An observational study in Coronary Heart Disease, sponsored by Charite University, Berlin, Germany. Completed. Per ClinicalTrials.gov, last updated 2011-01-17.
Sponsored by Charite University, Berlin, Germany · Observational
Since the advent of coronary stents, in-stent restenosis has proven to be the major limitation of interventional cardiology, occurring in as many as 30% of patients. Drug-eluting stents are specifically designed to prevent the problem of in-stent restenosis. They consist of a selective anti-proliferative drug, sirolimus, a controlled-release polymer, and a closed-cell stent delivery platform. Upon placement, sirolimus elutes into the vessel wall and stops the process of neointimal hyperplasia, thereby significantly reducing the incidence of in-stent restenosis.
The study "Economic Evaluation of the German Drug-Eluting Stent Registry" examines the cost-effectiveness of drug-eluting stents compared to bare-metal stents (BMS) in patients with coronary stenosis. The goal of the study is to examine whether the guideline-supported implantation of SES, despite the higher initial cost, improves the quality and economic outcomes of the treatment of patients with coronary stenosis. Secondarily, the study evaluates patient quality of life, impairment of daily activities, and re-intervention rates.
2,867 studies on the registry are indexed under Coronary Disease; 309 are open to participants now.
This study's enrollment of 3,973 is above the median of 465 across 958 observational studies indexed under Coronary Disease.
Browse Coronary Disease studies →Charite University, Berlin, Germany is the lead sponsor of 854 studies on the registry; 127 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with coronary heart disease, eligible for stent implantation.
Inclusion Criteria:
Additional inclusion criteria BMS cohort:
Patients receiving drug-eluting stent
Patients receiving bare metal stent
Cost equivalence of drug-eluting coronary stents versus bare metal stents
Time frame: 12 months
MACCE
Time frame: 12 months
Quality of life
Time frame: 12 months
No study locations are listed for this record.
The record gives a start of Dec 2005, a primary completion of Oct 2007 and a completion of Mar 2008. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany →