Ignite Creation Date:
2024-05-06 @ 1:27 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01819597
Status:
COMPLETED
Last Update Posted:
2019-05-10
First Post:
2013-03-24
Brief Title:
Surgical Indirect Revascularization For Symptomatic Intracranial Arterial Stenosis
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
EDAS Surgical Revascularization for Symptomatic Intracranial Arterial Stenosis
Status:
COMPLETED
Status Verified Date:
2019-05
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:
ERSIAS
Brief Summary:
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
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
Detailed Description:
Intracranial arterial atherosclerosis is a significant medical problem with elevated rates of recurrent stroke despite medical therapy with annual recurrence rates for ischemic stroke reported in the SAMMPRIS Trial as high as 122 in the intensive medical therapy arm The incidence of recurrence stroke can be even higher in some high-risk groups as high as 25 in African-Americans and females The ultimate goal of this project is to advance a promising surgical treatment for symptomatic atherosclerotic intracranial stenosis - encephaloduroarteriosynangiosis EDAS Compared with direct revascularization operations bypass EDAS has the advantages of being less technically demanding avoiding temporary occlusion of cerebral vessels and allowing gradual development of collateral circulation where the brain demands it deterring early hyperperfusion and hemorrhage There has been no systematic trial exploring the use of EDAS in cases of symptomatic non-moyamoya intracranial arterial stenosis Based on preliminary positive results the investigators propose the long-term objective of demonstrating that EDAS improves the outcome in patients with symptomatic intracranial stenosis compared with aggressive medical therapy This will require future phase III clinical trials The present proposal has the purpose of testing in a phase II futility-design 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 present project will be 4-year futility-design trial to determine if 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 at two years in patients with symptomatic intracranial arterial stenosis Specific Aim 1 During the investigation the investigators will systematically evaluate the time course of collateralogenesis and perfusion improvement following EDAS by using quantitative and semiquantitative perfusion MRI studies Specific Aim 2 The new knowledge generated by this study on understanding the role of collateral circulation in stroke pathophysiology patient selection and use of non-invasive imaging will be useful not only for EDAS evaluation but potentially next generation stents and future novel medical therapies such as use of angiogenic growth factors andor endothelial stem cells
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None