To show a reduction of contrast use and other procedural features such as radiation exposure, time to cross the culprit lesion with the wire and procedural time with an equivalent or better procedural success and complication rate.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the total contrast used.
Secondary outcome
Secondary endpoints will be
1. the contrast needed to cross the lesion,
2. the time needed to cross the lesion,
3. the total procedural time,
4. the total irradiation,
5. angiographic success rates, and
6. complications.
Background summary
Magnetic steering of an angioplasty wire is a new, method to steer an wire
across a lesion as a part of a percutaneous coronary intervention. This is
more precise and may therefore reduce the patient contrast use, radiation
exposure and procedure time.
Features that may help reduce procedural features.
1. More precise steering of the wire with a system that has the 3 dimensional
vectors to orientate the wire in the coronary artery. This may reduce the
contrast usage and time needed to cross the lesion.
2. The ability to produce a 3D reconstruction from diagnostic angiography films
and therefore reduce a). the need for giving contrast to visualize the vessel
and b). the time taken for the initial preparation.
3. The ability of the system to place a white-line overlay directly on the
fluoroscopy screen that orientates automatically with the x-ray view being
taken, that acts as a map to show the wire position, and particularly
deviations from the correct direction.
The registry of magnetic procedures performed at the OLVG compared to
conventional procedures in the same time period suggests a decrease in the
contrast used without strict adherence to the 3 features described above.
Study objective
To show a reduction of contrast use and other procedural features such as
radiation exposure, time to cross the culprit lesion with the wire and
procedural time with an equivalent or better procedural success and
complication rate.
Study design
This is a prospective, open study with patients randomised in a 1:1 ratio to
use of conventional (manual) manipulation of a standard wire versus the use of
a magnetically navigable wire. The procedures will otherwise follow standard
methods of percutaneous coronary intervention.
Intervention
Magnetic navigation versus conventional procedure during percutaneous coronary
intervention.
Study burden and risks
Participation in the trial will not give any extra risk to the patient. The
expected contrast reduction and reduction in procedural times are associated
with a lower complication rates.
Oosterpark 9
1091 AC Amsterdam
NL
Oosterpark 9
1091 AC Amsterdam
NL
Listed location countries
Age
Inclusion criteria
§ Age>18 years
§ Elective presentation for PCI
§ Diagnostic coronary angiography films suitable for 3D reconstruction
Exclusion criteria
Acute coronary syndromes (unstable angina, MI) and chronic total occlusions
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT01276808 |
| CCMO | NL17838.100.10 |