AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease
Boston Scientific Corporation
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.
Description
The study will also contain a PK sub study and an IVUS sub study.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 C…
Interventions
- DeviceDrug Eluting Balloon
AGENT DCB
- DeviceDrug eluting stent
Any commercially available DES used for standard of care.
- ProcedurePlain old balloon angioplasty
Bifurcation side branch - POBA
Locations (50)
- Scripps Memorial HospitalLa Jolla, California
- USC Medical CenterLos Angeles, California
- Cedars - Sinai Medical CenterLos Angeles, California
- University of California San FranciscoSan Francisco, California
- Stanford University Medical CenterStanford, California
- South Denver Cardiology Associates, PCLittleton, Colorado