NCT00232739 - 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)

Moses JW, Nikolsky E, Mehran R, Cambier PA, Bachinsky WB, Leya F, Kuntz RE, Popma JJ, Schleckser P, Wang H, Cohen SA, Leon MB; SIRIUS 2
25 Investigators. Safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in the treatment of patients with de novo native coronary artery lesions: the SIRIUS 2.25 trial. Am J Cardiol. 2006 Dec 1;98(11):1455-60. Epub 2006 Oct 13.

A Multicenter, Non-Randomized Study of the 2.25mm Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions

Details for clinical trial NCT00232739

Clinical trial NCT00232739 - References