Actively Recruiting
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
Led by Boston Scientific Corporation · Updated on 2026-05-07
1616
Participants Needed
50
Research Sites
340 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject must be at least 18 years of age.
- Subject (or legal guardian) understands the trial requirements and provides written informed consent.
- Subject is eligible for percutaneous coronary intervention (PCI).
- Subject is willing to comply with all required follow-up evaluations.
- Women of child-bearing potential must agree to use reliable contraception from screening through 12 months after the procedure.
- Target lesion is a new (de novo) lesion in a native coronary artery.
- Target lesion has visually estimated stenosis > 50% and < 100% in symptomatic subjects, or > 70% and < 100% in asymptomatic subjects before pre-dilation.
- Target lesion must be successfully pre-dilated.
- Non-target lesions, if treated, must be treated first and deemed successful.
You will not qualify if you...
- Subject has serious medical illness reducing life expectancy to less than 12 months.
- Subject has current substance abuse problems.
- Subject has planned procedures that may cause non-compliance or confound data.
- Subject is participating in another investigational drug or device study that has not reached its primary endpoint.
- Subject plans to participate in another investigational study within 12 months after the procedure.
- Subject is pregnant or nursing; pregnancy test required within 7 days prior to procedure unless no child-bearing potential.
- Subject has left ventricular ejection fraction < 30%.
- Subject had PCI or other coronary intervention within the last 30 days.
- Subject has planned PCI or coronary artery bypass graft (CABG) after the procedure.
- Subject had STEMI or Q-wave myocardial infarction within 72 hours prior to procedure.
- Subject presents with NSTEMI and rising biomarkers, ongoing chest pain, or is hemodynamically unstable.
- Subject has cardiogenic shock requiring inotropes, balloon pump, or fluid support.
- Subject has history within 6 months of NYHA class III or IV heart failure.
- Subject cannot tolerate at least 30 seconds of coronary occlusion of the target lesion.
- Subject has allergy to paclitaxel or device components.
- Subject has hypersensitivity or contraindication to contrast dye that cannot be pre-medicated.
- Subject has intolerance to required antiplatelet or anticoagulant drugs.
- Subject has platelet count < 100,000/mm3 or > 700,000/mm3.
- Subject has renal insufficiency with creatinine ≥ 2.0 mg/dl or is dialysis dependent.
- In-stent restenosis at target lesion.
- Target lesion is in a saphenous vein or arterial graft.
- Target lesion is a total occlusion or has thrombus present.
- Target lesion is severely calcified or requires atherectomy.
- Subject has unprotected left main coronary artery disease > 50% stenosis or three-vessel disease requiring revascularization.
- Target lesion involves aortic ostial location planned for treatment.
AI-Screening
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Trial Site Locations
Total: 50 locations
1
Scripps Memorial Hospital
La Jolla, California, United States, 92037
Actively Recruiting
2
USC Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Cedars - Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
5
Stanford University Medical Center
Stanford, California, United States, 94305
Actively Recruiting
6
South Denver Cardiology Associates, PC
Littleton, Colorado, United States, 80120
Actively Recruiting
7
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, United States, 32605
Actively Recruiting
8
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Actively Recruiting
9
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
10
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Actively Recruiting
11
Endeavor Health
Glenview, Illinois, United States, 60026
Actively Recruiting
12
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
13
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
14
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
15
University of Michigan Hospitals
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
16
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
17
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
18
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
19
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
20
Mount Sinai Medical Center
New York, New York, United States, 10029
Actively Recruiting
21
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
22
St. Francis Hospital
Roslyn, New York, United States, 11576
Actively Recruiting
23
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
24
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Actively Recruiting
25
Lindner Center for Research and Education at Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
26
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
27
Ohio Health Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Actively Recruiting
28
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
29
UPMC Pinnacle
Mechanicsburg, Pennsylvania, United States, 17050
Actively Recruiting
30
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
31
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
32
Heart Hospital of Austin
Austin, Texas, United States, 78705
Actively Recruiting
33
Baylor Heart & Vascular Hospital
Dallas, Texas, United States, 75226
Actively Recruiting
34
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Actively Recruiting
35
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Actively Recruiting
36
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio, Texas, United States, 78229
Actively Recruiting
37
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
38
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
Actively Recruiting
39
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Not Yet Recruiting
40
Victorian Heart Hospital
Clayton, Victoria, Australia, 3168
Not Yet Recruiting
41
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
42
Fuwai Hospital Chinese Academy of Medical Sciences
Beijin, Beijin, China, 100000
Actively Recruiting
43
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangzhou, China, 510080
Actively Recruiting
44
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
45
Cellitinnen Krankenhaus St. Vinzenz
Cologne, Germany, 50733
Actively Recruiting
46
Mater Private Hospital
Dublin, Ireland, D07 RD8P
Actively Recruiting
47
Auckland City Hospital
Auckland, New Zealand, 1010
Not Yet Recruiting
48
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Actively Recruiting
49
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026
Actively Recruiting
50
Clínico de Valladolid
Valladolid, Spain, 47012
Actively Recruiting
Research Team
B
Beth Lawson
CONTACT
K
Kim Pena-Trast
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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