Barcelona, 3rd of December,2019. After the luminor DCB approval for commercialization by ANVISA, the Brazilian regulatory authority, the real-world study LUMBRA has started. The the aim of LUMBRA is corroborating the efficacy and safety results of luminor in Europe demonstrated on the EFFPAC and TINTIN trials.
LUMBRA, LUMinor balloon in a BRAzilian registry for real world lesions, has the objective of evaluating the long-term outcomes of treatment with luminor, followed by potential bail-out stenting with the iVolution stent in symptomatic femoropopliteal arterial stenotic or occlusive lesions in 200 patients from Brazil. The first patient has been included on November 30th, 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 TLR, changes in ABI measurements and serious adverse events as defined per ISO 14155:2011.
Prof Pierre Galvagni (Florianopolis, Brazil), principal investigator of the trial stated that
“We were expecting to have luminor in Brazil, this trial will allow us to corroborate in real world Brazilian population the great outcomes of luminor DCB”.