Trial of Drug Eluting Stent Versus Bare Metal Stent to Treat Coronary Artery Stenosis (NORSTENT)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00811772 |
Recruitment Status :
Completed
First Posted : December 19, 2008
Last Update Posted : December 24, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

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 |

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) |
- First occurrence of all-cause mortality and non-fatal myocardial infarction (composite) [ Time Frame: After five years of follow-up ]
- Major cardiovascular events [ Time Frame: After five years of follow-up ]
- Health related quality of life [ Time Frame: After 6 months and then yearly for 5 years ]

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, Learn About Clinical Studies.
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)

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
Norway | |
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 |
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 |
Other Publications:
Responsible Party: | University of Tromso |
ClinicalTrials.gov Identifier: | NCT00811772 |
Other Study ID Numbers: |
184916/V50 Res. council Norway NSD19480 PREKNORD40/2008 |
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 |
Randomized controlled trial Bare metal stent Drug eluting stent |
Myocardial Infarction Atherosclerosis Angina Pectoris Coronary Artery Disease Myocardial Ischemia Infarction Ischemia Pathologic Processes Necrosis |
Heart Diseases Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Chest Pain Pain Neurologic Manifestations Coronary Disease |