CARDIONOVUM announces completion of patients enrolment in XLIMIT Trial

Trial designed to evaluate non inferiority of XLIMUS DES vs SYNERGY EES in terms of reendothelialization assessed with OCT in patients undergoing percutaneous coronary intervention

Bonn, Germany. CARDIONOVUM announced today that patients enrolment for XLIMIT Trial has been completed.

XLIMIT, a randomized, controlled superiority study, is the first trial intended to compare angiographic performance of XLIMUS drug-eluting stent (DES) versus SYNERGY (EES), in patients with documented coronary artery disease and indication for percutaneous coronary intervention for stable or unstable angina or non ST elevated myocardial infarction.

XLIMUS DES is characterized by very low strut thickness, which provides greater conformability and deliverability and it is responsible of less shear disturbances, leading to improved reendothelialization. Patients enrolled in the study will undergo a control coronary angiography with Optical Coherence Tomography (OCT) to assess endothelization at 6 months follow up and followed up to 12 months for clinical outcomes.

The international multicentre XLIMIT trial has currently enrolled 180 patients in 4 study centres across Italy and Spain: enrolled patients have been randomized to receive either XLIMUS DES or SYNERGY EES.

XLIMIT’s primary endpoint is the reendothelialization grade of the XLIMUS stent in terms of struts coverage and neointimal hyperplasia volume as compared to the Synergy stent at 6 months. More details of the trial design were published in IJC Heart and Vasculature at the end of 2019¹.

“The XLIMIT trial will provide insights into the endothelialization process of the XLIMUS DES sirolimus eluting stent compared to the SYNERGY everolimus eluting stent and assess clinical results in terms of cardiovascular clinical outcomes after 1 year.” commented Principal Investigator Dr.Luca Testa (Policlinico S.Donato, Milano, Italy).

From left to right: Dr. Antonio Popolo Rubbio, Dr. Nedy Brambilla, Dr. Luca Testa,
Dr. Francesco Bedogni, Dr. Mattia Squillace

ABOUT CARDIONOVUM GMBH

CARDIONOVUM GmbH is a medical technology company based in Bonn, Germany, that develops and commercializes innovative medical devices such as the new generation of drug coated balloons and drug eluting stents for the treatment of coronary and peripheral artery disease. The company’s pioneering range of DCBs is based on the SAFEPAX® paclitaxel coating matrix which has the lowest wash-off rates on the market. The company’s clinical program ensures the continuous growth of the clinical evidence that supports the benefits of our products.

1:Testa L, Pero G, Bollati M, Casenghi M, Popolo Rubbio A, Cuman M, Moreno R, Serra A, Gomez JA, Bedogni F. XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial. Int J Cardiol Heart Vasc. 2019 Apr 28;23:100363. doi: 10.1016/j.ijcha.2019.100363. PMID: 31061876; PMCID: PMC6487315.