Next Generation X-ray Imaging System

• Sponsor: Philips Clinical & Medical Affairs Global (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04571099
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Actual Duration (Months): 5.6
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute

Study Design

• Study Type: Observational
• Actual Enrollment: 28 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Next Generation X-ray Imaging System
• Actual Study Start Date: Oct 8, 2020
• Actual Primary Completion Date: Mar 26, 2021
• Actual Study Completion Date: Mar 26, 2021

Outcome Measures

Primary Outcome Measures

1. Ischemic stroke diagnostic accuracy [Within 2 days after procedure]

   Accuracy of ASPECTS score to determine the extent and localization of ischemic stroke changes in brain tissue, evaluated by three independent neuroradiologists.

Secondary Outcome Measures

1. Vessel tree visibility [Within 2 days after procedure]

   Proportion of images made with new investigational device rated non-inferior vessel visibility compared to CTA (reference standard)

2. Intracranial hemorrhage detection accuracy [Within 2 days after procedure]

   Accuracy of images made with new investigational device to determine the presence of intracranial hemorrhage using neCT as the reference standard

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska University Hospital	Stockholm		Sweden

Sponsors and Collaborators

• Philips Clinical & Medical Affairs Global

Investigators

• Principal Investigator: Michael Söderman, MD, Karolinska University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philips Clinical & Medical Affairs Global
• ClinicalTrials.gov Identifier: NCT04571099
• Other Study ID Numbers: XCY612-130814
• First Posted: Sep 30, 2020
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Mar 22, 2022