Concept Medical Announces First Patient Enrolled in STARS DAPT Trial Evaluating Abluminus NP, a Polymer-Free Drug-Eluting Coronary Stent for Shortened Antiplatelet Therapy

Concept MedicalAnnouncing itsPolymer-free Drug-eluting Coronary Stent---Abluminus NPCompletedSTARS DAPT Clinical TrialThe first patient enrolled.

STARS DAPT is an investigator-initiated, prospective, multicenter, international, open-label randomized controlled pilot study. The trial plans to enroll 350 patients receivingAbluminus NPSTEMI patients treated with primary PCI were aimed to compare the differences between P2Y12 receptor inhibitor monotherapy after short-term dual antiplatelet therapy and conventional 6 or 12 months of dual antiplatelet therapy. The dual primary endpoints at 12 months included major adverse cardio-cerebral events and major bleeding complications.

PI Evaluation

"Acute STEMI patients present unique therapeutic challenges, characterized by a dual-risk profile: a high thrombotic and inflammatory state leading to an elevated risk of ischemic events, while intensified antithrombotic therapy increases the risk of bleeding. Striking a balance between preventing acute thrombotic events and reducing major bleeding remains a significant challenge in clinical practice. Advances in polymer-free drug-eluting stent technology offer the potential for novel antiplatelet strategies post-PCI, aiming to maintain ischemic protection while reducing bleeding risk. STARS DAPT is the first randomized trial to evaluate the non-inferiority of a P2Y12 inhibitor monotherapy regimen following an ultra-short course of dual antiplatelet therapy, which will compare...Abluminus NPPrimary ischemic and bleeding outcomes at 12 months post-implantation. The results are expected to provide crucial evidence for antiplatelet therapy regimens after primary PCI, potentially significantly improving the current treatment landscape for STEMI.

---Juan F. Iglesias  Geneva University Hospitals

Executive Evaluation

"STARS DAPT Trial InitiatedThe inclusion criteria areAbluminus NPDevelopment FocusTo achieve milestones. Although modern drug-eluting stents have achieved good results, challenges remain, such as polymer-related inflammation, late catch-up phenomena, and the long-term need for dual antiplatelet therapy.Abluminus NPAs a polymer-free submicron sirolimus delivery platform, it achieves more uniform drug distribution, covering stent struts, edges, and adjacent vascular segments. This trial will verify whether this technology can safely and effectively shorten the duration of dual therapy, especially for patients at high risk of bleeding.

---Manish Doshi  Founder and Managing Director of Concept Medical Group

Abluminus NP

Abluminus NPYesNew Generation WithoutPolymer Drug-Eluting Stent,Designed with a thin-walled stent, throughNanoActiveTechnology, promote natural arterial healing, accelerate vascular re-endothelialization, and alleviate chronicSex-related inflammatory response, with the potential to reduce the duration of dual antiplatelet therapy.

Abluminus NP Core TechnologySurgery (NanoActive）

NanoActive is a next-generation cardiovascular drug delivery platform that combines precise submicron engineering technology with established sirolimus therapy to optimize drug efficacy.NanoActiveUtilizing submicron drug carriers to enhance drug permeability and uniform distribution within the vascular wall

NanoActive utilizes the principle of volume-to-surface-area ratio to ensure maximum coverage, allowing drugs to penetrate deep into tissues up to the outer membrane, thereby achieving effective intratissue drug release. This controlled local drug delivery method minimizes systemic exposure while maximizing therapeutic efficacy.

Advantages of Abluminus NP

• Better positioning and delivery rate

• Advanced Balloon Design for Complex Lesions

• Uniform Coverage: Extraluminal Stent Coating + Balloon Shoulder to Prevent Edge Restenosis.

• Safety and Durability: Transition to a BMS-like structure within months, minimizing late events.