Cardiac stent for patients that cannot take dual anti-platelet therapy long-term

Trial ID:
IRB-17-6955
Matthew J Price, M.D.
Coronary artery stents have been available for more than 20 years and have been proven to be safe and effective. The design is continuously improved to ensure better outcomes for patients. Most stents currently used contain an anti-inflammatory drug to reduce the risk of the artery re-narrowing, called drug-eluting stents. Dual antiplatelet therapy (DAPT) is generally required after stent placement to prevent blood from clotting within the stent, which is typically 6 to 12 months for drug-eluting stents; however, some patients cannot take DAPT for more than one month due to the risk of bleeding. <br><br>The BioFreedom stent is one of the newest generation of drug-coated stents. The study will evaluate if treatment with the drug coated stent is safe and effective after one month of DAPT. All patients in the study will receive the BioFreedom stent and be followed for 3 years. Office follow-up visits will be required after the procedure at 1 month, 6 months and 12 month with telephone fol

Inclusion Criteria

  • Be scheduled to have a cardiac stent implantation procedure
  • Have medical reasons they cannot take dual antiplatelet treatment (DAPT) for more than 1 month;
  • Be willing to comply with the required follow-up schedule
  • Meet all other eligibility criteria

Exclusion Criteria

  • Be pregnant
  • Have had a coronary intervention procedure within the last 12 months
  • Be participating in another clinical trial

Additional Info

  • This stent delivers the anti-inflammatory drug differently than other drug-coated stents and might reduce the course of DAPT that is required after the procedure because the healing process may be faster than with a drug-eluting stent.

Contact Info:

  • Heather Catchpole
  • catchpole.heather@scrippshealth.org
  • 858-824-4248