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Clinical evaluation of Alpine® vs. Xpedition® stent delivery system of the XIENCE® everolimus-eluting stent

Clinical evaluation of Alpine® vs. Xpedition® stent delivery system of the XIENCE® everolimus-eluting stent - AXES

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45629
Enrollment
500
Registered
2017-07-26
Start date
2017-10-05
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

obstruction in the arteries that supply the heart with blood significant coronary stenosis

Interventions

The first group will undergo PCI with the XIENCE EES using the Alpine stent delivery system, the second group will undergo PCI with the Xpedition stent delivery system.
percutaneous coronary intervention
procedural time
stent delivery system

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: All patients undergoing PCI with EES, aged 18 years or older, will be considered for eligibility.

Exclusion criteria

Exclusion criteria: Patients will be excluded when scheduled for chronic total occlusion (CTO) PCI or if verbal informed consent cannot be obtained.

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the proportion of procedures with crossing time (from introduction of guidewire to stent deployment) longer than 30 minutes.

Secondary

MeasureTime frame
Secondary endpoints include procedural time (from heparin administration to removal of catheter sheath, mins), use of additional materials, total procedural costs, radiation dose (*Gym2), radiation time (mins), and contrast dose (ml).

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)