AngioScore, a developer of angioplasty catheters, has commenced patient enrolment in its drug-coated AngioSculpt scoring balloon catheter first-in-human (FIH) study.
The AngioSculpt scoring balloon catheters are innovative nitinol elements that offer unique circumferential scoring of plaque, resulting in precise and predictable luminal enlargement across a range of lesion types.
The randomised, controlled FIH trial of the drug-coated scoring balloon will enroll 60 patients with coronary in-stent restenosis (ISR) in Germany and Brazil.
The drug-coated AngioSculpt FIH study is intended 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.
In the study, patients will undergo follow-up coronary angiography at six months in order to compare the rate of recurrent restenosis and late lumen loss (LLL) in both treatment arms.
The drug-coated scoring balloon trial endpoints 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.
Study leader and Germany Interventional Cardiology professor Bruno Scheller from Saarland University Hospital, Homburg, said the development of a drug-coated AngioSculpt could represent an advancement in the percutaneous treatment of endovascular disease.
"I am honoured to lead this important study and to collaborate with such an internationally prominent interventional cardiologist as Professor Alexandre Abizaid and his team at Dante Pazzanese Institute of Cardiology in Sao Paulo, Brazil," Scheller added.
AngioScore co-founder and chief medical officer Gary Gershony said pre-clinical studies have demonstrated the safety of the drug-coated AngioSculpt and its ability to have a profound effect on inhibiting restenosis.
"The AngioSculpt scoring balloon catheter represents a significant improvement over conventional angioplasty balloon catheters for the treatment of challenging coronary and peripheral lesions due to its ability to achieve more predictable luminal expansion, avoid slippage or geographic miss, and result in a lower rate of dissection,'' Gershony said.
The drug-coated AngioSculpt may provide a shortened course of dual anti-platelet therapy and have the ability to transform the treatment of many patients with challenging lesions.