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
NCT ID: NCT06959524
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1616 participants
INTERVENTIONAL
2025-08-21
2032-03-31
Brief Summary
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Subjects must have a de novo target lesion located in a native coronary artery.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Small Vessel - Test
Small vessel subjects treated with AGENT DCB
Drug Eluting Balloon
AGENT DCB
Small Vessel - Control
Small vessel subjects treated with drug eluting stent
Drug eluting stent
Any commercially available DES used for standard of care.
Bifurcation - Test
Bifurcation subjects with side branches treated with AGENT DCB
Drug Eluting Balloon
AGENT DCB
Bifurcation - Control
Bifurcation subjects with side branches treated with drug eluting stent or plain old balloon angioplasty
Drug eluting stent
Any commercially available DES used for standard of care.
Plain old balloon angioplasty
Bifurcation side branch - POBA
Long Lesion - Test
Long lesion subjects treated with AGENT DCB
Drug Eluting Balloon
AGENT DCB
Long Lesion - Control
Long lesion subjects treated with drug eluting stent
Drug eluting stent
Any commercially available DES used for standard of care.
Overall - Test
All subjects treated with AGENT DCB
Drug Eluting Balloon
AGENT DCB
Overall - Control
All subjects treated with standard of care drug eluting stent and/or POBA
Drug eluting stent
Any commercially available DES used for standard of care.
Plain old balloon angioplasty
Bifurcation side branch - POBA
Interventions
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Drug Eluting Balloon
AGENT DCB
Drug eluting stent
Any commercially available DES used for standard of care.
Plain old balloon angioplasty
Bifurcation side branch - POBA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Subject has known hypersensitivity or contraindication to contrast dye that in the opinion of the investigator cannot be adequately pre-medicated.
* Subject has intolerance to antiplatelet drugs, anticoagulants required for procedure.
* Subject has platelet count \< 100k/mm3 (risk of bleeding) or \> 700k/mm3.
* Subject with renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent).
* In-stent restenosis.
* Target lesion is located within a saphenous vein or arterial graft.
* Target lesion is a total occlusion or has evidence of thrombus present in the target vessel.
* Target lesion is severely calcified by angiography or has \> 270° calcium arc on intravascular imaging or requires atherectomy.
* Subject has unprotected left main coronary artery disease (\>50% diameter stenosis) or three-vessel coronary disease requiring revascularization of all 3 vessels.
* Subject with planned treatment of lesion involving aortic ostial location.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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David Kandzari
Role: PRINCIPAL_INVESTIGATOR
Piedmont Heart Institute
Margaret McEntegart
Role: PRINCIPAL_INVESTIGATOR
NYPH/CUIMC
Locations
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USC Medical Center
Los Angeles, California, United States
South Denver Cardiology Associates, PC
Littleton, Colorado, United States
St. Francis Hospital
Roslyn, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
UPMC Pinnacle
Mechanicsburg, Pennsylvania, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Joseph Jubin, MD
Role: primary
Cinthia Tjan Bateman, MD
Role: primary
Allen Jeremias, MD
Role: primary
Amar Krishnaswamy, MD
Role: primary
Torrey Schmidt, MD
Role: primary
Robert Stoler, MD
Role: primary
Alpesh Shah, MD
Role: primary
Jorge Alvarez, MD
Role: primary
Other Identifiers
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S2530
Identifier Type: -
Identifier Source: org_study_id