Status:
UNKNOWN
Comparison of the Everolimus Eluting With the Biolimus A9 Eluting Stent
Lead Sponsor:
Maasstad Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a prospective, randomized, multi center study. Approximately 2700 patients will be entered in the study and will be randomized on a 2:1 basis. Patients who meet the eligibility criteria will b...
Detailed Description
The main objective of the study is a head to head comparison of the everolimus eluting XIENCE-V ®, XIENCE-Prime® or PROMUS ® stent with the biolimus A9 eluting NOBORI® stent in order to observe whethe...
Eligibility Criteria
Inclusion
- The patient is at least 18 years old and has a life expectancy of 5 years.
- Patient undergoes a PCI procedure for indications according to the Dutch and European guidelines
- Patient is willing to comply with the extended follow-up period of 2 to 5 years(for secondary endpoint only)
- Reference lumen diameter of the treated vessels between 2.0 - 4.0 mm.
- Informed consent
Exclusion
- Expected non-adherence to dual antiplatelet therapy for 1 year (e.g: known allergy to ASA or thienopyridines like clopidogrel)
- Expected major surgery within 30 days (these patients will receive bare metal stents)
- Cardiogenic shock (Kilip class 4)
- Previous PCI procedures with implantation of drug eluting stents within 1 year.
- Expected loss for follow up
- Enrollment in an investigative stent study with different stents
- Inability to implant Nobori or Xience-V / Promus stent(s)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
2700 Patients enrolled
Trial Details
Trial ID
NCT01233453
Start Date
January 1 2009
End Date
December 1 2015
Last Update
January 30 2014
Active Locations (11)
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1
Onassis cardiac Surgery Centre
Athens, Greece
2
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
3
Amphia Ziekenhuis
Breda, Netherlands
4
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands