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Economic Evaluation German Drug-Eluting Stent Registry

This study has been completed.
Sponsor:
Collaborators:
IKKF GmbH
IHF Ludwigshafen
Cordis Med. Apparate GmbH
Boston Scientific Corporation
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00866398
First received: March 19, 2009
Last updated: January 14, 2011
Last verified: January 2011
History of Changes

March 19, 2009
January 14, 2011
December 2005
October 2007   (final data collection date for primary outcome measure)
Cost equivalence of drug-eluting coronary stents versus bare metal stents [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00866398 on ClinicalTrials.gov Archive Site
  • MACCE [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ]
Same as current
 
 
 
Economic Evaluation German Drug-Eluting Stent Registry
Economic Evaluation German Drug-Eluting Stent Registry

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.
 
Observational
Observational Model: Cohort
Time Perspective: Prospective
 
Non-Probability Sample

Patients with coronary heart disease, eligible for stent implantation.
Coronary Heart Disease
 
  • 1 DES
    Patients receiving drug-eluting stent
  • 2 BMS
    Patients receiving bare metal stent
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3973
March 2008
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Indication for coronary stent implantation

  • Additional inclusion criteria BMS cohort:

    • Acute Coronary Syndrome
    • Diabetes Mellitus
    • Previous Percutaneous Coronary Intervention/Coronary Artery Bypass Graft
    • 3-Vessel Disease
Both
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00866398
008
No
Stefan N Willich, MD, MPH, MBA, Charité - Universitätsmedizin Berlin
Charite University, Berlin, Germany
  • IKKF GmbH
  • IHF Ludwigshafen
  • Cordis Med. Apparate GmbH
  • Boston Scientific Corporation
Study Director: Stefan N Willich, Prof, MD, MPH Charité University Medical Center
Charite University, Berlin, Germany
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP