The objective of the study is to assess image quality and diagnostic information in iliac angiography with a lower exposure dose.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Simultaneous visual comparison of image quality in the two groups, by blinded
reviewers. Image quality is assesed by following a specific test protocol
regarding vessel visibility.
Secondary outcome
N/A
Background summary
The increasingly complex nature of many endovascular interventions requires the
use of significant amounts of radiation for their completion. However,
procedures performed under fluoroscopy lead to an increased risk of radiation
damage to tissues. Unnecessary exposure to any form of ionizing radiation
should therefore be avoided. The reduction of radiation exposure is of
particular importance in the pelvic area, since the reproductive organs of
patients are either in the primary beam or in close proximity to it. This means
that the radiation risk to the patient and future generations is much higher
compared to examinations in which the gonads are farther from the primary beam.
Hence, radiation dose during pelvic X-ray examinations needs to be investigated
in order to reduce the radiation exposure. Any meaningful investigation of
possible dose reductions must be conducted in conjunction with image quality
measurements.
Study objective
The objective of the study is to assess image quality and diagnostic
information in iliac angiography with a lower exposure dose.
Study design
Study design: patient-controlled
Masking: randomized, blinded review
Primary Purpose: Diagnostic
Study burden and risks
When exposed to high intensities, or for a long time. X-rays can be harmful.
Contrast agent can damage kidneys when used in large quantities.The burden to
the patient consists of an additional contrast injection under X-ray guidance.
This will prolonge the total procedure with 1,5 minute. The radiation exposure
during the additional contrast injection will be limited, as a low-dose
protocol will be used. Additional radiation exposure to the patient will only
occur if the image quality of the low-dose protocol proves insufficient, and
the procedure thus needs to be finished with the standard dose. If the
additional series with the low dose protocol proves to be of suffiecient
quality, the procedure will be completed with that low dose settings. The total
radiation dose during the procedure will then be significantly lower than with
the standard treatment.
Veenpluis 4-6
5680 DA Best
NL
Veenpluis 4-6
5680 DA Best
NL
Listed location countries
Age
Inclusion criteria
Patients older than 18 years of age undergoing iliac artery angiography
Exclusion criteria
- Patients not willing or unable to give consent to participate
- Patients already involved in a clinical trial
- Patients under the age of 18
- Pregnant or breastfeeding women
- Patients with kidney disease (eGFR < 60)
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 |
|---|---|
| Other | het registratieproces is ingezet; het identificatienummer zal worden overlegd zodra deze bekend is en voordat de eerste patient zal worden geincludeerd |
| CCMO | NL39423.100.12 |