NCT01761591 - 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)

de Ribamar Costa J, Abizaid A, Stella P, Fernandez A, Granada J, Feres F, Serruys P
Preliminary results of the svelte trial: first-in-man assessment of the novel acrobat™ SOAW (Stent-On-A-Wire) coronary system. J Am Coll Cardiol. 2011;57(14s1):E1658-E1658. doi:10.1016/S0735-1097(11)61658-6
Piscione F, Piccolo R, Cassese S, Galasso G, D'Andrea C, De Rosa R, Chiariello M
Is direct stenting superior to stenting with predilation in patients treated with percutaneous coronary intervention? Results from a meta-analysis of 24 randomised controlled trials. Heart. 2010 Apr;96(8):588-94. doi: 10.1136/hrt.2009.183277. Review.
Shao C, Stella PR, Agostoni P
Complex made easy: left anterior descending artery trifurcation lesion completely treated with a single device. J Invasive Cardiol. 2012 Aug;24(8):E164-6.

Acrobat Coronary Stent System Effectiveness European Study (European Multicenter Effectiveness Randomized Study of Svelte Medical Systems Acrobat Stent on a Wire Compared to Other BMS PCI in de Novo Coronary Lesions) ACES Trial

Details for clinical trial NCT01761591

Clinical trial NCT01761591 - References