US-based AngioScore has announced detailed preliminary clinical trial results from the first-in-human (FIH) study (PATENT-C) of the drug-coated AngioSculpt scoring balloon catheter.
The catheter's innovative nitinol elements offer circumferential scoring of plaque, resulting in precise and predictable luminal enlargement across a wide range of lesion types.
It is reportedly the first drug-coated scoring balloon catheter available on the market.
The aim of PATENT-C study was to compare the drug-coated AngioSculpt with the commercially available uncoated version in patients showing considerable restenosis in a previously implanted coronary bare metal stent.
This FIH randomised controlled trial enrolled 61 patients with coronary in-stent restenosis (ISR) at four sites in Germany and one in Brazil.
Patients were routinely followed clinically and with serial quantitative coronary angiography (QCA) at six months to compare the rate of recurrent restenosis and late lumen loss (LLL) in both treatment arms.
The drug-coated scoring balloon trial endpoints also include the rate of major adverse cardiovascular events (MACE), clinically driven target lesion revascularisation (TLR) and stent thrombosis for up to two years following the index procedure.
The six-month clinical and QCA results from PATENT-C were first presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco during the week of 28 October.
Overall, the trial easily met the primary efficacy endpoint with an in-segment LLL of 0.14±0.4mm and 0.47±0.51mm for both drug-coated and uncoated AngioSculpt groups respectively (p<0.05).
The drug-coated AngioSculpt group attained a remarkable in-segment LLL of 0.07±0.24 mm (p<0.01), when the patients were evaluated according to the actual treatment received.
These angiographic findings were paralleled by a marked reduction in adverse events, including clinically driven TLR, in the drug-coated AngioSculpt treated patients.
AngioScore co-founder and chief medical officer Dr Gary Gershony said the six-month results of the PATENT-C Trial are among the best angiographic and clinical outcomes available to-date for the emerging field of drug-coated balloons.
"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," Dr Gershony said.
AngioSculpt catheters have been used in more than 300,000 procedures worldwide to date and have an established safety and performance record in the treatment of both coronary and peripheral artery disease.
The drug-coated AngioSculpt scoring balloon catheter is a prototype device and is currently not available for sale in the US.