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Comparison of the everolimus eluting XIENCE-V* stent with the paclitaxel eluting TAXUS* stent in all-comers: a randomized open label study.

Comparison of the everolimus eluting XIENCE-V* stent with the paclitaxel eluting TAXUS* stent in all-comers: a randomized open label study. - MCRZ-COMPARE

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON35195
Enrollment
1600
Registered
2007-02-01
Start date
2007-02-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

outcome PCI treatment

Interventions

None listed

Sponsors

Medisch Centrum Rijnmond-Zuid
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients referred for PCI according to dutch and european guidelines Age between 18-85 years

Exclusion criteria

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 Expected loss for follow up 4 Enrollment in another stent study with different stents 5 Inability to implant Taxus or Xience-V stent(s)

Design outcomes

Primary

MeasureTime frame
The primary end point of the study is the composite end point of: all death, non fatal myocardial infarction, target vessel revascularization at 1 year.

Secondary

MeasureTime frame
The secondary end points of the study are: A) The combined endpoint of cardiac death, non fatal myocardial infarction, ischemic driven target lesion revascularization (TLR) rate at 1, 6 and 12 months follow-up. B) The combined endpoint of all death, non fatal myocardial infarction, target vessel revascularization (TVR) rate at 2, 3, 4 and 5 years.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)