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
1 other identifier
interventional
1,616
6 countries
46
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
Longer than P75 for not_applicable
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2025
CompletedFirst Posted
Study publicly available on registry
May 6, 2025
CompletedStudy Start
First participant enrolled
August 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2032
April 28, 2026
April 1, 2026
2.5 years
April 28, 2025
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target Lesion Failure (TLF) rate
Target Lesion Failure (TLF) rate - defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death. The MI events include the Peri-Procedural MI (PPMI) according to the SCAI MI definition and the spontaneous MI according to the 4th Universal MI definition.
12-Month
Study Arms (8)
Small Vessel - Test
EXPERIMENTALSmall vessel subjects treated with AGENT DCB
Small Vessel - Control
ACTIVE COMPARATORSmall vessel subjects treated with drug eluting stent
Bifurcation - Test
EXPERIMENTALBifurcation subjects with side branches treated with AGENT DCB
Bifurcation - Control
ACTIVE COMPARATORBifurcation subjects with side branches treated with drug eluting stent or plain old balloon angioplasty
Long Lesion - Test
EXPERIMENTALLong lesion subjects treated with AGENT DCB
Long Lesion - Control
ACTIVE COMPARATORLong lesion subjects treated with drug eluting stent
Overall - Test
EXPERIMENTALAll subjects treated with AGENT DCB
Overall - Control
ACTIVE COMPARATORAll subjects treated with standard of care drug eluting stent and/or POBA
Interventions
Any commercially available DES used for standard of care.
Bifurcation side branch - POBA
AGENT DCB
Eligibility Criteria
You may qualify if:
- Subject must be at least 18 years of age.
- Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed.
- Subject is eligible for percutaneous coronary intervention (PCI).
- Subject is willing to comply with all protocol-required follow-up evaluation.
- Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.
- Target lesion is a de novo lesion located in a native coronary artery
- Target lesion must have visually estimated stenosis \> 50% and \< 100% in symptomatic subjects (\>70% and \<100% in asymptomatic subjects) prior to lesion pre-dilation.
- Target lesion must be successfully pre-dilated.
- If a non-target lesion is treated, it must be treated first and must be deemed a success.
You may not qualify if:
- Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 12 months.
- Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.).
- Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation.
- Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint.
- Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure.
- Subject is a woman who is pregnant or nursing. A pregnancy test must be performed within 7 days prior to the index procedure, except for women who definitely do not have child-bearing potential.
- Subject has left ventricular ejection fraction known to be \< 30%.
- Subject had PCI or other coronary interventions within the last 30 days.
- Subject has planned PCI or CABG after the index procedure.
- Subject had STEMI or QWMI \<72h prior to the index procedure.
- Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically unstable.
- Subject has cardiogenic shock (SBP \< 80 mmHg requiring inotropes, IABP or fluid support).
- Subject has history (within 6 months prior to the index procedure) of New York Heart Association (NYHA) class III or IV heart failure.
- Subject is considered not able to tolerate at least 30 seconds of coronary occlusion of the target lesion.
- Subject has known allergy to paclitaxel or other components of the used medical devices.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Scripps Memorial Hospital
La Jolla, California, 92037, United States
USC Medical Center
Los Angeles, California, 90033, United States
Cedars - Sinai Medical Center
Los Angeles, California, 90048, United States
University of California San Francisco
San Francisco, California, 94143, United States
Stanford University Medical Center
Stanford, California, 94305, United States
South Denver Cardiology Associates, PC
Littleton, Colorado, 80120, United States
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, 32605, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
Endeavor Health
Glenview, Illinois, 60026, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan Hospitals
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
Lindner Center for Research and Education at Christ Hospital
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio Health Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
UPMC Pinnacle
Mechanicsburg, Pennsylvania, 17050, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203, United States
Heart Hospital of Austin
Austin, Texas, 78705, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, 75226, United States
The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio, Texas, 78229, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Victorian Heart Hospital
Clayton, Victoria, 3168, Australia
Cellitinnen Krankenhaus St. Vinzenz
Cologne, 50733, Germany
Mater Private Hospital
Dublin, D07 RD8P, Ireland
Auckland City Hospital
Auckland, 1010, New Zealand
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Universitario y Politécnico La Fe
Valencia, 46026, Spain
Clínico de Valladolid
Valladolid, 47012, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Kandzari
Piedmont Heart Institute
- PRINCIPAL INVESTIGATOR
Margaret McEntegart
NYPH/CUIMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Where possible, independent outcome assessors will be masked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2025
First Posted
May 6, 2025
Study Start
August 21, 2025
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2032
Last Updated
April 28, 2026
Record last verified: 2026-04