Text Size

Cost-Effectiveness Study in the Reduction of Coronary Restenosis With Sirolimus-Eluting Stents (GERSHWIN)

This study has been completed.
Sponsor:
Collaborator:
Techniker Krankenkasse
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00627900
First received: February 24, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted

February 24, 2008
February 24, 2008
April 2003
September 2008   (final data collection date for primary outcome measure)
Cost equivalence of sirolimus-eluting coronary stents versus bare metal stents [ Time Frame: 3,6,12,18,24, 36 months following stent implantation ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
MACE (re-PCI, myocardial infarction, CABG, death) [ Time Frame: 3,6,12,24,36 months after stent implantation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cost-Effectiveness Study in the Reduction of Coronary Restenosis With Sirolimus-Eluting Stents
Model Project for the Reduction of Coronary Restenosis

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 "Prevention of Coronary Restenosis" examines the effectiveness of sirolimus-eluting stents (SES) 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, re-intervention rate, as well as an account of the utilisation and benefits of the implemented standardised guidelines.

In this prospective, multi-centre, country-wide cohort study, 658 patients undergoing an implantation of a SES for treatment of coronary stenosis were recruited from 35 hospital centres. Their treatment and outcomes will be evaluated over a 3-year period by means of standardised questionnaires. In addition, information obtained from the patients will be confirmed and augmented by telephone interviews with the attending physicians involved in their follow-up care.

In order to appraise the effect of the new therapy, a comparison cohort group of 394 patients receiving a BMS was recruited. These patients will be evaluated and observed by the same method as those patients receiving a drug-eluting stent, also over 3 years
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Coronary Artery Disease
  • Device: bare metal stent
    implantation of a bare metal stent
  • Device: Cypher-Stent (Implantation of a sirolimus-eluting stent)
    Implantation of a sirolimus-eluting stent
    Other Name: Cypher-Stent
  • BMS
    Implantation of a bare metal stent
    Intervention: Device: bare metal stent
  • SES
    Implantation of a sirolimus-eluting stent
    Intervention: Device: Cypher-Stent (Implantation of a sirolimus-eluting stent)
Brüggenjürgen B, McBride D, Bode C, Hamm CW, Kuck KH, Willich SN. Sirolimus-eluting versus bare-metal stents for the reduction of coronary restenosis: 18-month angiographic results from the GERSHWIN Study. Herz. 2007 Dec;32(8):650-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
958
Not Provided
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • indication for implantation of a coronary stent
  • de novo lesions < or = 30 mm in patients with diabetes
  • de novo lesions 12-30 mm or RVD 2.5-3.00 mm in patients without diabetes

Exclusion Criteria:

  • acute MI
  • lesion length >30 mm
  • in-stent restenosis
  • distal lesion in RVD < 2.25 mm
  • lesion in left main or bypass vessel
  • contraindication to Clopidogrel
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00627900
EK-Vorgang: Verschiedenes
No
Frau Jena Benkenstein, Techniker Krankenkasse
Charite University, Berlin, Germany
Techniker Krankenkasse
Study Director: Stefan N Willich, MD, MPH, MBA Charite University, Berlin, Germany
Charite University, Berlin, Germany
February 2008

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