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.

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. - The COMPARE II trial

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35434

Enrollment

2000

Registered

2008-12-18

Start date

2009-01-12

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

outcome PCI treatment with stents

Interventions

None listed

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 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)

Design outcomes

Primary

Measure	Time frame
The primary end point of the study is the composite of safety (cardiac death, non fatal myocardial infarction) and efficacy (target vessel revascularization) at 12 months.	—

Secondary

Measure	Time 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 12 months follow-up. B) Incidence of Cardiac Death and Post-Procedural (>48h) MI rate at 12 months, 3 and 5 years C) Target lesion revascularization at 12 months, 3 and 5 years D) The combined endpoint of cardiac death, non fatal myocardial infarction, target vessel revascularization (TVR) rate at 3 and 5 years follow-up. E) The combined endpoint of cardiac death, non fatal myocardial infarction and target vessel revascularization at 12 months, 3 and 5 years in STEMI patients, small vessels ( 20 mm), Female patients, DM patients and octogenarians. F) Procedural performance at the index procedures, measured by the ability to cross the lesions with the designated DES stent. G) Incidence of definite and probable stent thrombosis at 12 months, 3 and 5 years time. H) Incidence of definite, probable and possible stent thrombosis at 12 months, 3 and 5 years time.	—

Measure

Time 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 12 months follow-up. B) Incidence of Cardiac Death and Post-Procedural (>48h) MI rate at 12 months, 3 and 5 years C) Target lesion revascularization at 12 months, 3 and 5 years D) The combined endpoint of cardiac death, non fatal myocardial infarction, target vessel revascularization (TVR) rate at 3 and 5 years follow-up. E) The combined endpoint of cardiac death, non fatal myocardial infarction and target vessel revascularization at 12 months, 3 and 5 years in STEMI patients, small vessels ( 20 mm), Female patients, DM patients and octogenarians. F) Procedural performance at the index procedures, measured by the ability to cross the lesions with the designated DES stent. G) Incidence of definite and probable stent thrombosis at 12 months, 3 and 5 years time. H) Incidence of definite, probable and possible stent thrombosis at 12 months, 3 and 5 years time.

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Countries

Netherlands

Outcome results