Clinical Trial

AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions

Recruiting
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Summary
AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention (PCI) treatment with drug eluting stent (DES) and/or balloon angioplasty in patients with de novo coronary lesions. Subjects must have a de novo target lesion located in a native coronary artery.
Protocol Amendment History 5 changes
notable Trial sites expanded: 62 -> 67 locations 2026-07-31
notable Trial sites expanded: 55 -> 62 locations 2026-07-03
notable Trial sites expanded: 50 -> 55 locations 2026-06-04
notable Trial sites expanded: 46 -> 50 locations 2026-05-08
notable Trial sites expanded: 41 -> 46 locations 2026-04-18
Trial Details
NCT Number NCT06959524
Lead Sponsor Boston Scientific Corporation
Conditions Coronary Arterial Disease (CAD), de Novo Lesions in Native Coronary Arteries
Enrollment 1,616 participants
Start Date 2025-08-21
Primary Completion 2028-03 (estimated)
Study Completion 2032-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-30