Trial Outcomes & Findings for X-ray Dose Reduction Study for Endovascular Interventional Radiology (NCT NCT01599741)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

1 Day

Results posted on

2022-03-08

Participant Flow

The enrollment of patients occured between July 3 and October 12, 2012

Participant milestones

Participant milestones
Measure	Allura-Xper-ClarityIQ DSA acquisition of iliac artery with AlluraXper directly followed by DSA with ClarityIQ
Overall Study STARTED	51
Overall Study Collected Dose and Image Information	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

X-ray Dose Reduction Study for Endovascular Interventional Radiology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Allura-Xper-ClarityIQ n=51 Participants DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ
Age, Continuous	66 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment Netherlands	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

Population: All patients with recorded dose information from the system for both DSA runs were used.

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.

Outcome measures

Outcome measures
Measure	Allura-Xper-ClarityIQ n=48 Participants DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
Image Quality	0.96 Proportion of images rated equal/better Interval 0.93 to 0.98

SECONDARY outcome

Timeframe: Participants were followed for the duration of the procedure

Population: All patients with recorded dose information from the system for both DSA runs were used.

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.

Outcome measures

Outcome measures
Measure	Allura-Xper-ClarityIQ n=48 Participants DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
Radiation Dose Measurements: Dose Area Product (DAP)	-83 percentage of dose change Standard Deviation 5

SECONDARY outcome

Timeframe: Participants were followed for the duration of the procedure

Population: All patients with recorded dose information from the system for both DSA runs were used.

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.

Outcome measures

Outcome measures
Measure	Allura-Xper-ClarityIQ n=48 Participants DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
Radiation Dose Measurements: Air Kerma (AK)	-83 percentage of dose change Standard Deviation 5

Adverse Events

Allura-Xper-ClarityIQ

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thijs Grunhagen

Philips

Phone: +31 6 11645166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60