AGENT Investigational Device Exemption (IDE)
Clinical Trial

Why AGENT IDE Trial?

Management of in-stent restenosis (ISR) following implantation of a coronary stent is clinically challenging. Drug-coated balloons (DCBs) may fill an unmet need for patients with ISR. The AGENT IDE clinical trial will compare AGENT DCB to standard balloon angioplasty for the treatment of patients with re-narrowed blood vessel(s).

What is Required of Me in the Trial?

By joining this study:

• Information will be recorded before and during your procedure, and at the time of your discharge from the hospital.


• This is a randomized study. If you are eligible to participate, you will be randomly assigned to treatment with either the AGENT drug-coated balloon or a standard non-drug coated balloon. You will not know which balloon you were treated with for the duration of the study.


• You will be required to attend follow‑up visits with your doctor at 30 days, 6 months, 12 months, and then once every year for a total of 5 years after your balloon angioplasty procedure. Some follow‑up appointments will be done at your doctor’s office and some may be done by telephone. Your participation in the study will be complete after your five-year follow-up visit.


• You will receive medication that will help to decrease the chance of blood clots forming during and after the procedure. These medications are routinely used in patients who undergo angioplasty procedures and are not considered investigational. Your doctor will tell you which medications to take and for how long.


• You will be expected to tell your study doctor about any changes to your medications, any other medical treatments and/or medical problems or concerns that you may have, including any hospital admissions, even if they are not related to the study.