Surgical Indirect Revascularization For Symptomatic Intracranial Arterial Stenosis (ERSIAS)
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.
Intracranial Arterial Stenosis
Procedure: Encephaloduroarteriosynangiosis (EDAS)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||EDAS (Surgical) Revascularization for Symptomatic Intracranial Arterial Stenosis|
- Stroke or death after enrollment [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]First primary study endpoint is stroke or death within 30 days after enrollment. 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. Symptomatic cerebral hemorrhage is defined as parenchymal, subarachnoid or intraventricular bleeding detected in any imaging modality that is associated with new neurological deficits. Hemorrhage would only contribute to the primary endpoint if it occurs within 30 days after surgery.
- Stroke or death in the territory of qualifying artery [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]The primary study endpoint is the composite of (1) any stroke or death within 30 days after enrollment, or (2) 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.
- Any stroke or death [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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: 2 years ] [ Designated as safety issue: Yes ]
- Major non-stroke hemorrhage [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Systemic hemorrhage, subdural or epidural hemorrhages
- Functional outcome [ Time Frame: 2 years ] [ Designated as safety issue: No ]Functional outcome at the end of follow-up measured by the modified Rankin scale and Barthel Index
- Cognitive outcome [ Time Frame: 2 years ] [ Designated as safety issue: No ]Cognitive outcome at the end of follow-up measured by the Montreal Cognitive Assessment
- Improved collaterals [ Time Frame: 1 year ] [ Designated as safety issue: No ]Increase by at least one grade on the ASITN/SIR Angiographic Collateral Flow scale at one year.
- Asymptomatic cerebral hemorrhage [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Asymptomatic cerebral hemorrhage, defined as parenchymal or intraventricular bleeding detected in any imaging modality that is not associated with neurological deficits.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||February 2018|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01819597
|Contact: Nestor R Gonzalez, MD., MSCR||(310)firstname.lastname@example.org|
|Contact: Patrick Lyden, MD||(310)email@example.com|
|United States, California|
|Cedars Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Nestor R Gonzalez, MD, FAHA 310-423-0783 firstname.lastname@example.org|
|Contact: Antoinette Anderson 310-423-0783 email@example.com|
|Principal Investigator: Nestor R Gonzalez, MD|
|Sub-Investigator: Jeffrey Saver, MD|
|Sub-Investigator: Patrick Lyden, MD|
|Sub-Investigator: Konrad Schlick, MD|
|Sub-Investigator: Shlee Song, MD|
|Principal Investigator:||Nestor R Gonzalez, MD, MSCR||Cedars Sinai Neurosurgery|