Medtronic Completes Patient Enrollment in ENDEAVOR III Clinical Trial

Strategic Insights -

Medtronic has completed patient enrollment in the ENDEAVOR III clinical trial in the United States, marking a significant milestone in the company's drug-eluting stent development program. The trial aims to evaluate the safety and efficacy of the Endeavor Drug Eluting Coronary Stent versus the Cypher Sirolimus-eluting stent, with 436 patients enrolled and a primary endpoint of in-segment late lumen loss at 8 months. The study will provide valuable data to support product approvals globally, building on the success of previous ENDEAVOR trials.

Key Takeaways:

  • The ENDEAVOR III clinical trial is a randomized study evaluating the safety and efficacy of the Endeavor Drug Eluting Coronary Stent versus the Cypher Sirolimus-eluting stent, with 436 patients enrolled.
  • The primary endpoint of the study is in-segment late lumen loss at 8 months, with secondary endpoints including target lesion revascularization, target vessel revascularization, and target vessel failure rates at 9 months, and angiographic binary restenosis rate at 8 months.
  • The co-principal investigators of ENDEAVOR III are Martin B. Leon, MD, of Columbia University Hospital, New York, and David E. Kandzari, MD, Duke University Medical Center, Durham, North Carolina.
  • The trial is the third in a series of clinical studies designed to gather comprehensive data on the safety and efficacy of the Endeavor Drug Eluting Coronary Stent, with Medtronic also conducting trials ENDEAVOR I, ENDEAVOR II, and ENDEAVOR IV.
  • Medtronic, Inc., is a medical technology company providing lifelong solutions for people with chronic disease, with headquarters in Minneapolis, Minnesota.

Statistics:

  • 436 patients were enrolled in the ENDEAVOR III clinical trial.
  • The primary endpoint of in-segment late lumen loss was to be evaluated at 8 months.
  • Secondary endpoints included target lesion revascularization, target vessel revascularization, and target vessel failure rates at 9 months, and angiographic binary restenosis rate at 8 months.
  • The Co-principal investigators of ENDEAVOR III are Martin B. Leon, MD, and David E. Kandzari, MD.

Sources:

  • "Medtronic Completes Enrollment for ENDEAVOR III Clinical Trial, Newark, NJ, USA, October 10, 2004", NewsRx.com & NewsRx.net
  • "Endeavor III Clinical Trial Overview", Medtronic website.