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N/A N=20 Double-blind Diagnostic

Image Quality and Radiation Dose in Angiography

Arteriovenous Malformations · Aneurysm · Stenosis · Dural Arteriovenous Malformations

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated. — 9.4; 11.9; 13.1; 14.1 Scores on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology. (Radiation); Normal dose DSA with conventional X-ray technology (Radiation)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Karolinska University Hospital
Primary completion
Aug 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated.
9.4; 11.9; 13.1; 14.1; 11.1; 12.1
SECONDARY
Radiation Dose Measurements: Dose Area Product (DAP)
72.4

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.

Eligibility Criteria

Inclusion Criteria

  • Age 18-80
  • Normal kidney function
  • Neurologically intact
  • Planned for diagnostic angiography or endovascular treatment

Exclusion Criteria

  • Pregnancy
  • Other conditions that limit the use of contrast media or ionizing radiation
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01381952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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