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Economic Evaluation German Drug-Eluting Stent Registry
This study has been completed.
First Received: March 19, 2009   No Changes Posted
Sponsors and Collaborators: Charite University, Berlin, Germany
IKKF GmbH
IHF Ludwigshafen
Cordis Med. Apparate GmbH
Boston Scientific Corporation
Information provided by: Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00866398
  Purpose

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.


Condition
Coronary Heart Disease

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Economic Evaluation German Drug-Eluting Stent Registry

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Cost equivalence of drug-eluting coronary stents versus bare metal stents [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MACCE [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 3973
Study Start Date: December 2005
Study Completion Date: March 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1 DES
Patients receiving drug-eluting stent
2 BMS
Patients receiving bare metal stent

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Study Population

Patients with coronary heart disease, eligible for stent implantation.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866398

Sponsors and Collaborators
Charite University, Berlin, Germany
IKKF GmbH
IHF Ludwigshafen
Cordis Med. Apparate GmbH
Boston Scientific Corporation
Investigators
Study Director: Stefan N Willich, Prof, MD, MPH Charité University Medical Center
  More Information

No publications provided

Responsible Party: Charité - Universitätsmedizin Berlin ( Stefan N Willich, MD, MPH, MBA )
Study ID Numbers: 008
Study First Received: March 19, 2009
Last Updated: March 19, 2009
ClinicalTrials.gov Identifier: NCT00866398     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
coronary heart disease
chd
stent

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on August 25, 2009