X-ray Dose Reduction Study for Endovascular Interventional Radiology

NCT01599741 | Completed Results

• 1 other identifier: XCY607-100093
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Cardiovascular Disease

Keywords

X-rays; Endovascular angiography; Image processing

Outcome Measures

Primary Outcomes (1)

• 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.

  1 Day

Secondary Outcomes (2)

• Radiation Dose Measurements: Dose Area Product (DAP)

  Participants were followed for the duration of the procedure

• Radiation Dose Measurements: Air Kerma (AK)

  Participants were followed for the duration of the procedure

Study Arms (2)

ClarityIQ

EXPERIMENTAL

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

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.

Radiation: Normal dose DSA with conventional X-ray imaging technology

Interventions

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

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

Also known as: ClarityIQ

ClarityIQ

Normal dose DSA with conventional X-ray imaging technology RADIATION

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

Also known as: AlluraXper

AlluraXper

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years of age undergoing digital subtraction angiography for diagnosis or treatment of iliac artery disease.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

St. Antonius Ziekenhuis

Nieuwegein, 3430 EM, Netherlands

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Thijs Grunhagen
• Organization: Philips

thijs.grunhagen@philips.com

+31 6 11645166

Study Officials

• Marco van Strijen, MD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 16, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: March 8, 2022
• Results First Posted: March 5, 2014

Record last verified: 2022-03

Locations

NL (1)