Status:
COMPLETED
Trial of Drug Eluting Stent Versus Bare Metal Stent to Treat Coronary Artery Stenosis
Lead Sponsor:
University of Tromso
Collaborating Sponsors:
The Research Council of Norway
The Royal Norwegian Ministry of Health
Conditions:
Coronary Atherosclerosis
Angina Pectoris
Eligibility:
All Genders
19+ years
Phase:
NA
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 (B...
Detailed Description
Background: The balance of the long-term risks and benefits of coronary drug-eluting stents versus bare metal stents is not known. Study objective: The primary objective of the trial is to compare ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
9013 Patients enrolled
Trial Details
Trial ID
NCT00811772
Start Date
September 1 2008
End Date
December 1 2015
Last Update
December 24 2018
Active Locations (8)
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1
Department of Medicine, Sørlandet sykehus Arendal
Arendal, Norway, N-4838
2
Department of Heart Disease, Haukeland University Hospital
Bergen, Norway, N-5053 Bergen
3
Department of Heart Disease, Feiringklinikken AS
Feiring, Norway, N-2093
4
Department of Heart Disease, Rikshospitalet HF
Oslo, Norway, N-0027