iVascular announces the successful completion of patient recruitment for the angioDAPT trial, enrolling a total of 2,312 patients across 38 sites in Spain, Belgium, and France.
The angioDAPT trial is a 2×2 factorial, all-comer, multicenter, randomized controlled trial, conducted to evaluate ischemic and bleeding outcomes after implantation of the iVascular Angiolite drug-eluting stent and an abbreviated dual antiplatelet therapy.
Patients with coronary artery disease were first randomized into two groups based on the device (Angiolite vs. Xience) and subsequently into two groups according to the antiplatelet treatment strategy (abbreviated DAPT vs. Standard of care DAPT).
As stated by the Lead Global Scientific Coordinator Dr. Sabaté (H. Clínic Barcelona), “The main purpose of the angioDAPT trial is to assess the safety and efficacy of the Angiolite stent compared to Xience stent family and demonstrate that an abbreviated DAPT may reduce bleeding events compared to a standard of care regimen without increasing the risk of ischemic events. Completing recruitment in such a large-scale trial brings us closer to answering questions for daily clinical practice”.
The study includes two co-primary endpoints: target lesion failure at 1 year (non-inferiority test between Angiolite and Xience) and clinically relevant bleeding at 1 year (superiority test for abbreviated DAPT vs. standard DAPT). A key secondary endpoint will assess ischemic events between both antiplatelet strategies (tested for non-inferiority).
Dr. Dewilde (Lead National Scientific Coordinator for Belgium) added: “The all-comers nature of the angioDAPT trial and the inclusion of patients at increased bleeding risk make its results highly relevant for real-world practice. Together with our colleagues in Spain and France, we have contributed a large number of patients aligned with the main objectives of the study. As angioDAPT moves into its next phases, the same level of commitment and scientific rigor will be essential to determine whether abbreviated DAPT strategies can safely reduce bleeding without compromising ischemic protection.”

The Angiolite stent has extensive real-world clinical data. Angiolite combines drug-eluting technology with an optimized strut design, delivering proven efficacy and safety in real-world settings. Its design supports early endothelialization, which is essential for enabling shorter DAPT regimens without compromising protection against thrombotic events.
Dr. Garot (Lead National Scientific Coordinator for France), commented: “Angiolite is a drug-eluting stent with a strong scientific rationale and extensive real-world clinical experience. angioDAPT provides a unique opportunity to keep rigorously evaluating its performance against a reference stent within a large, randomized, all-comers population, while simultaneously addressing the important question of antiplatelet therapy duration.”
iVascular thanks all investigators, participant sites and study teams for their highly valuable efforts and strong commitment in generating real-world evidence to support clinical decision-making, particularly in complex and high-risk patients.

