DEB or DES for the treatment of calcified nodules after intravascular lithotripsy: the DEBSCAN-IVL trial design.

Introduction and objectives: Calcified coronary nodules (CN) are among the most challenging lesions for percutaneous coronary intervention, as drug-eluting stents (DES) frequently result in suboptimal expansion, malapposition, and recurrent adverse events. Although intravascular lithotripsy (IVL) provides effective plaque modification, the optimal definitive strategy remains unclear. Drug-eluting balloons (DEB) have demonstrated potential in the treatment of complex lesions in which stent implantation may be less desirable. This trial aims to compare the safety and efficacy profile of DEB vs DES after IVL in patients with CN. Methods: We conducted a retrospective, investigator-initiated, multicenter, non-inferiority, randomized clinical trial. Results: A total of 128 patients with de novo CN confirmed by intracoronary imaging in vessels measuring 2.5 mm to 4.0 mm in diameter will be enrolled across 10 high-volume percutaneous coronary intervention centers. After lesion preparation with IVL, patients will be randomized on a 1:1 ratio to receive a DEB or a DES. The co-primary endpoints are late lumen loss and net luminal gain at 9 ± 1 months of angiographic follow-up, both assessed by an independent core laboratory. Secondary endpoints include procedural, angiographic, and clinical outcomes, adjudicated by a blinded clinical events committee. Clinical follow-up will be conducted at 1 month, 1 year, and 2 years. Conclusions: The DEBSCAN-IVL trial will provide the first randomized evidence comparing DEB and DES after IVL for CN.Registered at ClinicalTrials.gov: NCT06657833.