Trial Outcomes & Findings for Image Quality and Radiation Dose in Angiography (NCT NCT01381952)

NCT ID: NCT01381952

Last Updated: 2014-05-22

Results Overview

The images were evaluated in randomized, blinded, offline readings. The anonymized images were displayed in pairs, i.e. the reference image run on one monitor (randomly left or right side) with the corresponding quarter-dose image run on the adjacent monitor. Three neuroradiologists graded the arterial, capillary, and venous phases separately. For each characteristic the images quality (IQ) were rated on a scale of 1 to 5 as 1 (very poor), 2 (mediocre), 3 (average), 4 (good), 5 (very good/excellent). An overall IQ score (3-15) was calculated as the sum of the score for these characteristics. A paired Student's t test is used to compare the overall IQ score between the 2 imaging techniques. If the upper limit of the 97.5% one-sided CI for the difference overall IQ between the two treatment groups does not exceed the pre-defined non-inferiority margin of 2.5 Clarity will be declared non-inferior to the current image acquisition settings for DSA.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2014-05-22

Participant Flow

The enrollment of patients occurred between 22 June 2011 and 11 August 2011

20 patients enrolled the study; 16 patients were undergoing diagnostic neuroangiography and 4 were undergoing INR procedures for different pathological conditions. All signed patient consent.

Participant milestones

Measure	AlluraXper - ClarityIQ Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
Overall Study STARTED	20
Overall Study Collected Dose and Image Information	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Image Quality and Radiation Dose in Angiography

Baseline characteristics by cohort

Measure	AlluraXper - ClarityIQ n=20 Participants Angiogram with AlluraXper followed by angiogram with ClarityIQ
Age, Continuous	56 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment Sweden	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

The images were evaluated in randomized, blinded, offline readings. The anonymized images were displayed in pairs, i.e. the reference image run on one monitor (randomly left or right side) with the corresponding quarter-dose image run on the adjacent monitor. Three neuroradiologists graded the arterial, capillary, and venous phases separately. For each characteristic the images quality (IQ) were rated on a scale of 1 to 5 as 1 (very poor), 2 (mediocre), 3 (average), 4 (good), 5 (very good/excellent). An overall IQ score (3-15) was calculated as the sum of the score for these characteristics.

A paired Student's t test is used to compare the overall IQ score between the 2 imaging techniques. If the upper limit of the 97.5% one-sided CI for the difference overall IQ between the two treatment groups does not exceed the pre-defined non-inferiority margin of 2.5 Clarity will be declared non-inferior to the current image acquisition settings for DSA.

Outcome measures

Measure	AlluraXper n=20 Participants Angiogram with AlluraXper followed by angiogram with ClarityIQ	Allura Clarity n=20 Participants Angiogram with AlluraXper followed by angiogram with ClarityIQ
Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated. Investigator 1	9.4 Scores on a scale Interval 8.99 to 9.81	11.9 Scores on a scale Interval 11.33 to 12.42
Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated. Investigator 2	13.1 Scores on a scale Interval 12.75 to 13.45	14.1 Scores on a scale Interval 13.75 to 14.42
Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated. Investigator 3	11.1 Scores on a scale Interval 10.59 to 11.66	12.1 Scores on a scale Interval 11.42 to 12.68

SECONDARY outcome

Timeframe: Participants were followed for the duration of the procedure

Population: All patients with recorded dose information and images for both angiograms were included (n=20)

Percentage of dose reduction of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame.

Outcome measures

Measure	AlluraXper n=20 Participants Angiogram with AlluraXper followed by angiogram with ClarityIQ	Allura Clarity Angiogram with AlluraXper followed by angiogram with ClarityIQ
Radiation Dose Measurements: Dose Area Product (DAP)	72.4 percentage of dose reduction Standard Deviation 1.95 • Interval 71.5 to 73.3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants were followed for the duration of the procedure

Population: All patients with recorded dose information and images for both angiograms were included (n=20)

Percentage of dose reduction of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame.

Outcome measures

Measure	AlluraXper n=20 Participants Angiogram with AlluraXper followed by angiogram with ClarityIQ	Allura Clarity Angiogram with AlluraXper followed by angiogram with ClarityIQ
Radiation Dose Measurements: Air Kerma (AK)	74.6 percentage of dose reduction Standard Deviation 0.9	—

Adverse Events

AlluraXper - 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

Dr. Söderman

Karolinska University Hospital

Phone: +46851774037

Email: michael.soderman@karolinska.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60