Actively Recruiting
AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease
Led by Boston Scientific Corporation · Updated on 2026-06-03
1616
Participants Needed
55
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the AGENT Drug-Coated Balloon (DCB) compared to standard percutaneous coronary intervention (PCI) treatments, which include drug eluting stents (DES) and/or balloon angioplasty, for patients with new (de novo) coronary artery lesions. This prospective, multicenter, open-label randomized controlled study focuses on patients with de novo target lesions in native coronary arteries. The study also includes pharmacokinetic (PK) and intravascular ultrasound (IVUS) sub-studies to gather additional data. Participants will be assigned to one of several groups receiving different treatments: small vessel subjects treated with AGENT DCB or DES, bifurcation subjects with side branches treated with AGENT DCB or DES/balloon angioplasty, and long lesion subjects treated with AGENT DCB or DES. Treatments are delivered via PCI, and the study compares the AGENT DCB device to the current standard of care using commercially available DES and plain old balloon angioplasty (POBA). During the study, participants will undergo regular follow-ups to monitor safety and treatment effectiveness. Researchers will assess the primary outcome of target lesion failure (TLF) rate at 12 months. Additional evaluations include angiographic assessments and adherence to protocol-required follow-ups. The total duration and detailed schedule of assessments will be conducted to ensure comprehensive monitoring of all subjects.
CONDITIONS
Brief 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 before any trial-specific tests or procedures.
- 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 reliable contraception from screening through 12 months after the 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) before lesion pre-dilation.
- Target lesion must be successfully pre-dilated.
- If a non-target lesion is treated, it must be treated first and deemed a success.
You will not qualify if you...
- Subject has serious illness (e.g. cancer, congestive heart failure) 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 study not yet completed.
- Subject intends to join another investigational study within 12 months after the procedure.
- Subject is pregnant or nursing; pregnancy test required within 7 days before procedure unless no child-bearing potential.
- Left ventricular ejection fraction is less than 30%.
- Subject had PCI or other coronary interventions within last 30 days.
- Subject has planned PCI or coronary artery bypass graft (CABG) after the procedure.
- Subject had STEMI or QWMI less than 72 hours before the procedure.
- Subject presents with unstable NSTEMI, ongoing chest pain, or is hemodynamically unstable.
- Subject has cardiogenic shock requiring support.
- History of NYHA class III or IV heart failure within 6 months before procedure.
- Subject cannot tolerate at least 30 seconds of coronary occlusion of the target lesion.
- Subject is allergic to paclitaxel or device components.
- Subject has hypersensitivity or contraindication to contrast dye.
- Subject has intolerance to required antiplatelet or anticoagulant drugs.
- Platelet count is less than 100,000/mm3 or greater than 700,000/mm3.
- Renal insufficiency (creatinine ≥ 2.0 mg/dl) or dialysis-dependent.
- Target lesion is in-stent restenosis.
- Target lesion is within saphenous vein or arterial graft.
- Target lesion is total occlusion or has thrombus in vessel.
- Target lesion is severely calcified or requires atherectomy.
- Subject has unprotected left main coronary artery disease or three-vessel disease needing revascularization.
- Planned treatment involves aortic ostial lesion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-procedure period
Participants undergo percutaneous coronary intervention (PCI) using either the AGENT drug-coated balloon or standard of care devices such as drug eluting stents or balloon angioplasty, depending on their assigned group.
1 procedure visit and approximately 6 post-procedure follow-up visits
Duration - Up to 12 months after treatment
Participants are monitored for safety and effectiveness outcomes, including target lesion failure, with scheduled follow-up visits extending up to 12 months after the procedure.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 55 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
Los Robles Hospital & Medical Center
Thousand Oaks, California, United States, 91360
Actively Recruiting
7
South Denver Cardiology Associates, PC
Littleton, Colorado, United States, 80120
Actively Recruiting
8
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, United States, 32605
Actively Recruiting
9
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Actively Recruiting
10
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
11
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Actively Recruiting
12
Endeavor Health
Glenview, Illinois, United States, 60026
Actively Recruiting
13
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
14
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
15
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
16
University of Michigan Hospitals
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
17
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
18
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
19
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
20
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
21
NYU Langone Hospital
Brooklyn, New York, United States, 11220
Actively Recruiting
22
Mount Sinai Medical Center
New York, New York, United States, 10029
Actively Recruiting
23
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
24
St. Francis Hospital
Roslyn, New York, United States, 11576
Actively Recruiting
25
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
26
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Actively Recruiting
27
Lindner Center for Research and Education at Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
28
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
29
Ohio Health Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Actively Recruiting
30
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
31
UPMC Pinnacle
Mechanicsburg, Pennsylvania, United States, 17050
Actively Recruiting
32
York Hospital
York, Pennsylvania, United States, 17403
Actively Recruiting
33
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
34
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
35
Heart Hospital of Austin
Austin, Texas, United States, 78705
Active, Not Recruiting
36
Baylor Heart & Vascular Hospital
Dallas, Texas, United States, 75226
Actively Recruiting
37
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Actively Recruiting
38
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Actively Recruiting
39
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio, Texas, United States, 78229
Actively Recruiting
40
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
41
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Actively Recruiting
42
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
Actively Recruiting
43
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Not Yet Recruiting
44
Victorian Heart Hospital
Clayton, Victoria, Australia, 3168
Not Yet Recruiting
45
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
46
Fuwai Hospital Chinese Academy of Medical Sciences
Beijin, Beijin, China, 100000
Actively Recruiting
47
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangzhou, China, 510080
Actively Recruiting
48
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
49
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China, 710061
Actively Recruiting
50
Cellitinnen Krankenhaus St. Vinzenz
Cologne, Germany, 50733
Actively Recruiting
51
Mater Private Hospital
Dublin, Ireland, D07 RD8P
Actively Recruiting
52
Auckland City Hospital
Auckland, New Zealand, 1010
Not Yet Recruiting
53
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Actively Recruiting
54
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026
Actively Recruiting
55
Clínico de Valladolid
Valladolid, Spain, 47012
Actively Recruiting
Research Team
B
Beth Lawson
K
Kim Pena-Trast
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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