ABSTRACT
Current techniques employing cylindrical and dedicated bifurcation stentsystems are limited. The ABS Modular Bifurcation System is a novel platformdesigned for automatic orientation and alignment of main branch and side branchstents with complete coverage of carina and side-branch access in a simpleintuitive procedure. This first-in-human implant study aims to provide preliminaryevidence of feasibility and short-term efficacy.Methods and results: Patients with de novo bifurcation lesions were enrolled inthis pilot, non-randomised, multi-center trial evaluating the safety, technicalfeasibility, and acute efficacy of the ABS Platform. Preliminarily results areavailable for 10 patients to date. The ABS full bifurcation stenting system (MD-BI)was deployed in the following bifurcations (7 so far): LAD- Diag (n=2), LCx-OM(n=3), and PDA-PLB (n=2) (Fig. 3). The provisional system (MD-P) has beendeployed in 3 patients so far. All lesions were Medina 1, 1, 1. Average patient agewas 55. Delivery rate and procedural success was 100%, and there was noresidual stenosis by IVUS, which revealed good stent apposition with completecoverage of the vessel carina. The 30-day composite MACE (death, MI, andtarget vessel revascularisation) was 0%. 6 month composite MACE as well asTVR has remained 0%. All patients are free of angina. Aniographic follow-up todate has been completed in 4 patients and has revealed edge re-stenosis in 2side-branch vessels only. The carina has remained widely patent with no evidenceof re-stenosis.Conclusions: The ABS Bifurcation Stent Delivery System is a novel stentplatform designed to reproducibly permit stenting in bifurcation lesions regardlessof branch angulation in a short, simple and intuitive procedure. This first-in-humanimplant study provides preliminary evidence of feasibility and short-term efficacy.