Trial of a Novel Paclitaxel-coated Balloon With Citrate Excipient for Restenosis in -Limus Analogue Drug-eluting Coronary Stents

The optimal management of patients presenting with drug-eluting stent (DES) restenosis remains unclear. Data from recent randomized clinical trials have suggested that angioplasty with drug-coated balloons (DCB) is associated with excellent clinical outcomes. However, as the effectiveness of DCB devices depends critically on the specific composition of its matrix coating there may be important differences in clinical performance between different DCB devices. The prospective, non-randomized, single arm, historical-control ISAR-DESIRE 3A trial is designed to test that hypothesis that angioplasty with a novel paclitaxel-coated balloon with citrate-based excipient (Agent PCB, Boston Scientific) will be non-inferior to a conventional paclitaxel-coated balloon with iopromide excipient (SeQuent Please PCB, B. Braun; data from ISAR-DESIRE 3) for the treatment of coronary restenosis after implantation of limus-analogue drug-eluting stents (DES). The key inclusion criteria are patients with symptoms and/or objective signs of ischemia, restenosis at the site of previous limus-analogue DES implantation and written, informed consent. The primary endpoint is in-segment percent diameter stenosis (%DS) at 6-8 month follow-up angiography. Sample size calculation is based on a non-inferiority analysis: %DS of 35% after Both PCB, non-inferiority margin of 7% absolute, 1-sided α-level of 0.05 and power of 80% resulting in 102 patients per group. To account for possible FU losses 125 patients in total will be enrolled.