B Braun has announced the enrolment of the first patient in the BASKET BALL trial, an international, randomised, multicentre, open-label trial in patients with coronary artery disease and increased clinical or anatomical risk.
The trial is designed to create clinical evidence for a sirolimus-coated balloon—SeQuent SCB—in complex coronary artery disease. The hypothesis of BASKET BALL is that a sirolimus drug-coated balloon (DCB)-only-based approach is non-inferior to a primary drug-eluting stent (DES) strategy with respect to the composite endpoint of target vessel failure (TVF) and major bleeding (BARC types 3–5) at 12 and 36 months. A total of 2,184 patients will be enrolled at up to 60 clinical sites across up to 15 countries.
The study is led by Raban Jeger (Triemli Hosptial, Zurich, Switzerland) and Bruno Scheller (University of Saarland, Homburg/Saar, Germany).
“BASKET BALL addresses an important clinical question in patients with complex coronary artery disease,” said Jeger. “The trial will provide valuable evidence on the role of a sirolimus-coated balloon-based treatment strategy in this high-risk population.”
“This landmark trial is designed to generate robust evidence on the use of drug-coated balloons in complex coronary interventions,” added Scheller. “BASKET BALL is a strategy trial comparing a DCB-only approach including cross-over to stenting in case of unsuccessful lesion preparation compared to a 100% full-metal jacket DES strategy. Its findings may help shape the future of interventional cardiology.”
B Braun has generated a comprehensive evidence base in DCB-PCI, with more than 145 clinical studies and publications across the SeQuent DCB portfolio. Most of this evidence has been established with SeQuent Please/NEO coronary DCB.
Building on this foundation, the sirolimus-coated SeQuent SCB has demonstrated non-inferiority to SeQuent Please/NEO across five randomised clinical trials. The recently presented one-year SCORE results for SeQuent SCB and the launch of the BASKET BALL trial represent important milestones in the continued expansion of the clinical evidence base supporting DCB treatment in patients with coronary artery disease, B Braun says in a press release.
