Cardiovascular DiseaseNCT01599741
X-ray Dose Reduction Study for Endovascular Interventional Radiology
A study testing Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology. and Normal dose DSA with conventional X-ray imaging technology in people with Cardiovascular Disease, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology. and Normal dose DSA with conventional X-ray imaging technology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2012to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years of age undergoing digital subtraction angiography for diagnosis or treatment of iliac artery disease.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation and Evaluation of X-ray Image Processing for Endovascular Digital Subtraction Angiography and Intervention
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.
Read the detailed description
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
- Cardiovascular Disease
- Being tested
- Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology., Normal dose DSA with conventional X-ray imaging technology
- Keywords
- X-rays, Endovascular angiography, Image processing
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology.Radiation
Also called ClarityIQ
Digital Subtraction Angiography (DSA) of iliac artery with reduced dose settings (83% dose reduction expected) in combination with novel X-ray imaging technology.
Normal dose DSA with conventional X-ray imaging technologyRadiation
Also called AlluraXper
Digital Subtraction Angiography (DSA) of iliac artery with normal dose settings in combination with conventional X-ray imaging technology.
| Study group | Role | What they receive |
|---|---|---|
| ClarityIQ | Experimental | Low-dose DSA (83% reducation compared to normal dose) with novel X-ray imaging technology. Receives: Radiation: Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology. |
| AlluraXper | Active comparator | Normal dose DSA with conventional X-ray imaging technology. Receives: Radiation: Normal dose DSA with conventional X-ray imaging technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality
Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded reviewers. Reading is performed by simultaneous visual comparison of image quality of AlluraXper and ClarityIQ by multiple blinded readers. All blinded readers have rated all side-by-side presented images. The images are presented in a random order and blinded to the reader. The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI) is used.
Measured: 1 Day
Secondary outcomes (2)
Radiation Dose Measurements: Dose Area Product (DAP)
Percentage dose change of ClarityIQ vs. AlluraXper in DAP calculated by DAP/frame for DSA. Negative change means a reduction in dose for ClarityIQ vs. AlluraXper.
DAP was measured during the ClarityIQ and AlluraXper runs during the procedure.
Measured: Participants were followed for the duration of the procedure
Radiation Dose Measurements: Air Kerma (AK)
Percentage dose change of ClarityIQ vs. AlluraXper in AK calculated by AK/frame for DSA. Negative change means a reduction in dose for ClarityIQ vs. AlluraXper.
AK was measured during the ClarityIQ and AlluraXper runs during the procedure.
Measured: Participants were followed for the duration of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco van Strijen, MD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599741
- Sponsor's protocol ID
- XCY607-100093
- Status last verified
- Mar 2022
- First submitted
- 8 May 2012
- Last updated
- 8 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation and Evaluation of X-ray Image Processing for Endovascular Digital Subtraction Angiography and Intervention
- ClinicalTrials.gov ID
- NCT01599741
- Acronym / sponsor ID
- XCY607-100093
- Conditions
- Cardiovascular Disease
- Keywords
- X-rays, Endovascular angiography, Image processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Posted 5 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ClarityIQ | Experimental | Radiation: Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology.Low-dose DSA (83% reducation compared to normal dose) with novel X-ray imaging technology. |
| AlluraXper | Active comparator | Radiation: Normal dose DSA with conventional X-ray imaging technologyNormal dose DSA with conventional X-ray imaging technology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18 years of age undergoing digital subtraction angiography for diagnosis or treatment of iliac artery disease.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology.Also: ClarityIQDigital Subtraction Angiography (DSA) of iliac artery with reduced dose settings (83% dose reduction expected) in combination with novel X-ray imaging technology. | Radiation | ClarityIQ |
| Normal dose DSA with conventional X-ray imaging technologyAlso: AlluraXperDigital Subtraction Angiography (DSA) of iliac artery with normal dose settings in combination with conventional X-ray imaging technology. | Radiation | AlluraXper |
Primary outcome
Image Quality
Time frame: 1 Day
Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded reviewers. Reading is performed by simultaneous visual comparison of image quality of AlluraXper and ClarityIQ by multiple blinded readers. All blinded readers have rated all side-by-side presented images. The images are presented in a random order and blinded to the reader. The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI) is used.
2 secondary outcomes
Radiation Dose Measurements: Dose Area Product (DAP)
Time frame: Participants were followed for the duration of the procedure
Radiation Dose Measurements: Air Kerma (AK)
Time frame: Participants were followed for the duration of the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco van Strijen, MD principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology. and Normal dose DSA with conventional X-ray imaging technology in people with Cardiovascular Disease, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Quality (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.