Trial Outcomes & Findings for Surgical Indirect Revascularization For Symptomatic Intracranial Arterial Stenosis (NCT NCT01819597)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

52 participants

Primary outcome timeframe

1 year

Results posted on

2019-05-10

Participant Flow

Patients were recruited at UCLA Medical Center and Cedars Sinai Medical Center in Los Angeles.

Participant milestones

Participant milestones
Measure	EDAS Surgery EDAS surgery is an established form of indirect revascularization. The study arm in this study received EDAS surgery 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.
Overall Study STARTED	52
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Surgical Indirect Revascularization For Symptomatic Intracranial Arterial Stenosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EDAS Surgery n=52 Participants EDAS surgery is an established form of indirect revascularization. The study arm in this study will receive EDAS surgery 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	52.2 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	18 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	EDAS Surgery n=52 Participants EDAS surgery is an established form of indirect revascularization. The study arm in this study received EDAS surgery 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	5 Participants

SECONDARY outcome

Timeframe: 30 days

Number of participants with heart attack within 30 days of surgery

Outcome measures

Outcome measures
Measure	EDAS Surgery n=52 Participants EDAS surgery is an established form of indirect revascularization. The study arm in this study received EDAS surgery 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.
Myocardial Infarction	1 Participants

SECONDARY outcome

Timeframe: 2 years

Number of participants with systemic hemorrhage, subdural or epidural hemorrhages

Outcome measures

Outcome measures
Measure	EDAS Surgery n=52 Participants EDAS surgery is an established form of indirect revascularization. The study arm in this study received EDAS surgery 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.
Major Non-stroke Hemorrhage	0 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Good functional outcome (Modified Rankin Scores 0-2)

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 1. \- No significant disability despite symptoms; able to carry out all usual duties and activities 2. \- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. \- Moderate disability; requiring some help, but able to walk without assistance 4. \- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. \- Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. \- Dead

Outcome measures

Outcome measures
Measure	EDAS Surgery n=52 Participants EDAS surgery is an established form of indirect revascularization. The study arm in this study received EDAS surgery 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.
Functional Outcome	45 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Montreal Cognitive Outcome Assessment (MoCA)

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.

Outcome measures

Outcome measures
Measure	EDAS Surgery n=52 Participants EDAS surgery is an established form of indirect revascularization. The study arm in this study received EDAS surgery 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.
Cognitive Outcome	25.5 MoCA Score Standard Deviation 4.1

SECONDARY outcome

Timeframe: 1 year

Population: Evidence of angiographic neovasculariozation

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. 1. slow collaterals to the periphery of the ischemic site with persistence of some of the defect 2. rapid collaterals to periphery of ischemic site with persistence of some of the defect and to only a portion of the ischemic territory 3. collaterals with slow but complete angiographic blood flow of the ischemic bed by the late venous phase 4. 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.

Outcome measures

Outcome measures
Measure	EDAS Surgery n=52 Participants EDAS surgery is an established form of indirect revascularization. The study arm in this study received EDAS surgery 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.
Improved Collaterals	41 Participants

SECONDARY outcome

Timeframe: 1 year

Asymptomatic cerebral hemorrhage, defined as parenchymal or intraventricular bleeding detected in any imaging modality that is not associated with neurological deficits.

Outcome measures

Outcome measures
Measure	EDAS Surgery n=52 Participants EDAS surgery is an established form of indirect revascularization. The study arm in this study received EDAS surgery 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.
Asymptomatic Cerebral Hemorrhage	0 Participants

Adverse Events

EDAS Surgery

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	EDAS Surgery n=52 participants at risk EDAS surgery is an established form of indirect revascularization. The study arm in this study received EDAS surgery 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.
Cardiac disorders Death with 30 days of surgery	1.9% 1/52 • Number of events 1 • 1 year All adverse events were adjudicated by independent neurologists not involved in the surgical procedure

Other adverse events

Other adverse events
Measure	EDAS Surgery n=52 participants at risk EDAS surgery is an established form of indirect revascularization. The study arm in this study received EDAS surgery 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.
Musculoskeletal and connective tissue disorders Wound dehiscenece	3.8% 2/52 • Number of events 2 • 1 year All adverse events were adjudicated by independent neurologists not involved in the surgical procedure

Additional Information

Nestor Gonzalez, MD. Professor of Neurosurgery

Cedars-Sinai Medical Center

Phone: 310 423 0783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place