Trial Outcomes & Findings for Next Generation X-ray Imaging System (NCT NCT04571099)

Results Overview

Accuracy of dual energy CBCT ASPECTS score to determine the extent and localization of ischemic stroke changes in brain tissue, evaluated by three independent neuroradiologists, using non enhanced CT ASPECTS as reference standard. The Alberta stroke program early CT score (ASPECTS) is a 10-point quantitative topographic CT scan score used for middle cerebral artery (MCA) stroke patients. Segmental estimation of the middle cerebral artery (MCA) vascular territory is made, and 1 point is deducted from the initial score of 10 for every region involved.

Recruitment status

COMPLETED

Target enrollment

28 participants

Primary outcome timeframe

Within 2 days after procedure

Results posted on

2024-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	I - Ischemic Stroke, no Thrombectomy I - Ischemic stroke, no thrombectomy	II - Ischemic Stroke, Thrombectomy II - Ischemic stroke, thrombectomy	III - Hemorrhagic Stroke III - Hemorrhagic stroke
Overall Study STARTED	3	22	3
Overall Study COMPLETED	3	22	3
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	I - Ischemic Stroke, no Thrombectomy n=3 Participants I - Ischemic stroke, no thrombectomy	II - Ischemic Stroke, Thrombectomy n=22 Participants II - Ischemic stroke, thrombectomy	III - Hemorrhagic Stroke n=3 Participants III - Hemorrhagic stroke	Total n=28 Participants Total of all reporting groups
Age, Continuous	69.3 years STANDARD_DEVIATION 9.6 • n=3 Participants	74.5 years STANDARD_DEVIATION 9.7 • n=22 Participants	76.7 years STANDARD_DEVIATION 7.8 • n=3 Participants	74.1 years STANDARD_DEVIATION 9.6 • n=28 Participants
Sex: Female, Male Female	2 Participants n=3 Participants	16 Participants n=22 Participants	0 Participants n=3 Participants	18 Participants n=28 Participants
Sex: Female, Male Male	1 Participants n=3 Participants	6 Participants n=22 Participants	3 Participants n=3 Participants	10 Participants n=28 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	3 participants n=3 Participants	22 participants n=22 Participants	3 participants n=3 Participants	28 participants n=28 Participants
Body Mass Index (BMI)	28.5 kg/m2 STANDARD_DEVIATION 5.7 • n=3 Participants	25.4 kg/m2 STANDARD_DEVIATION 5.1 • n=22 Participants	22.8 kg/m2 STANDARD_DEVIATION 1.0 • n=3 Participants	25.6 kg/m2 STANDARD_DEVIATION 5.2 • n=28 Participants

PRIMARY outcome

Timeframe: Within 2 days after procedure

Population: Each ASPECTS region was assessed individually (affected versus non-affected). Hemorrhagic stroke patients were excluded for this analysis.

Accuracy of dual energy CBCT ASPECTS score to determine the extent and localization of ischemic stroke changes in brain tissue, evaluated by three independent neuroradiologists, using non enhanced CT ASPECTS as reference standard. The Alberta stroke program early CT score (ASPECTS) is a 10-point quantitative topographic CT scan score used for middle cerebral artery (MCA) stroke patients. Segmental estimation of the middle cerebral artery (MCA) vascular territory is made, and 1 point is deducted from the initial score of 10 for every region involved.

Outcome measures

Outcome measures
Measure	I - Ischemic Stroke, no Thrombectomy n=3 Participants I - Ischemic stroke, no thrombectomy	II - Ischemic Stroke, Thrombectomy n=22 Participants II - Ischemic stroke, thrombectomy	III - Hemorrhagic Stroke III - Hemorrhagic stroke
Ischemic Stroke Diagnostic Accuracy (CBCT Versus CT)	90 percentage of gold standard	90 percentage of gold standard	—

SECONDARY outcome

Timeframe: Within 2 days after procedure

Population: Contrast enhanced scans where not collected for Ischemic stroke, no thrombectomy (I) \& Hemorrhagic stroke patients (III), hence where not part of this analysis.

Percentage of images made with new investigational device (dual layer CBCT) rated non-inferior vessel visibility compared to CTA (reference standard). Vessel visibility was evaluated separately as indicators of diagnostic quality on 5-point Likert scales, adopted with slight modifications from previous studies (5: excellent vessel visibility or no artifacts, 1:vessel not visible or extensive artifacts). Sixteen intracranial arterial segments were prospectively defined for the reader study. The score difference between DL-CBCTA and CTA for each segment in each patient determined whether a segment was considered inferior, equal or superior.

Outcome measures

Outcome measures
Measure	I - Ischemic Stroke, no Thrombectomy I - Ischemic stroke, no thrombectomy	II - Ischemic Stroke, Thrombectomy n=21 Participants II - Ischemic stroke, thrombectomy	III - Hemorrhagic Stroke III - Hemorrhagic stroke
Percentage of Dual Layer CBCT Images With Non-inferior Vessel Tree Visibility Compared to CTA (Reference Standard)	—	77 percentage of gold standard	—

SECONDARY outcome

Timeframe: Within 2 days after procedure

Population: The target for hemorrhage detection was set to not miss any bleeding given a limited number of participants. Three primary hemorrhages (III - Hemorrhagic stroke) and five hemorrhagic transformations of ischemic stroke (II - Ischemic stroke, thrombectomy) were detected in the reference CT examinations. Hence, eight matched scans with hemorrhages were included in the analysis (28% of all scans).

Accuracy of images made with new investigational device (dual layer CBCT) to determine the presence of intracranial hemorrhage (Yes/No) using non enhanced CT as the reference standard as judged by the individual reader (neuroradiologist) through blinded reader assessment.

Outcome measures

Outcome measures
Measure	I - Ischemic Stroke, no Thrombectomy I - Ischemic stroke, no thrombectomy	II - Ischemic Stroke, Thrombectomy n=5 Participants II - Ischemic stroke, thrombectomy	III - Hemorrhagic Stroke n=3 Participants III - Hemorrhagic stroke
Intracranial Hemorrhage Detection Accuracy (CBCT With CT as Reference Standard)	—	100 percentage of gold standard	100 percentage of gold standard

Adverse Events

I - Ischemic Stroke, no Thrombectomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

II - Ischemic Stroke, Thrombectomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

III - Hemorrhagic Stroke

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

Marijke van Vlimmeren

Philips Clinical & Medical Affairs Global

Phone: +31 6 31042408

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place