Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375174
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Brief Title:
PRECISE PERFUSION IMAGING TO IDENTIFY POSTERIOR CIRCULATION CANDIDATES FOR THROMBECTOMY
Sponsor:
Dr med Carlo Cereda
Organization:
Ospedale Civico Lugano
Study Overview
Official Title:
SWISS-PRECISE PERFUSION IMAGING TO IDENTIFY POSTERIOR CIRCULATION CANDIDATES FOR THROMBECTOMY
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SWISS-PRECISE
Brief Summary:
We hypothesize that patients with a favorable Critical Area Perfusion Score CAPS3 on cerebral perfusion imaging will have a favorable response to revascularization by thrombectomy and that patients with a CAPS3 will not
Detailed Description:
PRECISE is a multicenter prospective observational cohort study SWISS-PRECISE is a Switzerland Based spin-off of PRECISE with the intention to perform a final pooled analysis of data
All procedures correspond to standard care and clinical routine Perfusion imaging will be acquired prior to thrombectomy treatment Enrolled patients have undergone standard of care baseline imaging with CT or MRI that includes angiography and cerebral perfusion imaging therefore will be performed a control-MRI or CT scan after 24 hours andor within 51 days from the thrombectomy or before discharge
Study procedures include the standard of care clinical follow-up assessments at uniform time intervals 51 days or discharge 307 days and 9014 days Data that will be collected on participants include 1 all brain imaging 2 demographics 3 limited history 4 blood pressure and vital signs before during and after thrombectomy treatment 5 NIHSS before and after thrombectomy treatment at hospital discharge and at days 30 and 90 if conducted in person 6 discharge disposition 7 modified Rankin Scale score prior to stroke at discharge and at days 30 and 90 mRS will be assessed either in person or by phone and 8 Quality of Life Assessment at day 90
All procedures correspond to standard care and clinical routine Perfusion imaging will be acquired prior to thrombectomy treatment Enrolled patients have undergone standard of care baseline imaging with CT or MRI that includes angiography and cerebral perfusion imaging therefore will be performed a control-MRI or CT scan after 24 hours andor within 51 days from the thrombectomy or before discharge
Study procedures include the standard of care clinical follow-up assessments at uniform time intervals 51 days or discharge 307 days and 9014 days Data that will be collected on participants include 1 all brain imaging 2 demographics 3 limited history 4 blood pressure and vital signs before during and after thrombectomy treatment 5 NIHSS before and after thrombectomy treatment at hospital discharge and at days 30 and 90 if conducted in person 6 discharge disposition 7 modified Rankin Scale score prior to stroke at discharge and at days 30 and 90 mRS will be assessed either in person or by phone and 8 Quality of Life Assessment at day 90
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None