Angiographic and optical coherence tomography assessment of the new drug-eluting balloon ESSENTIAL for the treatment of In-Stent Restenosis. Published in Cardiovascular Revascularization Medicine on July 2019.
DESCRIPTION
Device
Essential
Number of patients
33
Follow up
24-month
Type of lesions
DES and BMS in-stent restenosis
OUTCOMES
Primary outcomes
In-segment maximal area stenosis at 6 months
Secundary outcomes
0.25 mm
In-segment Late Lumen Loss at 6 months
13.3 %
TLF at 24 months
13.3 %
TLR at 24 months
De La Torre Cardiovasc Revasc Med. 2019 Jul 23. pii: S1553-8389(19)30433-6
CONCLUSIONS
“Clinical efficacy seems to be good and maintained on the very long term.”
In this study, the drug-coated balloon Essential showed a good efficacy in the treatment of ISR (mostly of DES) in terms of OCT and QCA assessment, which appear to be comparable to the provided by other drug-coated balloons well supported by clinical evidence.
Published in Cardiovascular Revascularization Medicine on July 2019.
The publication of ESSENTIAL ISR Trial is available here.
MAIN INVESTIGATOR
José M. de la Torre Hernandez
Universitary Hospital Marqués de Valdecilla, (Santander, SPA)
