ESSENTIAL ISR Study

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)

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