N/A
N=51
X-ray Dose Reduction Study for Endovascular Interventional Radiology
Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT01599741 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Image Quality — 0.96 Proportion of images rated equal/better
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology. (Radiation); Normal dose DSA with conventional X-ray imaging technology (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Philips Clinical & Medical Affairs Global
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Image Quality |
0.96 | — |
| SECONDARY Radiation Dose Measurements: Dose Area Product (DAP) |
-83 | — |
| SECONDARY Radiation Dose Measurements: Air Kerma (AK) |
-83 | — |
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, shorter pulses and the introduction of automatic real-time motion compensation in subtraction imaging are used, which are known to positively influence image quality . The final effect on the clinical image quality in peripheral angiography is investigated in this study.
Eligibility Criteria
Inclusion Criteria
- Patients older than 18 years of age undergoing digital subtraction angiography for diagnosis or treatment of iliac artery disease.
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)
Data sourced from ClinicalTrials.gov (NCT01599741). 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.