IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
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|ClinicalTrials.gov Identifier: NCT03396419|
Recruitment Status : Terminated (Terminated following the completion of ImpACT-24B study)
First Posted : January 11, 2018
Last Update Posted : April 24, 2019
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||A Sub-Study of the ImpACT-24B Trial (CLP1000500) Assessing Brain Collateral Blood Flow Enhancement Following Spheno-Palatine Ganglion (SPG) Stimulation in Subjects With Acute Ischemic Stroke|
|Actual Study Start Date :||September 25, 2017|
|Actual Primary Completion Date :||June 3, 2018|
|Actual Study Completion Date :||June 3, 2018|
Acute Isch. Stk pts treat. w/SPG stimul.
Following implantation (according to the ImpACT-24B protocol), subjects will be transferred to the angio suite. A baseline brain digital subtraction angiography (DSA) will then be performed by a trained physician prior to initiation of SPG stimulation according to the ImpACT-24B protocol.
Following the first SPG stimulation cycle of 4 minutes, a post-stimulation DSA will be performed.
Based on the results of the post-stimulation DSA, the physician may perform an additional DSA following the second SPG stimulation cycle.
The subject will then be transferred to the stroke department and will continue treatment according the ImpACT-24B protocol.
- Collateral blood flow grades difference following SPG stimulation. [ Time Frame: Day 1 ]The difference between the collateral blood flow grades, assessed by DSA, at baseline and following SPG stimulation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396419
|High Technology Medical Center University Clinic LTD.|
|Tbilisi, Georgia, 0144|
|Study Director:||Yoram Slolberg, Dr.||BrainsGate|