Cardionovum® announces that the XLIMIT Trial results, featuring the XLIMUS® DES, have been published online in the Frontiers in Cardiovascular Medicine journal with the article entitled “A randomized control trial to assess optical coherence tomography parameters of the Xlimus drug-eluting stent: the XLIMIT trial”.

XLIMIT is a non-inferiority, prospective, multicenter, randomized, controlled trial in which a total of 177 patients were enrolled and randomized in two groups in a 2:1 ratio (2 XLIMUS®:1 Synergy™).

The primary endpoint of this study has been defined as the in-stent neointimal volume weighted by the sum of the lengths of implanted stent (ISNV), and the in-stent percent neointimal volume obstruction (%VO) were evaluated at 6-9 months by means of Optical Coherence Tomography (OCT).

Dott. Ielasi (Milan, Italy) speaks to Radcliffe at EuroPCR 2023 congress held in Paris (France) about the results of the Hyper Study 2-years Follow-up.

In this video interview, Dott. Ielasi summarizes the benefits of RESTORE® paclitaxel eluting balloon and comments the results of the Hyper study at 2 years, putting a focus on the encouraging results of the combined use of modern DES and RESTORE® DEB in the context of de novo diffuse CAD: in detail, results showed a 2-year clinical follow-up available for the vast majority of the patients enrolled (n=105/106, 99%) and a low incidence of Device oriented Composite Endpoint (DoCE) equal to 4.6% at 24 months.

In conclusion, even if larger and more robust data from RCTs (vs. full metal jacket PCIs) are needed to confirm the findings, the HYPER study reports very encouraging results in terms of safety and efficacy of the hybrid approach in the treatment of diffuse CAD.