X-ray Dose Reduction Study for Endovascular Interventional Radiology

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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X-ray dose and image quality are related by laws of physics. Low dose and high image quality cannot be achieved at the same time. However, image processing algorithms can help an x-ray system to acquire images with lower dose without influencing image quality or achieving higher image quality with equal dose. The primary aim of this study is to verify if the diagnostic image quality is equal or better when using a significant reduction in X-ray dose for endovascular digital subtraction angiography in combination with a novel imaging technology compared to using normal dose with conventional image technology.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ClarityIQ

Low-dose DSA (83% reducation compared to normal dose) with novel X-ray imaging technology.

Group Type EXPERIMENTAL

Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology.

Intervention Type RADIATION

Digital Subtraction Angiography (DSA) of iliac artery with reduced dose settings (83% dose reduction expected) in combination with novel X-ray imaging technology.

AlluraXper

Normal dose DSA with conventional X-ray imaging technology.

Group Type ACTIVE_COMPARATOR

Normal dose DSA with conventional X-ray imaging technology

Intervention Type RADIATION

Digital Subtraction Angiography (DSA) of iliac artery with normal dose settings in combination with conventional X-ray imaging technology.

Interventions

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Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology.

Digital Subtraction Angiography (DSA) of iliac artery with reduced dose settings (83% dose reduction expected) in combination with novel X-ray imaging technology.

Intervention Type RADIATION

Normal dose DSA with conventional X-ray imaging technology

Digital Subtraction Angiography (DSA) of iliac artery with normal dose settings in combination with conventional X-ray imaging technology.

Intervention Type RADIATION

Other Intervention Names

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ClarityIQ AlluraXper

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No