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Pressure Guidewire Comparative In Patients Study

Pressure Guidewire Comparative In Patients Study - FFR COMP-IP-02 study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45355
Enrollment
20
Registered
2017-12-21
Start date
2018-03-16
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

Coronary artery disease Intravascular blood pressure

Interventions

Diagnostic angiography
Drift
intravascular blood pressure

Sponsors

Jeroen Bosch Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Patients with at least one lesion indicated for FFR

Exclusion criteria

Exclusion criteria: More than 3 lesions indicated for FFR measurements Type C lesions Lesions with angiographic 'haziness' or suspected to contain thrombus

Design outcomes

Primary

MeasureTime frame
The FFR measurement reliability is assessed by two measures. First reliability is assessed by tracking and recording the drift caused by the pressure guidewire residing within the coronary artery. This is determined by the value of Pd/Pa before and after the procedure when pulled back just outside the guiding catheter. Secondly, FFR reliability is assessed by the stability of Pd/Pa during constant hyperemia.

Secondary

MeasureTime frame
The wire handling performance is assessed by scoring both wires by the same investigator in the same patient. The following characteristics are scored on a 5 point scale: torquability, steerability, pushability and support. The wire performance is also assessed by measuring the time it takes to reach and cross the lesion.

Countries

Belgium, Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)