At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Performance of the XLIMUS Sirolimus-eluting Coronary Stent In Very Complex Lesions
In Brief
A Phase 4 clinical trial evaluating XLimus for Coronary Atherosclerosis Due to Calcified Coronary Lesion and Chronic Total Occlusion of Coronary Artery. Completed, enrolled 200 participants across 1 site.
Detailed Summary
Stent delivery failure occurs in 4% of all percutaneous coronary interventions (PCI) and \>90% of these failures are due to vessel tortuosity and/or calcification. The XLIMUS eluting coronary stent (CARDIONOVUM GmbH, Bonn, Germany) is a new type of endovascular prostheses characterised by better mechanical properties than traditional DES. This is a prospective, non-randomized, single-center pilot study, aiming to evaluate the performance of the XLIMUS DES in severely complex coronary lesions in real-world clinical practice.
Study Details
Timeline
Interventions
Techniques attempted for facilitating stent delivery in such a complex lesions are: maximize guide catheter support, optimize predilatation of the stenosis, use of a stiffer guidewire. Specific tricks include: a) buddy-wire; anchoring balloon; GuideLiner catheter. In case of severe calcification, rotational atherectomy was electively performed with the Rotablator® system (Boston Scientific Corporation, Natick, MA, U.S.A.). Following stent implantation, postdilatation is performed in all instances with a non-compliant balloon