Concept Medical Announces First Patient Enrollment in STARS DAPT Randomized Clinical Trial Evaluating Abluminus NP Polymer-Free DES

(BUSINESS WIRE)--Concept Medical Inc., a global pioneer in innovative drug delivery technology, is proud to announce the successful enrollment of the first patients in the STARS DAPT (ST-Segment Elevation Myocardial InfArction treated with a Polymer-Free Sirolimus-based NanocarrieR Eluting Stent and a P2Y₁₂ inhibitor-based Single Antiplatelet Strategy after a Short Dual Antiplatelet Therapy versus conventional Dual AntiPlatelet Therapy) randomized controlled trial. This trial marks a significant milestone in evaluating the breakthrough technology of polymer free drug eluting stent (DES) for the treatment of STEMI patients.

The first four patients were enrolled by (Professor Barbara Stähli and her team at the University Hospital of Zurich in Switzerland initiating the much awaited RCT which will assess the different strategies to manage ACS patients with antiplatelet regimen.

STARS DAPT is an investigator-initiated, prospective, multicentre, international, open-label, randomized controlled pilot study. The trial will enrol 350 all-comer subjects with STEMI undergoing primary PCI with the Abluminus np (Concept Medical). STARS DAPT aims to study the difference between a P2Y₁₂ receptor inhibitor-based single antiplatelet therapy (SAPT) regimen after a short period of dual antiplatelet therapy (DAPT) versus conventional 6 or 12 months of DAPT. The co-primary endpoints at 12 months are major adverse cardiac and cerebrovascular events and major bleeding complications.

The RCT is led by Principal Investigator PD Dr. Juan F. Iglesias (Geneva University Hospitals and University of Geneva, Switzerland).

Newer generation polymer-free DES like the Abluminus np with thin struts, fusion and abluminal coating of Sirolimus aids in natural vascular healing of the arteries, faster re-endothelialisation and mitigating chronic inflammation which permits the possibility of potentially shortening the DAPT requirement. Abluminus np has already been studied in single-arm Indian registries with promising safety and efficacy leading up to STARS DAPT being the first randomized evaluation.

“Patients with acute STEMI represent a particularly challenging population, characterized by a dual risk profile: a high risk of ischemic events driven by a heightened prothrombotic and proinflammatory state, and an increased risk of bleeding complications associated with the use of potent antithrombotic therapies during management. Achieving an optimal balance between preventing acute thrombotic events and minimizing major bleeding remains a persistent challenge and an important unmet need in routine clinical practice. Recent advances in polymer-free DES technology may facilitate the adoption of novel antiplatelet strategies aimed at reducing bleeding risk while preserving ischemic protection after primary PCI. STARS DAPT is the first RCT designed to evaluate the non-inferiority of a P2Y₁₂ inhibitor–based SAPT strategy following a very short course of DAPT, compared with the current standard of care of 12-month DAPT, with respect to both major ischemic and bleeding outcomes at one year after primary PCI using the Abluminus np DES. The results of the STARS DAPT trial are expected to provide important insights into the optimal antiplatelet regimen after primary PCI and have the potential to meaningfully improve STEMI care,” commented PD Dr. Juan F. Iglesias on the initiation of the trial.

Dr. Manish Doshi, Founder & Managing Director of Concept Medical Group, said, “The initiation of patient enrolment in the STARS DAPT trial marks an important milestone for Abluminus np. While contemporary drug-eluting stents have achieved excellent outcomes, challenges such as polymer-related inflammation, late catch-up, and the need for prolonged dual antiplatelet therapy persist. Abluminus np was designed as a polymer-free, sub-micron sirolimus delivery platform to enable more uniform drug distribution across the diseased vessel, extending beyond the stent struts to the stent edges and adjacent vessel segments. The STARS DAPT trial is designed to evaluate whether this approach can support safe and effective reduction in DAPT duration, particularly for patients at increased bleeding risk.”

About Abluminus np

The Abluminus np DES, developed by Concept Medical Inc., utilizes proprietary Nanoactive technology to deliver polymer free sub-micron particles of sirolimus encapsulated in a biocompatible phospholipid carrier, ensuring deep penetration into the vessel wall along with faster endothelialisation. Abluminus np features polymer free fusion coating (Stent and exposed parts of balloon) with sirolimus drug coated on the abluminal surface and edges. Abluminus np has also received CE mark approval in Europe.

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