AGENT™

Drug-Coated Balloon

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Watch Drs. Robert Yeh and Ajay Kirtane discuss the AGENT IDE trial results, presented at TCT 2023.
AGENT IDE Trial

The AGENT IDE Clinical Trial showed that AGENT DCB is superior to conventional balloon angioplasty in reducing target lesion failure for the treatment of coronary in-stent restenosis (ISR).1

 

Expanding Clinical Evidence Beyond ISR

100,000+ patients have been treated with AGENT DCB globally, with over 4,400 patients evaluated or currently undergoing evaluation with AGENT DCB.3 Patients are at the center of everything we do at Boston Scientific as we continue to research and advance science for life. That’s why we sponsored the AGENT DCB STANCE Trial.

This trial is designed to assess the safety and effectiveness of the AGENT DCB compared to the standard of care – percutaneous coronary intervention (PCI) treatment with drug-eluting stents (DES) and/or balloon angioplasty – in patients with de novo coronary lesions.

Patients enrolling in the trial must have a de novo target lesion located in a native coronary artery. The study is examining de novo lesions in small vessels, bifurcations, and long lesions. The primary endpoint is Target Lesion Failure (TLF) at 12 months.

Visit clinicaltrials.gov for more information on trial sites and expected completion. 

 

AGENT IDE Clinical Trial

AGENT Investigational Device Exemption (IDE) is a prospective, multicenter, randomized controlled trial in the United States to evaluate the safety and effectiveness of the AGENT™ Drug-Coated Balloon compared to balloon angioplasty in patients with ISR. At one year, AGENT DCB demonstrated statistically lower event rates1:
 
50% risk reduction in TLR

50% risk reduction in TLR

(13.0% vs. 24.7%, P=0.0005)

49% risk reduction in TV-MI

49% risk reduction in TV-MI

(5.8% vs. 11.1%, P=0.023)

Zero definite/probable ST

Zero definite/probable ST

(0.0% vs. 3.2%, P=0.0004)

AGENT IDE Study Design
 
 

Primary Endpoint²

AGENT DCB showed statistically superior outcomes compared to balloon angioplasty for TLF at 1-year. (17.9% versus 28.6%, P=0.003). 
Primary Endpoint
 
The TLF relative risk reduction from using AGENT DCB was approximately 38%.
 
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