A real-world study investigating the luminor drug-coated balloon (DCB; iVascular) in Brazil has started, following approval for commercialisation of the device by ANVISA, the Brazilian regulatory authority. LUMBRA (LUMinor balloon in a BRAzilian registry for real-world lesions) aims to corroborate the efficacy and safety results of luminor in Europe demonstrated by the EFFPAC and TINTIN trials.
The LUMBRA trial has the objective of evaluating the long-term outcomes of treatment with the luminor DCB, followed by potential bail-out stenting with the iVolution stent (iVascular) in symptomatic femoropopliteal arterial stenotic or occlusive lesions in 200 patients from Brazil. The first patient to be enrolled was included on 30 November 2019.
The primary endpoint of the registry is primary patency at 12 months. The secondary endpoints include: technical success, procedural success, primary patency rate freedom from target lesion revascularisation, changes in ankle-brachial index measurements, and serious adverse events, as defined per ISO 14155:2011.
Pierre Galvagni (Federal University of Santa Catarina, Florianopolis, Brazil), principal investigator of the trial states: “We were expecting to have luminor in Brazil; this trial will allow us to corroborate in [a] real-world Brazilian population the great outcomes of luminor DCB”.