SELUTION DeNovo Trial Demonstrates Non-Inferiority of Drug-Eluting Balloon to Standard-of-Care for In-Stent Restenosis: Late-Breaking Results from TCT 2025

SELUTION DeNovo Trial Results

The SELUTION DeNovo randomized clinical trial,! presented at TCT 2025 in San Francisco, USA, demonstrates non-inferiority of the SELUTION SLR sirolimus-eluting balloon to standard-of-care for in-stent restenosis.

A percutaneous coronary intervention (PCI) strategy using the SELUTION SLR sirolimus-eluting balloon with provisional stenting was found to be non-inferior to the systematic use of drug-eluting stents (DES) for the treatment of de novo coronary lesions at one year.

The trial was designed to test whether a stent-minimizing approach could achieve outcomes comparable to standard DES implantation.

Author's summary: SELUTION DeNovo trial shows non-inferiority of drug-eluting balloon.

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Medical Dialogues Medical Dialogues — 2025-10-28

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