Status:
COMPLETED
SORT-OUT V - Randomised Clinical Comparative Study of the Nobori and the Cypher Stent.
Lead Sponsor:
Aarhus University Hospital Skejby
Collaborating Sponsors:
Terumo Europe N.V.
Johnson & Johnson
Conditions:
Coronary Artery Disease
Angina Pectoris
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
To perform a randomized comparison between the Cypher Select+ stent and the Nobori stent in the treatment of unselected patients with ischaemic heart disease.
Detailed Description
All patients to be treated with one or several drug-eluting coronary stents at one of the four heart centers in Odense, Skejby, Aalborg and Varde can be included in the study. All patients enrolled in...
Eligibility Criteria
Inclusion
- All patients eligible for treatment with one or several drug-eluting coronary stents at one of the four heart centers in Odense, Skejby, Aalborg or Varde can be included in the study.
- The patients will be treated in accordance with the criteria applicable at the individual sites. The indication for using DES varies slightly between the four sites, as the indication for implantation of DES is based on clinical and angiographic criteria with the financial constraints applying at the individual site. Basically, DES will be chosen instead of BMS in patients with an estimated increased risk of restenosis, in patients with the following stenosis types: Long lesions, lesions in small vessels, bifurcations, ostial lesions, in-stent restenoses and stenosis in the proximal segment of the anterior descending branch. Furthermore, DES will also be chosen for diabetics and in the left main.
Exclusion
- The patient does not wish to participate
- The patient is participating in other randomized stent studies
- Life expectancy \< 1 year
- Allergic to Aspirin, clopidogrel, prasugrel or ticlopidin
- Allergic to sirolimus or biolimus
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
2504 Patients enrolled
Trial Details
Trial ID
NCT01254981
Start Date
July 1 2009
End Date
December 1 2011
Last Update
August 29 2013
Active Locations (3)
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1
Aalborg Universitetshospital
Aalborg, Denmark, 9000
2
Aarhus University Hospital, Skejby
Aarhus N, Denmark, 8200
3
Odense University Hospital
Odense, Denmark, 5000