Tests a drug-coated balloon versus standard stents for coronary artery disease
Compares a drug-coated balloon with standard stent treatment in adults with coronary artery disease.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Cologne, Lahr, and Trier, GermanySee the 3 sites
Where in Germany
- Cellitinnen Krankenhaus St. VinzenzCologne, GermanyTaking people
- MediClin Herzzentrum LahrLahr, GermanyNo longer taking part
- Krankenhaus der Barmherzigen BrüderTrier, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Boston Scientific Corporation
- Trial code
- NCT06959524
- Record updated
- 20 October 2026
- Original description
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.Read full original descriptionShow less
AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease
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.
Clinical Inclusion Criteria:; 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 Inclusion Criteria:; 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 Criteria:; 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.) as assessed by Investigator; 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% within the last 12 months; Subject had PCI or other coronary interventions within the last 3 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 ACS 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); Subject has previous or planned (within 30 days) TAVR; Previous cardiac transplant; Angiographic Exclusion Criteria:; 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 or requires intravascular lithotripsy; 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 <3 mm from aorta; Target Lesion is in a previously jailed side branch.