Next Generation X-ray Imaging System

Philips Healthcare has developed a next generation Allura investigational device. The intended purpose of the investigational device is to perform neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures on human patients. The goal of this study is to investigate the accuracy of the next generation Allura investigational device to determine the extent and localization of ischemic stroke changes in brain tissue.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with age 50 or older, of both genders. Patients are considered to be enrolled in the study after they have signed the informed consent form.

Description

Inclusion Criteria:

1. The patient has signed and dated the Informed Consent Form (ICF)
2. Age ≥ 50 years old
3. Clinical and radiological signs consistent with acute stroke I. Patient diagnosed with ischemic stroke of the anterior circulation and not eligible for thrombectomy. II. Patient diagnosed with ischemic stroke of the anterior circulation and subjected to thrombectomy. III. Patient diagnosed with hemorrhagic stroke.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Previous stroke or parenchymal damage/defects in anterior circulation territories (only applicable for subjects included by criterion 3.I or 3.II).
3. Subject participates in a potentially confounding drug or device trial during the course of the study.
4. Participation in the study exposes the subject to risk, as assessed at the discretion of the treating physician.
5. All subjects who meet an exclusion criteria according to national law.
6. Subject or subject family member is a known Philips employee.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischemic Stroke Diagnostic Accuracy (CBCT Versus CT)	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.	Within 2 days after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Dual Layer CBCT Images With Non-inferior Vessel Tree Visibility Compared to CTA (Reference Standard)	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.	Within 2 days after procedure
Intracranial Hemorrhage Detection Accuracy (CBCT With CT as Reference Standard)	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.	Within 2 days after procedure

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Principal Investigator: Michael Söderman, MD, Karolinska University Hospital

Publications and helpful links

General Publications

• Stahl F, Almqvist H, Kolloch J, Aspelin A, Gontu V, Hummel E, van Vlimmeren M, Simon M, Thran A, Holmberg A, Mazya MV, Soderman M, Delgado AF. Dual-Layer Detector Cone-Beam CT Angiography for Stroke Assessment: First-in-Human Results (the Next Generation X-ray Imaging System Trial). AJNR Am J Neuroradiol. 2023 May;44(5):523-529. doi: 10.3174/ajnr.A7835. Epub 2023 Apr 13. Erratum In: AJNR Am J Neuroradiol. 2023 Jul;44(7):E32. doi: 10.3174/ajnr.A7898.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): March 26, 2021
• Study Completion (Actual): March 26, 2021

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: XCY612-130814

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No