients presenting with significant restenosis in a previously implanted coronary bare-metal stent. Patients underwent follow-up quantitative coronary angiography at 6 months to compare the rate of recurrent restenosis and late lumen loss (LLL) in both treatment arms. Additional study endpoints included the rate of major adverse cardiovascular events, clinically driven target lesion revascularization, and stent thrombosis for up to 2 years following the index procedure. All angiograms were analyzed by an independent core laboratory at the Cardiovascular Research Foundation in New York, New York.

AngioScore reported that the trial met its primary efficacy endpoint, with an in-segment LLL of 0.14 ± 0.4 mm and 0.47 ± 0.51 mm for the drug-coated and uncoated AngioSculpt groups, respectively (P < .05). The company noted that this was even more significant when the patients were evaluated according to the actual treatment received, with the drug-coated AngioSculpt group achieving a remarkable in-segment LLL of 0.07 ± 0.24 mm (P < .01). These angiographic findings were paralleled by a marked reduction in adverse events, including clinically driven target lesion revascularization, in the drug-coated AngioSculpt treated patients.

The drug-coated AngioSculpt scoring balloon catheter is an investigational device that is limited by applicable law to investigational use and is not available for sale, advised the company.