Next Generation X-ray Imaging System

Philips

Status: Completed

Conditions: Stroke, Acute

Study type: Observational

Funder types: Industry

Identifiers

NCT04571099

XCY612-130814

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design