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
Public ClinicalTrials.gov record NCT06959524. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06959524
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,616 participants
Conditions and interventions
Interventions
- Drug Eluting Balloon Device
- Drug eluting stent Device
- Plain old balloon angioplasty Procedure
Device · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 20, 2025
- Primary completion
- Feb 29, 2028
- Completion
- Feb 29, 2032
- Last update posted
- Aug 26, 2026
2025 – 2032
United States locations
- U.S. sites
- 47
- U.S. states
- 21
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Bernard's Medical Center | Jonesboro | Arkansas | 72401 | Recruiting |
| Scripps Memorial Hospital | La Jolla | California | 92037 | Recruiting |
| USC Medical Center | Los Angeles | California | 90033 | Recruiting |
| Cedars - Sinai Medical Center | Los Angeles | California | 90048 | Recruiting |
| University of California San Francisco | San Francisco | California | 94143 | Recruiting |
| Stanford University Medical Center | Stanford | California | 94305 | Recruiting |
| Los Robles Hospital & Medical Center | Thousand Oaks | California | 91360 | Recruiting |
| South Denver Cardiology Associates, PC | Littleton | Colorado | 80120 | Recruiting |
| The Cardiac and Vascular Institute Research Foundation | Gainesville | Florida | 32605 | Recruiting |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | Recruiting |
| Piedmont Hospital | Atlanta | Georgia | 30309 | Recruiting |
| Emory University Hospital | Atlanta | Georgia | 30322 | Recruiting |
| Wellstar Kennestone Hospital | Marietta | Georgia | 30060 | Recruiting |
| Northwestern University | Evanston | Illinois | 60208 | Recruiting |
| Endeavor Health | Glenview | Illinois | 60026 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Recruiting |
| University of Michigan Hospitals | Ann Arbor | Michigan | 48109 | Recruiting |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Recruiting |
| Corewell Health | Grand Rapids | Michigan | 49503 | Recruiting |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | Recruiting |
| St. Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | Recruiting |
| NYU Langone Hospital | Brooklyn | New York | 11220 | Recruiting |
| Mount Sinai Medical Center | New York | New York | 10029 | Recruiting |
| Columbia University Medical Center | New York | New York | 10032 | Recruiting |
| St. Francis Hospital | Roslyn | New York | 11576 | Recruiting |
| Montefiore Medical Center | The Bronx | New York | 10467 | Recruiting |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | Recruiting |
| Lindner Center for Research and Education at Christ Hospital | Cincinnati | Ohio | 45219 | Recruiting |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | Recruiting |
| Ohio Health Riverside Methodist Hospital | Columbus | Ohio | 43214 | Recruiting |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | Recruiting |
| UPMC Pinnacle | Mechanicsburg | Pennsylvania | 17050 | Recruiting |
| York Hospital | York | Pennsylvania | 17403 | Recruiting |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | Recruiting |
| Prisma Health Richland Hospital | Columbia | South Carolina | 29203 | Recruiting |
| Heart Hospital of Austin | Austin | Texas | 78705 | Withdrawn |
| Baylor Heart & Vascular Hospital | Dallas | Texas | 75226 | Recruiting |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | Recruiting |
| Vital Heart and Vein | Humble | Texas | 77338 | Recruiting |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | Recruiting |
| Methodist Healthcare System of San Antonio dba Methodist Hospital | San Antonio | Texas | 78229 | Recruiting |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | Recruiting |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | Recruiting |
| Overlake Hospital Medical Center | Bellevue | Washington | 98004 | Recruiting |
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06959524, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 26, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06959524 live on ClinicalTrials.gov.