Image Quality and Radiation Dose in Angiography

Not Applicable

Completed

Conditions: Aneurysm
Arteriovenous Malformations
Stenosis
Dural Arteriovenous Malformations

Interventions: Radiation: Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology.
Radiation: Normal dose DSA with conventional X-ray technology

Brief Summary: ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly. This is realized by anatomy-specific optimization of the full acquisition chain (grid switch, beam filtering, pulse width, spot size, detector and image processing engine) for every clinical task individually. Furthermore, smaller focal spot sizes and shorter pulses are used, which are known to positively influence image quality . The final effect on the clinical image quality is investigated in this study.

Detailed Description: The advent of interventional neuroradiology (INR) has changed the treatment of neurovascular diseases by reducing the procedural invasiveness and the recovery time needed by patients, thus improving clinical outcome. However, INR procedures often require many high-quality digital substraction angiography (DSA) runs and long total fluoroscopy times, which can result in patients being exposed to considerable radiation doses levels.

In order to introduce a dose reduction technology the most important aspect is to validate the diagnostic image information. Philips has developed a real-time noise reduction algorithm for DSA in neuroradiology that is capable to reduce the patient entrance dose by 75% without loss of image quality.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Reduced radiation dose (ClarityIQ)	Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology.	Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology
Normal radiation dose (AlluraXper)	Normal dose DSA with conventional X-ray technology	Normal dose DSA with conventional X-ray technology.

Primary Outcome Measures

Name	Time	Method
Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated.	1 day	The images were evaluated in randomized, blinded, offline readings. The anonymized images were displayed in pairs, i.e. the reference image run on one monitor (randomly left or right side) with the corresponding quarter-dose image run on the adjacent monitor. Three neuroradiologists graded the arterial, capillary, and venous phases separately. For each characteristic the images quality (IQ) were rated on a scale of 1 to 5 as 1 (very poor), 2 (mediocre), 3 (average), 4 (good), 5 (very good/excellent). An overall IQ score (3-15) was calculated as the sum of the score for these characteristics. A paired Student's t test is used to compare the overall IQ score between the 2 imaging techniques. If the upper limit of the 97.5% one-sided CI for the difference overall IQ between the two treatment groups does not exceed the pre-defined non-inferiority margin of 2.5 Clarity will be declared non-inferior to the current image acquisition settings for DSA.

Secondary Outcome Measures

Name	Time	Method
Radiation Dose Measurements: Dose Area Product (DAP)	Participants were followed for the duration of the procedure	Percentage of dose reduction of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame.