Background: The aim of MERLION (NCT04073121) was to evaluate the outcomes of the mono or combination therapy of the iVascular Luminor™ drug-coated balloon (DCB) and Angiolite™ drug-eluting stent for treatment of TASC II C/D tibial occlusive lesions in Asian patients presenting with chronic limb threatening ischemia (CLTI) from Singapore.
Methods: MERLION was a prospective, non-randomized, single arm, observational, multicenter clinical study. Complication-free survival at one month was the safety endpoint.