NCT00288535 - 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)

Al Suwaidi J, Yeh W, Cohen HA, Detre KM, Williams DO, Holmes DR Jr
Immediate and one-year outcome in patients with coronary bifurcation lesions in the modern era (NHLBI dynamic registry). Am J Cardiol. 2001 May 15;87(10):1139-44.
Colombo A, Moses JW, Morice MC, Ludwig J, Holmes DR Jr, Spanos V, Louvard Y, Desmedt B, Di Mario C, Leon MB
Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation. 2004 Mar 16;109(10):1244-9. Epub 2004 Feb 23.
Holmes DR, Leon MB, Moses JW et al
One-year follow-up of the SIRIUS study : a randomized study with the sirolimus-eluting Bx Velocity in the treatment of patients with denovo native coronary artery lesions. J Am Coll Cardiol 2003;41:32A
Lefèvre T, Louvard Y, Morice MC, Dumas P, Loubeyre C, Benslimane A, Premchand RK, Guillard N, Piéchaud JF
Stenting of bifurcation lesions: classification, treatments, and results. Catheter Cardiovasc Interv. 2000 Mar;49(3):274-83.
Yamashita T, Nishida T, Adamian MG, Briguori C, Vaghetti M, Corvaja N, Albiero R, Finci L, Di Mario C, Tobis JM, Colombo A
Bifurcation lesions: two stents versus one stent--immediate and follow-up results. J Am Coll Cardiol. 2000 Apr;35(5):1145-51.

Prospective, Randomized, Single-Center Evaluation of the Cypher™ Sirolimus Eluting Coronary Stent System in the Treatment of Bifurcated Coronary Lesions

Details for clinical trial NCT00288535

Clinical trial NCT00288535 - References