Trials / Recruiting
RecruitingNCT06959524
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
AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,616 (estimated)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The study will also contain a PK sub study and an IVUS sub study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Drug Eluting Balloon | AGENT DCB |
| DEVICE | Drug eluting stent | Any commercially available DES used for standard of care. |
| PROCEDURE | Plain old balloon angioplasty | Bifurcation side branch - POBA |
Timeline
- Start date
- 2025-08-21
- Primary completion
- 2028-03-01
- Completion
- 2032-03-01
- First posted
- 2025-05-06
- Last updated
- 2026-04-17
Locations
46 sites across 6 countries: United States, Australia, Germany, Ireland, New Zealand, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06959524. Inclusion in this directory is not an endorsement.