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

February 24, 2008 updated by: Charite University, Berlin, Germany

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

958

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10098
        • Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: BMS
Implantation of a bare metal stent
Device: bare metal stent
implantation of a bare metal stent
Other: SES
Implantation of a sirolimus-eluting stent
Device: Cypher-Stent (Implantation of a sirolimus-eluting stent)
Implantation of a sirolimus-eluting stent
Other Names:
  • Cypher-Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cost equivalence of sirolimus-eluting coronary stents versus bare metal stents
Time Frame: 3,6,12,18,24, 36 months following stent implantation
3,6,12,18,24, 36 months following stent implantation

Secondary Outcome Measures

Outcome Measure
Time Frame
MACE (re-PCI, myocardial infarction, CABG, death)
Time Frame: 3,6,12,24,36 months after stent implantation
3,6,12,24,36 months after stent implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Techniker Krankenkasse

Investigators

  • Study Director: Stefan N Willich, MD, MPH, MBA, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Anticipated)

September 1, 2008

Study Registration Dates

First Submitted

February 24, 2008

First Submitted That Met QC Criteria

February 24, 2008

First Posted (Estimate)

March 4, 2008

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

February 24, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-Vorgang: Verschiedenes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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