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August, 2026

Launch of international BASKET BALL trial to evaluate a drug-coated balloon-only strategy for complex coronary interventions

We're pleased to announce the enrollment of the first patient in the BASKET BALL trial (NCT07363161).

BASKET BALL is 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 BASKET BALL trial is based on the hypothesis that a sirolimus drug-coated balloon (DCB)-only approach is non-inferior to a primary drug-eluting stent (DES) strategy, with regard 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 across 15 countries in up to 60 clinical sites. The study is led by Prof. Raban Jeger (Zurich, Switzerland) and Prof. Bruno Scheller (Homburg/Saar, Germany).

Reached a milestone with the enrollment of the first patient: Prof. Raban Jeger (front) with his team and B. Braun employees.

“BASKET BALL addresses an important clinical question in patients with complex coronary artery disease. The trial will provide valuable evidence on the role of a sirolimus-coated balloon-based treatment strategy in this high-risk population.”

Prof. Raban Jeger, Zurich, Switzerland

“This landmark trial is designed to generate robust evidence on the use of drug-coated balloons in complex coronary interventions. 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.”

Prof. Bruno Scheller, Homburg/Saar, Germany

DCB confidence starts with evidence.

As a pioneer in DCB technology, B. Braun has generated one of the most comprehensive evidence bases in DCB-PCI, with more than 145 clinical studies and publications across the SeQuent® DCB portfolio. Much of this evidence has been generated with SeQuent® Please/NEO, currently the most extensively studied coronary DCB worldwide.¹

Building on this foundation, the sirolimus-coated SeQuent® SCB has demonstrated non-inferiority to SeQuent® Please/NEO in five randomised clinical trials. Further strengthening the clinical evidence base, the recently presented one-year SCORE results and the launch of the BASKET BALL trial mark important milestones in supporting the use of DCB treatment for patients with coronary artery disease.

Find out more

Get in touch with our Interventional Vascular Therapy team.

References

1. B. Braun. PubMed literature search on clinical coronary trials involving paclitaxel-coated balloons (PCBs): numbers of trials, enrolled patients and countries of conduct. Data on file. Conducted February-March 2022.