A Phase 4 interventional study of drug-eluting stent in Coronary Artery Disease, sponsored by Cordis Corporation. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2009-12-03.
Sponsored by Cordis Corporation · Phase 4, Interventional, and Treatment
This multicenter, prospective, observational registry will evaluate the safety and performance of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent, and of all future generation of commercially approved Cordis Sirolimus-eluting Stents (SES), in routine clinical practice. Its objective is to measure the incidence and identify the predictors of acute, sub-acute and late stent thrombosis and Major Adverse Cardiac Events (MACE). Additional analyses will be performed in patient sub-populations, such as diabetes, in-stent restenosis (ISR), acute myocardial infarction (AMI) and multivessel coronary disease.
The data will be collected in consecutive subjects treated with commercially available product and following standard clinical practice. This registry will be limited to subjects who have received only the CYPHER SELECT™ Sirolimus-eluting Coronary Stent during the index procedure. While no inclusion or exclusion criteria have been specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up. All subjects should be treated according to the Instruction For Use (IFU) including conduct of the stenting procedure, application of antiplatelet medication and any other medical therapy should be provided according to local usual practice. Data collection (Electronic Data Capture), data management, statistical analyses, monitoring and core laboratory evaluations will be assigned to independent organizations.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 15,000 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Cordis Corporation is the lead sponsor of 70 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CYPHER SELECT™ Sirolimus-eluting Coronary Stent
Device: drug-eluting stent
CYPHER SELECT™ Sirolimus-eluting Coronary Stent
acute, sub-acute and late stent thrombosis; Major Adverse Cardiac Events (MACE)
Time frame: 1, 6, 12, 24 and 36 months
This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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Cordis Corporation