AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to
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 ball
| Condition(s) | Coronary Arterial Disease (CAD), de Novo Lesions in Native Coronary Arteries |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 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. |
| Who can participate | 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 asy |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Boston Scientific Corporation |
| Locations | La Jolla, California, United States; Los Angeles, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Stanford, California, United States; Thousand Oaks, California, United States (+49 more sites) |
| Start date | 2025-08-21 |
| NCT ID | NCT06959524 |
| Official listing | https://clinicaltrials.gov/study/NCT06959524 |