Concept Medical Begins First Patient Trial Of Abluminus NP Polymer-Free DES
Concept Medical Begins First Patient Trial Of Abluminus NP Polymer-Free DES
Concept Medical Inc. has announced the successful enrollment of the first patient in the STARS DAPT randomized clinical trial, marking a key milestone in the clinical evaluation of its polymer-free drug-eluting stent technology for patients with ST-segment elevation myocardial infarction (STEMI).
The first four patients were enrolled at the University Hospital of Zurich, Switzerland, under the leadership of Professor Barbara Stähli and her team, formally initiating the international randomized controlled trial. The study will evaluate antiplatelet treatment strategies in acute coronary syndrome patients undergoing primary percutaneous coronary intervention (PCI).
STARS DAPT is an investigator-initiated, prospective, multicentre, international, open-label randomized pilot trial that plans to enrol 350 all-comer STEMI patients treated with Concept Medical’s Abluminus np polymer-free drug-eluting stent.
The trial is designed to compare a P2Y12 inhibitor-based single antiplatelet therapy following a short course of dual antiplatelet therapy with the conventional approach of six or twelve months of dual antiplatelet therapy. The co-primary endpoints at 12 months include major adverse cardiac and cerebrovascular events and major bleeding outcomes.
The study is being led by Principal Investigator PD Dr. Juan F. Iglesias of Geneva University Hospitals and the University of Geneva, Switzerland. The trial represents the first randomized evaluation of the Abluminus np stent, following encouraging safety and efficacy data generated from earlier single-arm registries conducted in India.
Abluminus np belongs to a newer generation of polymer-free drug-eluting stents and is designed with thin struts, abluminal and fusion coating, and sub-micron sirolimus delivery. This design aims to promote faster re-endothelialisation, support natural vascular healing, and reduce chronic inflammation, potentially allowing for shorter durations of dual antiplatelet therapy, particularly in patients at higher bleeding risk.
The Abluminus np stent uses Concept Medical’s proprietary NanoActive technology, which delivers polymer-free sub-micron particles of sirolimus encapsulated in a biocompatible phospholipid carrier for deeper vessel wall penetration and uniform drug distribution beyond the stent struts. The device features drug coating on the abluminal surface, stent edges, and exposed balloon areas, and has already received CE mark approval in Europe.
The initiation of the STARS DAPT trial is expected to generate important clinical evidence on optimizing antiplatelet therapy after primary PCI and could help inform future treatment strategies for STEMI patients globally.
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