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Drug-Coated Balloon

The AGENT Drug-Coated Balloon, with its innovative TransPax™ coating technology¹, is designed to provide a targeted, therapeutic dose of anti-proliferative Paclitaxel to the coronary lesion². It was also designed to minimize downstream particulates while maintaining the outstanding deliverability you’ve come to expect with Boston Scientific products.³

CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.

AGENT IDE Clinical Trial

The AGENT Investigational Device Exemption (IDE) trial is evaluating the safety and effectiveness of the AGENT™ Drug-Coated Balloon (DCB) compared to balloon angioplasty in patients with in-stent restenosis (ISR).

It is the first randomized trial for a coronary drug-coated balloon in the United States. ISR is a growing issue and previous studies outside of the U.S. have demonstrated good angiographic and clinical results with AGENT DCB.

The AGENT DCB device is intended to fill an unment need for patients with coronary ISR of a previously treated lesion up to 26mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter. 


Trial Rationale

Approximately 10% of PCIs are ISR cases and current treatment options include layering of additional stents, balloon angioplasty and radiation, all of which introduce potential risks for patients.⁴ There is a need for technology that can provide a better option for patients.

Data from numerous clinical trials and registries suggest that DCB may be a good treatment for ISR.⁵ AGENT was designed to provide a targeted therapeutic dose of paclitaxel to the lesion without introducing an additional metallic layer.⁶ Drug-coated balloons may fill an unmet need for many patients with coronary in-stent restenosis.

The German consensus group recommends DCB treatment for ISR.⁷ Similarly, the Guidance on Myocardial Revascularization released by the European Society of Cardiology {ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) recommends DCB treatment as an alternative option to treat ISR.⁸


Trial Design and Primary Endpoint

AGENT IDE is a randomized comparison of the AGENT Drug-Coated Balloon vs. standard balloon angioplasty for the treatment of in-stent restenosis.
Trial design