Clinical Feasibility of Novel Paclitaxel-Coated Balloon with Shellac plus Vitamin E Excipient in Patients with De Novo Coronary Artery Lesion

Background Drug-coated balloons (DCBs) are increasingly used for de novo coronary lesions (DNCLs), particularly in small vessels. The GENOSS DCB is a novel paclitaxel-coated balloon using a shellac plus vitamin E excipient, previously effective in in-stent restenosis, but its feasibility in DNCLs remains unclear. This study evaluated the clinical feasibility of GENOSS DCBs in DNCLs. Methods This was a prospective, multicenter, single-arm pilot study of patients with DNCLs (2.0–4.0 mm in diameter). The primary endpoint was in-segment late lumen loss (LLL) at 6 months. Secondary endpoints included device/procedure success rate, restenosis rate, cardiac death, myocardial infarction, stent thrombosis, and target lesion revascularization (TLR) at 6-month follow-up. Results A total of 20 patients (mean age 66.0 ± 10.3 years; 70% male) were enrolled from two academic centers. Device and procedure success was achieved in all patients. The 6-month in-segment LLL was –0.17 ± 0.3 mm, and no restenosis was observed. Diameter stenosis improved from 48.5 ± 13.8% post-DCB to 23.69 ± 9.3% at 6 months. One non-TLR was reported, with no cardiac death, myocardial infarction, stent thrombosis, or TLR. Conclusions GENOSS DCBs showed favorable angiographic and clinical outcomes at 6 months, supporting their feasibility as a treatment for DNCLs.