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Drug-Coated Balloon

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Watch Drs. Robert Yeh and Ajay Kirtane discuss the AGENT IDE trial results, presented at TCT 2023.
CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.

AGENT IDE Clinical Trial

AGENT IDE is a prospective, multicenter, randomized controlled trial in the United States to evaluate the safety and effectiveness of the AGENT™ Drug-Coated Balloon (DCB) compared to balloon angioplasty in patients with in-stent restenosis (ISR).¹ 
AGENT IDE Study Design

Primary Endpoint²

AGENT DCB showed statistically superior outcomes compared to balloon angioplasty for TLF at 1-year. (17.9% versus 28.7%, P=0.0063). 
Primary Endpoint
The TLF relative risk reduction from using AGENT DCB was approximately 38%.

Additional Endpoints²

At 1-year, AGENT DCB also demonstrated statistically lower event rates:

  • 51% risk reduction in TLR (12.4% vs. 24.0%, P=0.002)
  • 49% risk reduction in TV-MI (6.4% vs 12.3%, P=0.03)
  • Zero definite/probable ST (0.0% vs. 3.9%, P=0.001)

Antiplatelet Therapy

DAPT with aspirin and a P2Y12 inhibitor was required for at least 1-month post-procedure. Antiplatelet monotherapy was continued thereafter for the entire duration of the study.