Next Generation X-ray Imaging System

Stroke, Acute Clinical Trial

Official title:

Next Generation X-ray Imaging System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04571099
• Other study ID #: XCY612-130814
• Status: Completed
• Start date: October 8, 2020
• Est. completion date: March 26, 2021

Study information

• Verified date: March 2022
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 26, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic stroke diagnostic accuracy	Accuracy of ASPECTS score to determine the extent and localization of ischemic stroke changes in brain tissue, evaluated by three independent neuroradiologists.	Within 2 days after procedure
Secondary	Vessel tree visibility	Proportion of images made with new investigational device rated non-inferior vessel visibility compared to CTA (reference standard)	Within 2 days after procedure
Secondary	Intracranial hemorrhage detection accuracy	Accuracy of images made with new investigational device to determine the presence of intracranial hemorrhage using neCT as the reference standard	Within 2 days after procedure