Status:
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
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Coronary Arterial Disease (CAD)
de Novo Lesions in Native Coronary Arteries
Eligibility:
All Genders
18+ years
Phase:
NA
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 c...
Detailed Description
The study will also contain a PK sub study and an IVUS sub study.
Eligibility Criteria
Inclusion
- Clinical
- 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.
- Angiographic
- 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.
- Clinical
Exclusion
- 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.
- 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).
- Angiographic
Key Trial Info
Start Date :
August 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2032
Estimated Enrollment :
1616 Patients enrolled
Trial Details
Trial ID
NCT06959524
Start Date
August 21 2025
End Date
March 1 2032
Last Update
January 7 2026
Active Locations (22)
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1
USC Medical Center
Los Angeles, California, United States, 90033
2
Stanford University Medical Center
Stanford, California, United States, 94305
3
South Denver Cardiology Associates, PC
Littleton, Colorado, United States, 80120
4
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, United States, 32605