Het Siemens INNOVANCE* PFA P2Y Test Cartridge Project

Het Siemens INNOVANCE* PFA P2Y Test Cartridge Project - Het Siemens INNOVANCE* PFA P2Y Test Cartridge Project

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34661

Enrollment

100

Registered

2010-07-01

Start date

2010-09-27

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Coronary artery disease - atherosclerosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: •>=18 years of age (18 to 90) •Documented history of vascular disease •Eligible to receive clopidogrel •Indication for clopidogrel (scheduled coronary intervention with stent implantation) • scheduled for elective coronary stent implantation •Able to provide written, informed consent in accordance with the IRB (internal review board or ethics committee) and agree to comply with all protocol-specified procedures

Exclusion criteria

Exclusion criteria: •

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints 1) The magnitude of baseline (or intrinsic) platelet reactivity (reflected by the closure time) among patients who are scheduled for PCI as measured with the INNOVANCE® PFA P2Y 2) The magnitude of on-clopidogrel platelet reactivity (reflected by the closure time) among patients who are scheduled for PCI as measured with the INNOVANCE® PFA P2Y	—

Secondary

Measure	Time frame
1) The magnitude of baseline (or intrinsic) platelet reactivity (among patients who are scheduled for PCI as measured with LTA, WBA and VASP 2) The magnitude of on-clopidogrel platelet reactivity among patients who are scheduled for PCI as measured with LTA, WBA and VASP	—

Countries

Netherlands

Outcome results