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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00627900
Recruitment Status : Completed
First Posted : March 4, 2008
Last Update Posted : March 4, 2008
Techniker Krankenkasse
Information provided by:
Charite University, Berlin, Germany

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 "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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: bare metal stent Device: Cypher-Stent (Implantation of a sirolimus-eluting stent) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 958 participants
Allocation: Non-Randomized
Official Title: Model Project for the Reduction of Coronary Restenosis
Study Start Date : April 2003
Estimated Primary Completion Date : September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Implantation of a bare metal stent
Device: bare metal stent
implantation of a bare metal stent

Implantation of a sirolimus-eluting stent
Device: Cypher-Stent (Implantation of a sirolimus-eluting stent)
Implantation of a sirolimus-eluting stent
Other Name: Cypher-Stent

Primary Outcome Measures :
  1. Cost equivalence of sirolimus-eluting coronary stents versus bare metal stents [ Time Frame: 3,6,12,18,24, 36 months following stent implantation ]

Secondary Outcome Measures :
  1. MACE (re-PCI, myocardial infarction, CABG, death) [ Time Frame: 3,6,12,24,36 months after stent implantation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00627900

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Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie
Berlin, Germany, 10098
Sponsors and Collaborators
Charite University, Berlin, Germany
Techniker Krankenkasse
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Study Director: Stefan N Willich, MD, MPH, MBA Charite University, Berlin, Germany

Publications of Results:
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Responsible Party: Frau Jena Benkenstein, Techniker Krankenkasse Identifier: NCT00627900    
Other Study ID Numbers: EK-Vorgang: Verschiedenes
First Posted: March 4, 2008    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: February 2008
Keywords provided by Charite University, Berlin, Germany:
drug-eluting stents
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Restenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs