StrokePhase 4SEGANCT03263117
SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke
A Phase 4 study testing Sedation, General Anesthesia (GA) and Intra-arterial Thrombectomy in people with Stroke, run by The University of Texas Health Science Center, Houston at 11 sites in United States.
Trial summary
Objectives: This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Sedation, General Anesthesia (GA) and Intra-arterial Thrombectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Jul 2018to 22 Apr 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke due to large intracranial vessel occlusion demonstrated on CT-angiography in the following anterior circulation locations that will be treated by endovascular therapy (EVT):
- Internal Carotid Artery (terminal "T" or "L-type"- occlusion)
- Middle Cerebral Artery (MCA) M1 or proximal M2
- Anterior Cerebral Artery (ACA) A1 or proximal A2
- Patients who receive IV-tPA thrombolysis are eligible provided the drug was delivered within 4.5 hours of stroke onset or last seen normal and in accordance with local hospital standard of care.
- Ages 18-90.
Show all 16Show fewer
- National Institute of Health Stroke Scale (NIHSS) score 6-30
- Time of from stroke symptom onset of last seen normal to start of EVT (defined as groin puncture) ≤ 16 hours.
- Limited infarct core, as defined below and adapted from the 2018 American Heart Association guidelines
- For patients presenting ≤ 6 hours from time of symptom onset or last seen normal, Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥ 6
- For patients presenting > 6 hours and ≤ 16 hours from time of symptom onset or last seen normal, they must satisfy EITHER ONE of the two following criteria:
- Ischemic core by CT Perfusion or MRI/MR Perfusion < 70 mL, a ratio of volume of penumbral tissue to infarct core of ≥ 1.8, and and absolute volume of penumbral tissue of ≥ 15 mL OR ii. For patients with NIHSS ≥ 10, infarct core of < 31 mL by CT Perfusion or MRI; For patients with NIHSS ≥ 20, infarct core < 51 mL.
- Subject willing/able to return for protocol required follow up visits.
- No significant pre-stroke disability (modified Rankin Score must be ≤ 2).
- Females of childbearing potential must have a negative serum or urine pregnancy test.
- Patient or patient's legally authorized representative has given Informed Consent according to Good Clinical Practices (GCP) and/or local IRB policies.
Who cannot join
- Coma on admission (Glasgow Coma Scale <8), need for intubation upon ED arrival, or transferred patients who present previously intubated.
- Severe agitation or seizures on admission that preclude safe vascular access.
- Loss of airway protective reflexes and/or vomiting on admission.
- Predicted or known difficult airway.
- Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia.
- Presumed septic embolus, or suspicion of bacterial endocarditis
Show all 10Show fewer
- Currently participating or has participated in any investigational drug or device study within 30 days.
- Inability to follow-up for 90-day assessment.
- Known history of allergy to anesthesia drugs.
- Known history or family history of malignant hyperthermia
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Geisinger Health
Danville, Pennsylvania, 17822
Memorial Hermann Hospital System - Memorial City Medical Center
Houston, Texas, 77024
Baylor College of Medicine
Houston, Texas, 77030
University of Texas Health Science Center Houston with Memorial Hermann Hospital System - The Medical Center
Houston, Texas, 77030
Indiana University College of Medicine
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Henry Ford Health System
Louisville, Kentucky, 48150
Temple University
Philadelphia, Pennsylvania, 19122
Rochester Regional Health
Rochester, New York, 14617
Memorial Hermann Hospital System - The Woodlands Medical Center
The Woodlands, Texas, 77380
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: SEGA - SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke - a Randomized Comparative Effectiveness Trial.
Objectives:
This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of symptomatic intracranial hemorrhage); rates of Endovascular therapy (EVT) procedural complications, reperfusion; and quality of life.
Hypothesis:
GA during EVT for acute ischemic stroke improves functional outcomes at 90 days compared to sedation.
- Conditions
- Stroke
- Being tested
- Sedation, General Anesthesia (GA), Intra-arterial Thrombectomy
- Keywords
- Acute stroke, Cerebral Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SedationDrug
The protocol does not specify a particular combination of drugs that must be used for sedation.
The most common drugs utilized for sedation and wide dosing ranges are included in the protocol (i.e., sedation will be provided under the supervision of an anesthesiologist and may use a combination of fentanyl, midazolam, dexmedetomidine infusion (with or without loading dose), and/or low-dose propofol by intermittent bolus or infusion); however, the choice of specific drugs and dosages for achieving conscious sedation or general anesthesia will not be specified by the protocol but will be up to the anesthesiologist.
General Anesthesia (GA)Drug
The protocol doesn't specify drugs that must be used for GA, the choice of drugs and dosages for achieving general anesthesia will not be specified by the protocol but will be up to the anesthesiologist.
The most common drugs utilized for GA and wide dosing ranges included in the protocol are (GA will be provided under the supervision of an anesthesiologist and induction of anesthesia may be achieved with propofol and/or etomidate; muscle paralysis may be achieved with succinylcholine or non-depolarizing paralytic (rocuronium or vecuronium); and adjuvant lidocaine and fentanyl; if intravenous maintenance of anesthesia is used, it may be achieved by propofol infusion at 50 to 150 mcg/kg/min with redosing of non-depolarizing paralytic and fentanyl as needed; if inhalational maintenance of anesthesia is used it will be achieved with sevoflurane 1% to 2% or desflurane 3% to 6% end-tidal concentration with redosing of non-depolarizing paralytic and fentanyl as needed)
Intra-arterial ThrombectomyProcedure or surgery
Also called Endovascular Therapy
The first line therapeutic embolectomy device should be a stent retriever. Additional Endovascular therapies including, but not limited to, intra- or extracranial angioplasty ± stenting; antithrombotics (oral, IV or IA antiplatelets or anticoagulants) intra-arterial thrombolytics; are left to the decision of the local treatment team.
| Study group | Role | What they receive |
|---|---|---|
| Sedation | Active comparator | The protocol does not specify a particular combination of drugs that must be used for sedation. The choice of specific drugs and dosages for achieving sedation will be up to the anesthesiologist. Receives: Drug: Sedation; Procedure: Intra-arterial Thrombectomy |
| General Anesthesia | Active comparator | The protocol does not specify a particular combination of drugs that must be used for general anesthesia. The choice of specific drugs and dosages for achieving general anesthesia will be up to the anesthesiologist. Receives: Drug: General Anesthesia (GA); Procedure: Intra-arterial Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ordinal Rankin Scale (mRS)
mRS ranges from 0 to 6, with higher scores indicating greater disability. 6 categories are reported: number of participants who had a score of 0, 1, 2, 3, or 4 will be reported separately as 5 categories, and those who had a score of 5 or 6 will be combined and reported as a single category.
0: no symptoms/normal (physical, cognitive etc.)
- 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 from another individual (use of walking aids alone is not counted as 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
Measured: 90 days
Secondary outcomes (8)
Dichotomized Modified Ordinal Rankin Scale (mRS)
The modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability and where 0-2 is generally considered a good outcome with individuals assuming complete functional independence. 2 categories are reported: number of participants who had a score of 0-2, and number who had a score of 3-6.
0: no symptoms/normal (physical, cognitive etc.)
- 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 from another individual (use of walking aids alone is not counted as 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
Measured: 90 days
Number of Participants With Angiographic Reperfusion Defined as Modified a TICI Score of ≥ 2b
The thrombolysis in cerebral infarction (TICI) grading system is a tool for determining the response of thrombolytic therapy for ischemic stroke. The TICI grade ranges from 0 to 3, with a higher score indicating greater perfusion.
grade 0: no perfusion grade 1: penetration with minimal perfusion grade 2: partial perfusion grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal grade 3: complete perfusion
Measured: post procedure within 6 hours
Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS)
The National Institutes of Health Stroke Scale (NIHSS) is a tool used objectively quantify the impairment caused by a stroke. Total score ranges from 0 - 42, with a higher score indicating greater severity of impairment caused by stroke.
0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
Measured: 24-36 hours post procedure
Number of Participants With Functional Independence as Indicated by an mRS Score of 0, 1, or 2
The modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability and where 0-2 is generally considered a good outcome with individuals assuming complete functional independence.
0: no symptoms/normal (physical, cognitive etc.)
- 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 from another individual (use of walking aids alone is not counted as 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
Measured: 90 days
Quality of Life as Assessed by the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) Assessment
The EQ-5D-5L score ranges from -0.59 to 1, where 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.
Measured: 90 days
Number of Participants With Symptomatic Intracerebral Hemorrhage
Symptomatic intracerebral hemorrhage was defined using the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) definition, a ≥ 4 point increase in NIHSS score with a parenchymal hemorrhage type 2 within 36 hours.
