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
← catalyst calendarNCT06959524 · readout ≤ 590 d
Sponsored by Boston Scientific Corporation (industry) · BSX — their whole pipeline →.
Phase
Not applicable
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,616estimated
Sites
67
Countries
Australia, China, Germany +6
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-08-21 | actual | When the study began enrolling |
| Primary completion | Mar 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2025-05-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Coronary Arterial Disease (CAD)
- de Novo Lesions in Native Coronary Arteries
Interventions
- Device: Drug Eluting Balloon — also filed as DCB
- Device: Drug eluting stent — also filed as DES
- Procedure: Plain old balloon angioplasty
Primary outcome
what the primary-completion date above is the date OFTarget Lesion Failure (TLF) rate
measured 12-Month
Permalink · BSX's whole pipeline · Catalyst calendar · Every registered study · What changed