Surgical Indirect Revascularization For Symptomatic Intracranial Arterial Stenosis (ERSIAS)
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|ClinicalTrials.gov Identifier: NCT01819597|
Recruitment Status : Completed
First Posted : March 27, 2013
Results First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Stroke due to intracranial arterial atherosclerosis is a significant medical problem, carrying one of the highest rates of recurrent stroke despite best medical therapy, with annual recurrence rates as elevated as 25% in high risk groups.
The goal of this investigation is to advance a promising surgical treatment for symptomatic atherosclerotic intracranial stenosis - encephaloduroarteriosynangiosis (EDAS). The investigation will test in a phase II futility trial the potential of EDAS for further development before proceeding with the design of a definitive clinical trial of EDAS Revascularization in patients with Symptomatic Intracranial Arterial Stenosis (ERSIAS).
The investigation is a 4-year futility trial to test the hypothesis that EDAS revascularization combined with aggressive medical therapy warrants further evaluation in a subsequent pivotal trial as an alternative to aggressive medical management alone for preventing the primary endpoint of stroke or death in patients with symptomatic intracranial arterial stenosis (Specific Aim 1). During the investigation the time course of collateralogenesis and perfusion improvement following EDAS will also be evaluated (Specific Aim 2.
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Arterial Stenosis Intracranial Atherosclerosis Ischemic Stroke Cerebral Angiogenesis||Procedure: Encephaloduroarteriosynangiosis (EDAS)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||EDAS surgery for Intracranial atherosclerosis. Non-futility design|
|Masking:||None (Open Label)|
|Official Title:||EDAS (Surgical) Revascularization for Symptomatic Intracranial Arterial Stenosis|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
EDAS surgery is an established form of indirect revascularization. The study arm in this study will receive EDAS surgery
Procedure: Encephaloduroarteriosynangiosis (EDAS)
The operation is a form of indirect revascularization or EC-IC bypass, performed under general endotracheal anesthesia, with intraoperative electroencephalographic monitoring. The surgery consists in the dissection and relocation of the superficial temporal artery (STA) and middle meningeal artery (MMA) branches, which are separated from their surrounding tissues under microscopic visualization and re-routed through a craniotomy to be placed intracranially in close proximity to the branches of the middle cerebral artery (MCA). The MCA branches are dissected in the arachnoid space and the STA and MMA are kept in position with microsutures to the arachnoid or MMA dural cuffs, maintaining close contact between the EC and MCA branches.
- Stroke or Death in the Territory of Qualifying Artery [ Time Frame: 1 year ]
The primary study endpoint is the number of participants with any stroke or death within 30 days after enrollment, or any ischemic stroke or death attributable to ischemia in the territory of the qualifying artery at one year.
Ischemic stroke is defined as a new focal neurological deficit of sudden onset, lasting at least 24 hours and not associated with CT or MRI findings of hemorrhage.
- Myocardial Infarction [ Time Frame: 30 days ]Number of participants with heart attack within 30 days of surgery
- Major Non-stroke Hemorrhage [ Time Frame: 2 years ]Number of participants with systemic hemorrhage, subdural or epidural hemorrhages
- Functional Outcome [ Time Frame: 2 years ]
Proportion of participants with good functional outcome at the end of follow-up measured by the modified Rankin scale (mRS). That is with mRS scores between 0 and 2.
Modified Rankin Scale
Score and Description:
0 - No symptoms at all
- - No significant disability despite symptoms; able to carry out all usual duties and activities
- - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- - Moderate disability; requiring some help, but able to walk without assistance
- - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- - Severe disability; bedridden, incontinent and requiring constant nursing care and attention
- - Dead
- Cognitive Outcome [ Time Frame: 2 years ]Mean cognitive outcome at the end of follow-up measured by the Montreal Cognitive Assessment (MoCA). Scores on the MoCA scale range between 0 and 30. Higher values represent a better outcome. A normal score on the MoCA scale is 26 or higher.
- Improved Collaterals [ Time Frame: 1 year ]
Number of participants with an increase by at least one grade on the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) Collateral Flow Grading System
The ASITN/SIR Collateral Flow Grading System has 4 grades:
0=no collaterals visible to the ischemic site.
- slow collaterals to the periphery of the ischemic site with persistence of some of the defect
- rapid collaterals to periphery of ischemic site with persistence of some of the defect and to only a portion of the ischemic territory
- collaterals with slow but complete angiographic blood flow of the ischemic bed by the late venous phase
- complete and rapid collateral blood flow to the vascular bed in the entire ischemic territory by retrograde perfusion.
Grade 4 represents the best outcome. Grade 0 represents the worst outcome.
- Asymptomatic Cerebral Hemorrhage [ Time Frame: 1 year ]Asymptomatic cerebral hemorrhage, defined as parenchymal or intraventricular bleeding detected in any imaging modality that is not associated with neurological deficits.
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): NCT01819597
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Nestor R Gonzalez, MD, MSCR||Cedars Sinai Neurosurgery|