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Medical Specialties > Interventional Cardiology > Coronary Interventions > PCI Product Portfolio > AGENT IDE Clinical Trial > Trial Rationale

Trial Rationale

Restenosis, the re-narrowing of a blood vessel that has previously received treatment, is a common adverse event of endovascular procedures such as angioplasty and stenting. Management of in-stent restenosis (ISR) following implantation of a coronary stent is clinically challenging, occurring in approximately 10% of PCI patients in real-world practice.1 ISR is thought to result from scar tissue or cholesterol plaque build-up. Currently, therapeutic options like drug-coated balloons (DCBs) have been approved for use to treat ISR in many parts of the world. DCBs are coated with an anti-proliferative drug, paclitaxel, that inhibits neointimal growth, thereby reducing the rate of restonsis.2

Data from numerous clinical trials and registries suggest that DCB may be a good treatment for ISR.3 Drug coated balloons allow for drug transfer without introducing a new layer of metal and may fill an unmet need for many patients with coronary in-stent restenosis. The German consensus group recommends DCB treatment for ISR.4 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.5

In-Stent Restenosis
 

Why AGENT DCB?

The AGENT™ Drug-Coated Balloon (DCB) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA). It is the first coronary DCB to be evaluated in a randomized clinical trial 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.

AGENT DCB
 

Why AGENT IDE Clinical Trial?

The AGENT Investigational Device Exemption (IDE) trial will evaluate the safety and effectiveness of the AGENT Drug-Coated Balloon compared to balloon angioplasty (POBA) in patients with in-stent restenosis of a previously treated lesion up to 36mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.

Explore the Trial
AGENT Diameter - 36mm length/2.0->4.0mm Diameter
 
 
Site Locator

Find a Trial Site

Boston Scientific has selected sites throughout the U.S. to be AGENT IDE investigational centers. If you have a candidate in mind, view the active site list on www.clinicaltrials.gov (NCT04647253), and reach out to a study physician near you to discuss the trial.
Site Locator
 
 
 
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