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 now · Not applicable

Conditions studied: Coronary Arterial Disease (CAD), de Novo Lesions in Native Coronary Arteries

In brief

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.

Key facts

Study ID

NCT06959524

Run by

Boston Scientific Corporation

People needed

1616

Starts

2025-08-21

Expected to finish

2032-03-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• USC Medical Center — Los Angeles, California, United States (enrolling)
• Cedars - Sinai Medical Center — Los Angeles, California, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• Stanford University Medical Center — Stanford, California, United States (enrolling)
• Los Robles Hospital & Medical Center — Thousand Oaks, California, United States (enrolling)
• South Denver Cardiology Associates, PC — Littleton, Colorado, United States (enrolling)
• The Cardiac and Vascular Institute Research Foundation — Gainesville, Florida, United States (enrolling)
• Mount Sinai Medical Center — Miami Beach, Florida, United States (enrolling)
• Piedmont Hospital — Atlanta, Georgia, United States (enrolling)
• Emory University Hospital — Atlanta, Georgia, United States (enrolling)
• Wellstar Kennestone Hospital — Marietta, Georgia, United States (enrolling)
• Northwestern University — Evanston, Illinois, United States (enrolling)
• Endeavor Health — Glenview, Illinois, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• University of Michigan Hospitals — Ann Arbor, Michigan, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• Corewell Health — Grand Rapids, Michigan, United States (enrolling)
• Mercy Hospital — Coon Rapids, Minnesota, United States (enrolling)
• St. Luke's Hospital of Kansas City — Kansas City, Missouri, United States (enrolling)
• NYU Langone Hospital — Brooklyn, New York, United States (enrolling)
• Mount Sinai Medical Center — New York, New York, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Scripps Memorial Hospital — La Jolla, California, United States (enrolling)

Full record on ClinicalTrials.gov

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