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Clinical Trials/NCT00866398
NCT00866398
Completed
Not Applicable

Economic Evaluation German Drug-Eluting Stent Registry

Charite University, Berlin, Germany0 sites3,973 target enrollmentDecember 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Heart Disease
Sponsor
Charite University, Berlin, Germany
Enrollment
3973
Primary Endpoint
Cost equivalence of drug-eluting coronary stents versus bare metal stents
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2005
End Date
March 2008
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cost equivalence of drug-eluting coronary stents versus bare metal stents

Time Frame: 12 months

Secondary Outcomes

  • MACCE(12 months)
  • Quality of life(12 months)

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