November 14, 2013 — AngioScore, Inc., a developer of angioplasty catheters for use in the treatment of cardiovascular disease, announced detailed preliminary clinical trial results for the world’s first drug-coated scoring balloon catheter.
This first-in-human (FIH) trial of a novel drug-coated AngioSculpt PTCA (percutaneous transluminal coronary angioplasty) Scoring Balloon Catheter (PATENT-C) enrolled 61 patients with coronary in-stent restenosis (ISR) at five sites: four in Germany and one in Brazil. Bruno Scheller, M.D., professor of interventional cardiology, Saarland University Hospital, Homburg, Germany led the study.
The PATENT-C study was designed as a randomized controlled trial comparing the recently developed 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 (QCA) at six 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 (MACE), clinically driven target lesion revascularization (TLR) and stent thrombosis for up to two years following the index procedure. An independent core laboratory at the Cardiovascular Research Foundation in New York analyzed all angiograms.
The six-month clinical and QCA results from PATENT-C were first presented at the Transcatheter Cardiovascular Therapeutics Conference (TCT 2013) in San Francisco. Overall, the trial easily met the 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<0.05). This was even more significant when the patients were evaluated according to the actual treatment received, with the drug-coated AngioSculpt group achieving an in-segment LLL of 0.07±0.24 mm (p < 0.01). These angiographic findings were paralleled by a marked reduction in adverse events, including clinically driven TLR, in the AngioSculpt-treated patients.
“The six-month results of the PATENT-C Trial are impressive and appear to be among the best angiographic and clinical outcomes available to date for the emerging field of drug-coated balloons,” said Gary Gershony, M.D., co-founder and chief medical officer, AngioScore. “The development of a drug-coated AngioSculpt Scoring Balloon Catheter has the potential to become a disruptive new technology for the treatment of complex coronary and peripheral artery disease.”
AngioSculpt catheters have now been used in more than 300,000 procedures worldwide.
The Drug-Coated AngioSculpt Scoring Balloon Catheter is an investigational device, limited by applicable law to investigational use and not available for sale.
For more information: www.angioscore.com