Boston Scientific ((BSX)) announced an update on their ongoing clinical study.
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Boston Scientific is currently recruiting for its clinical study titled AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease. The study aims to evaluate the safety and effectiveness of the AGENT Drug-Coated Balloon (DCB) compared to the standard percutaneous coronary intervention (PCI) treatment using drug-eluting stents (DES) and/or balloon angioplasty for patients with de novo coronary lesions. This study is significant as it explores alternative treatment strategies that could potentially reduce the need for stent implantation.
The intervention being tested is the AGENT Drug-Coated Balloon, a device designed to treat coronary artery disease by delivering medication directly to the arterial wall, potentially avoiding the need for stent placement.
The study is designed as a prospective, multicenter, open-label, randomized controlled trial with a 1:1 allocation. It uses a parallel intervention model and is primarily focused on treatment. The study does not involve masking, although independent outcome assessors will be masked where possible.
The study began on April 28, 2025, with the latest update submitted on October 17, 2025. These dates are crucial as they indicate the study’s progress and the timeline for potential results that could impact clinical practices and market dynamics.
The outcome of this study could significantly influence Boston Scientific’s market position, particularly if the AGENT DCB proves to be a viable alternative to current PCI treatments. Positive results may boost investor confidence and stock performance, while also impacting competitors in the coronary intervention market.
The study is ongoing, with further details available on the ClinicalTrials portal.