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Trial of Drug Eluting Stent Versus Bare Metal Stent to Treat Coronary Artery Stenosis

NCT00811772 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9013

Last updated 2018-12-24

No results posted yet for this study

Summary

Stenosis of the coronary arteries may be treated by balloon dilatation followed by the implantation of a metal stent. However, restenosis occurs in 10-20% of patients treated with bare metal stents (BMS). Restenosis and treatment of restenosis is associated with risk of myocardial infarction (MI) and death. Drug eluting stents (DES)release drugs to the vessel wall that delay or inhibit the process of restenosis. Some reports have found that DES are associated with risk of acute stent thrombosis, MI and death. The precise magnitude of this risk is not known. Current evidence is therefore insufficient to balance the long-term risk and benefit of BMS vs DES.

The purpose of this trial is to compare the long-term effects on MI and total mortality of BMS vs DES. The trial will recruit 8000 patients from 8 Norwegian hospitals. The patients will be randomized to treatment with BMS or DES. Clinical events will be registered for 5 years after treatment. The study hypothesis is that there is no difference in the risk of death or myocardial infarction after treatment with BMS vs DES. The trial is initiated and run by university researchers and is sponsored by not-for-profit organizations.

Conditions

Interventions

DEVICE

Percutaneous coronary intervention (PCI)

Implantation of one or more bare metal stent(s)

DEVICE

Percutaneous coronary intervention (PCI)

Implantation of one or more drug eluting stent(s)

Sponsors & Collaborators

  • The Research Council of Norway

    collaborator OTHER

  • The Royal Norwegian Ministry of Health

    collaborator OTHER

  • Norwegian Council on Cardiovascular diseases

    collaborator UNKNOWN

  • University of Tromso

    lead OTHER

Principal Investigators

  • Kaare H Bønaa, MD, PhD · Dept of Heart Disease, St.Olavs University Hospital, Trondheim, Norway; Norwegian University of Science and Technology, Trondheim, Norway; University of Tromsø, Tromsø, Norway

  • Jan E Nordrehaug, MD, PhD · Department of Heart Disease, Haukeland University Hospital, Bergen, and University of Bergen, Bergen, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00811772 on ClinicalTrials.gov