Clinical trial NCT04571099: Next Generation X-ray Imaging System
Official title: Next Generation X-ray Imaging System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2020-09-30
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ischemic Stroke Diagnostic Accuracy (CBCT Versus CT)
timeFrame: Within 2 days after procedure
Secondary outcomes:
measure: Percentage of Dual Layer CBCT Images With Non-inferior Vessel Tree Visibility Compared to CTA (Reference Standard)
timeFrame: Within 2 days after procedure
measure: Intracranial Hemorrhage Detection Accuracy (CBCT With CT as Reference Standard)
timeFrame: Within 2 days after procedure
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Michael Söderman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.