AGENT™

Paclitaxel Coated-PTCA Balloon Catheter

AGENT ISR is the first DCB study to randomize 1:1 two different drug formulations.

The AGENT In-Stent Restenosis study compares the novel AGENT DCB to the commercially-available SeQuent® Please DCB. This is the first head-to-head clinical study of two DCBs with different drug formulations

Background

  • Treatment of patients with in-stent restenosis (ISR) is an important clinical problem occurring in approximately 10% of PCI patients in real-world practice
  • ISR is thought to result from aggressive neointimal proliferation or neoatherosclerosis
  • Currently, drug-eluting stents and drug-coated balloons (DCB) are used to treat ISR
  • DCB’s rapidly transfer the anti-proliferative drug, Paclitaxel, to the arterial vessel wall without adding another metal layer

Study Design


Clinical Results1,2

  • Based on the data released at EuroPCR 2018, AGENT DCB showed lower event rates and 21% lower TLF at 12 months (9.2% vs. 11.7%)
  • AGENT Drug-Coated Balloon met its primary endpoint of non-inferiority of in-stent late loss compared to the SeQuent Please DCB. 
  • In addition, the AGENT DCB was numerically better in all clinical endpoints including TVF and ST.
     
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