Compare the stability of the FFR measurement and the handling performance of the St. Jude Pressure Wire X compared to the Opsens OptoWire Deux.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Fractional Flow Reserve (FFR) is an index that is used to determine the
functional significance of coronary artery disease (CAD) during cardiac
catheterization. FFR requires measurement of aortic and distal coronary
pressure. The latter is usually determined by a pressure sensor mounted guide
wire. The challenge with current pressure guidewires is that they measure
pressure using piezo-resistive pressure sensors that are sensitive to moisture
which influences the stability of the transmitted pressure signal. Potentially,
unreliable measurements with consequent erroneous clinical decisions could be
made. Moreover, wire handling with these pressure mounted guide wires is
different from regular guidewires due to the design. This fact limits adoption
of functional assessment of CAD in the cathlab. Therefore, there is a clinical
need for a FFR wire providing reliable pressure measurement and whose
performance would be closer to standard angioplasty-wire.
Study objective
Compare the stability of the FFR measurement and the handling performance of
the St. Jude Pressure Wire X compared to the Opsens OptoWire Deux.
Study design
Observational study, two-center, two-arm study
Study burden and risks
In this study the small additional small risk arises from the elongation of the
procedure due to the repetition of the FFR measurement. FFR measurement is
standard of care and has a Class 1A recommendation for lesion assessment
pre-percutaneous coronary intervention in the European Society of Cardiology
guidelines for revascularization. The risks of a FFR measurement are small in
experienced hands and almost always temporary. There is no direct benefit for
the patient when participating in this study.
Henri Dunantstraat 1
's Hertogenbosch 5223 GZ
NL
Henri Dunantstraat 1
's Hertogenbosch 5223 GZ
NL
Listed location countries
Age
Inclusion criteria
Patients with at least one lesion indicated for FFR
Exclusion criteria
More than 3 lesions indicated for FFR measurements
Type C lesions
Lesions with angiographic 'haziness' or suspected to contain thrombus
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60721.028.17 |