Skip to main content

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

AGENT IDE Clinical Trial

Why AGENT IDE Clinical Trial?

  • To compare the safety and effectiveness of the AGENT™ Drug-Coated Balloon (DCB) to balloon angioplasty (POBA) with standard (non-drug coated) balloons.

  • It is the first randomized trial for a coronary drug-coated balloon in the United States.

  • For interventional cardiologists who perform complex PCI procedures, the AGENT DCB device may fill an unmet need for patients with coronary in-stent restenosis (ISR).
 

Trial Design and Primary Endpoint

AGENT Investigational Device Exemption (IDE) is a randomized comparison of the AGENT Drug Coated Balloon vs standard balloon angioplasty or POBA for the treatment of in-stent restenosis.

Trial design and primary endpoint

Trial Timeline

See below for an overview of both the AGENT DCB and standard angioplasty control group treatment timelines.

Trial Timeline
 
 

Patient Brochure

View the brochure created to give your trial candidates an overview of the AGENT IDE clinical trial.

View Brochure
 
AGENT IDE Patient Brochure
 
Lifestyle image, patient in kitchen
 

Patient Selection

The AGENT IDE trial seeks to demonstrate AGENT DCB technology can be used as an alternative to repeat stenting in patients diagnosed with ISR.

Patient Selection
 
 
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
 
 
 
Next: Trial Patient Selection
 
Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.
 
Top