NCT00623441 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Münzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE; ENDEAVOR II Investigators
Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006 Aug 22;114(8):798-806. Epub 2006 Aug 14.
Jain AK, Lotan C, Meredith IT, Feres F, Zambahari R, Sinha N, Rothman MT; E-Five Registry Investigators
Twelve-month outcomes in patients with diabetes implanted with a zotarolimus-eluting stent: results from the E-Five Registry. Heart. 2010 Jun;96(11):8
Jain AK, Meredith IT, Lotan C, Rothman MT, Pateraki S; E-Five Investigators
Real-world safety and efficacy of the endeavor zotarolimus-eluting stent: early data from the E-Five Registry. Am J Cardiol. 2007 Oct 22;100(8B):77M-83M.
Lotan C, Meredith IT, Jain A, Feres F, Firszt A, Garcia AF, Rothman MT
Clinical outcomes by geographic region for patients implanted with the zotarolimus-eluting stent. Arq Bras Cardiol. 2011 May;96(5):353-62. Epub 2011 Apr 1. English, Portuguese, Spanis
Lotan C, Meredith IT, Mauri L, Liu M, Rothman MT; E-Five Investigators
Safety and effectiveness of the Endeavor zotarolimus-eluting stent in real-world clinical practice: 12-month data from the E-Five registry. JACC Cardiovasc Interv. 2009 Dec;2(12):1227
Meredith I, Rothman M, Erglis A, Parikh K, Lotan C; E-Five Investigators
Extended follow-up safety and effectiveness of the Endeavor zotarolimus-eluting stent in real-world clinical practice: two-year follow-up from the E-Five Registry. Catheter Cardiova

E-Five Registry: To Evaluate the 'Real World' Clinical Performance of the Medtronic Endeavor ABT-578 Eluting Coronary Stent System; A Prospective, Multicenter Registry

Details for clinical trial NCT00623441

Clinical trial NCT00623441 - References