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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
  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 "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 Intervention Phase
Coronary Artery Disease
Device: bare metal stent
Device: Cypher-Stent (Implantation of a sirolimus-eluting stent)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Official Title: Model Project for the Reduction of Coronary Restenosis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • MACE (re-PCI, myocardial infarction, CABG, death) [ Time Frame: 3,6,12,24,36 months after stent implantation ] [ Designated as safety issue: No ]

Enrollment: 958
Study Start Date: April 2003
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
BMS
Implantation of a bare metal stent
Device: bare metal stent
implantation of a bare metal stent
SES
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627900

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

Additional Information:
Publications:
Responsible Party: Frau Jena Benkenstein, Techniker Krankenkasse
ClinicalTrials.gov Identifier: NCT00627900     History of Changes
Other Study ID Numbers: EK-Vorgang: Verschiedenes
Study First Received: February 24, 2008
Last Updated: February 24, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
drug-eluting stents

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Coronary Restenosis
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Stenosis
Heart Diseases
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014