Comparison of the everolimus eluting (XIENCE-V*/XIENCE-PRIME* or PROMUS* stent) with the biolimus A9 eluting NOBORI* stent in all-comers: a randomized open label study.
Phase 4
Recruiting
- Conditions
- outcome PCI treatment with stents10011082
- Registration Number
- NL-OMON35434
- Lead Sponsor
- Overige Ziekenhuizen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2000
Inclusion Criteria
All patients referred for PCI according to dutch and european guidelines
Age between 18-85 years
Exclusion Criteria
1 Expected non-adherence to dual antiplatelet therapy for 1 year (e.g: known allergy to ASA or thienopyridines like clopidogrel)
2 Expected major surgery within 30 days (these patients will receive bare metal stents)
3 Cardiogenic shock (Kilip class 4)
4 Previous PCI procedures with implantation of drug eluting stents within 1 year.
5 Expected loss for follow up
6 Enrollment in an investigative stent study with different stents
7 Inability to implant Nobori or Xience-V / Promus stent(s)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary end point of the study is the composite of safety (cardiac death,<br /><br>non fatal myocardial infarction) and efficacy (target vessel revascularization)<br /><br>at 12 months.</p><br>
- Secondary Outcome Measures
Name Time Method