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

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ClinicalTrials.gov Identifier: NCT00811772
Recruitment Status : Completed
First Posted : December 19, 2008
Last Update Posted : December 24, 2018
The Research Council of Norway
The Royal Norwegian Ministry of Health
Norwegian Council on Cardiovascular diseases
Information provided by (Responsible Party):
University of Tromso

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Atherosclerosis Angina Pectoris Myocardial Infarction Device: Percutaneous coronary intervention (PCI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9013 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Long-term Effects on Mortality and Cardiovascular Morbidity of Percutaneous Coronary Intervention With Drug-eluting Stent Versus Bare-metal Stent. Randomized, Five-year Prospective, Multicenter Clinical Trial
Actual Study Start Date : September 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Bare metal stent
Implantation of one or more bare metal stent(s) to to treat coronary artery stenosis
Device: Percutaneous coronary intervention (PCI)
Implantation of one or more bare metal stent(s)

Experimental: Drug eluting stent
Implantation of one or more drug eluting stent(s) to treat coronary artery stenosis
Device: Percutaneous coronary intervention (PCI)
Implantation of one or more drug eluting stent(s)

Primary Outcome Measures :
  1. First occurrence of all-cause mortality and non-fatal myocardial infarction (composite) [ Time Frame: After five years of follow-up ]

Secondary Outcome Measures :
  1. Major cardiovascular events [ Time Frame: After five years of follow-up ]
  2. Health related quality of life [ Time Frame: After 6 months and then yearly for 5 years ]

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women >18 years with stable angina pectoris or acute coronary syndrome
  • The patient has consented to participate and has signed the patient informed consent form
  • All lesions requiring intervention in one or more native coronary artery/coronary artery by-pass graft are amendable for implantation of drug-eluting stents only, or bare-metal stents only.
  • The patient has a unique 11-digit Norwegian person number, is able to communicate in Norwegian, and is expected not to emigrate during study follow-up.

Exclusion Criteria:

  • Previous implantation of a coronary bare metal stent or coronary drug eluting stent
  • Planned intervention of a bifurcation lesion with overlapping 2-stent technique
  • The patient has a serious medical condition (other than coronary artery disease) with a life expectancy less than 5 years
  • The patient is currently participating in another randomized trial that clinically interferes with the present trial, or requires coronary angiography or other coronary artery imaging procedures
  • Hypersensitivity or allergies to drugs or components in use with percutaneous coronary intervention
  • Contraindications for treatment with clopidogrel/ticlid for 9-12 months
  • Patient is receiving chronic anticoagulation therapy (e.g., warfarin, heparin)

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 ClinicalTrials.gov identifier (NCT number): NCT00811772

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Department of Medicine, Sørlandet sykehus Arendal
Arendal, Norway, N-4838
Department of Heart Disease, Haukeland University Hospital
Bergen, Norway, N-5053 Bergen
Department of Heart Disease, Feiringklinikken AS
Feiring, Norway, N-2093
Department of Heart Disease, Rikshospitalet HF
Oslo, Norway, N-0027
Department of Heart and Vascular Radiology and Department of Heart Disease, Ullevål University Hospital
Oslo, Norway, N-0450
Department of Heart Disease, Stavanger University Hospital
Stavanger, Norway, N-4068
Department of Heart Disease, University Hospital of Northern Norway
Tromsø, Norway, N-9038
Department of Heart Disease, St.Olav University Hospital
Trondheim, Norway, N-7006
Sponsors and Collaborators
University of Tromso
The Research Council of Norway
The Royal Norwegian Ministry of Health
Norwegian Council on Cardiovascular diseases
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Principal Investigator: 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
Study Chair: Jan E Nordrehaug, MD, PhD Department of Heart Disease, Haukeland University Hospital, Bergen, and University of Bergen, Bergen, Norway
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT00811772    
Other Study ID Numbers: 184916/V50 Res. council Norway
First Posted: December 19, 2008    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Tromso:
Randomized controlled trial
Bare metal stent
Drug eluting stent
Additional relevant MeSH terms:
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Myocardial Infarction
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Chest Pain
Neurologic Manifestations
Coronary Disease