NCT00627900

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
958

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Last Updated

March 4, 2008

Status Verified

February 1, 2008

Enrollment Period

5.4 years

First QC Date

February 24, 2008

Last Update Submit

February 24, 2008

Conditions

Coronary Artery Disease

Keywords

drug-eluting stents

Outcome Measures

Primary Outcomes (1)

  • Cost equivalence of sirolimus-eluting coronary stents versus bare metal stents

    3,6,12,18,24, 36 months following stent implantation

Secondary Outcomes (1)

  • MACE (re-PCI, myocardial infarction, CABG, death)

    3,6,12,24,36 months after stent implantation

Study Arms (2)

BMS

OTHER

Implantation of a bare metal stent

Device: bare metal stent

SES

OTHER

Implantation of a sirolimus-eluting stent

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

Interventions

bare metal stentDEVICE

implantation of a bare metal stent

BMS
Cypher-Stent (Implantation of a sirolimus-eluting stent)DEVICE

Implantation of a sirolimus-eluting stent

Also known as: Cypher-Stent
SES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie

Berlin, 10098, Germany

Location

Related Publications (1)

  • Bruggenjurgen 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. doi: 10.1007/s00059-007-3048-2.

    PMID: 18060612RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Stefan N Willich, MD, MPH, MBA

    Charite University, Berlin, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2008

First Posted

March 4, 2008

Study Start

April 1, 2003

Primary Completion

September 1, 2008

Last Updated

March 4, 2008

Record last verified: 2008-02

Locations

DE(1)