Measured: 18-36 hours post procedure
Number of Participants With All-cause Mortality
Measured: 18-36 hours post procedure
Number of Participants With Procedural Complications
Measured: 18-36 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start1 Jul 2018
- Primary completion22 Apr 2023
- Study completion22 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Neurovascular
- Responsible party
- Principal investigator, Peng Roc Chen, MD, The University of Texas Health Science Center, Houston
- Investigators
- Peng Roc Chen, MD, Study chair, The University of Texas Health Science Center, HoustonAndrew Barreto, MD, Principal investigator, The University of Texas Health Science Center, HoustonCarlos Artime, MD, Principal investigator, The University of Texas Health Science Center, HoustonSunil Sheth, MD, Principal investigator, The University of Texas Health Science Center, HoustonSean Savitz, MD, Principal investigator, The University of Texas Health Science Center, HoustonClaudia Pedroza, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263117
- Sponsor's protocol ID
- HSC-MS-17-0436
- Acronym
- SEGA
- Status last verified
- Sep 2025
- First submitted
- 16 Aug 2017
- Last updated
- 26 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chen PR, Artime CA, Sheth SA, Pedroza C, Ortega-Gutierrez S, Wolfe S, Sitton C, Kan P, Tanweer O, Chebl A, Schirmer CM, Morrow JT, Alderazi YJ, Bohnstedt B, Erkmen K, Samaniego EA, Garrido E, Savitz SI, Engstrom A, Aguilar E, Nguyen T, Barreto AD; SEGA Investigators. Sedation vs General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke: The SEGA Randomized Clinical Trial. JAMA Neurol. 2025 Dec 1;82(12):1265-1273. doi: 10.1001/jamaneurol.2025.3775.
PubMed 41082222Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2.
PubMed 35857365
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEGA - SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke - a Randomized Comparative Effectiveness Trial.
- ClinicalTrials.gov ID
- NCT03263117
- Acronym / sponsor ID
- SEGA / HSC-MS-17-0436
- Conditions
- Stroke
- Keywords
- Acute stroke, Cerebral Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Stryker Neurovascular
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 22 Apr 2023 (actual)
- Study completion
- 22 Apr 2023 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Posted 5 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of symptomatic intracranial hemorrhage); rates of Endovascular therapy (EVT) procedural complications, reperfusion; and quality of life.
Hypothesis:
GA during EVT for acute ischemic stroke improves functional outcomes at 90 days compared to sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation | Active comparator | Drug: Sedation, Procedure: Intra-arterial ThrombectomyThe protocol does not specify a particular combination of drugs that must be used for sedation. The choice of specific drugs and dosages for achieving sedation will be up to the anesthesiologist. |
| General Anesthesia | Active comparator | Drug: General Anesthesia (GA), Procedure: Intra-arterial ThrombectomyThe protocol does not specify a particular combination of drugs that must be used for general anesthesia. The choice of specific drugs and dosages for achieving general anesthesia will be up to the anesthesiologist. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Acute ischemic stroke due to large intracranial vessel occlusion demonstrated on CT-angiography in the following anterior circulation locations that will be treated by endovascular therapy (EVT):
- Ages 18-90.
- National Institute of Health Stroke Scale (NIHSS) score 6-30
- Time of from stroke symptom onset of last seen normal to start of EVT (defined as groin puncture) ≤ 16 hours.
- Limited infarct core, as defined below and adapted from the 2018 American Heart Association guidelines
Key exclusion criteria (10 listed)
- Coma on admission (Glasgow Coma Scale <8), need for intubation upon ED arrival, or transferred patients who present previously intubated.
- Severe agitation or seizures on admission that preclude safe vascular access.
- Loss of airway protective reflexes and/or vomiting on admission.
- Predicted or known difficult airway.
- Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SedationThe protocol does not specify a particular combination of drugs that must be used for sedation. The most common drugs utilized for sedation and wide dosing ranges are included in the protocol (i.e., sedation will be provided under the supervision of an anesthesiologist and may use a combination of fentanyl, midazolam, dexmedetomidine infusion (with or without loading dose), and/or low-dose propofol by intermittent bolus or infusion); however, the choice of specific drugs and dosages for achieving conscious sedation or general anesthesia will not be specified by the protocol but will be up to the anesthesiologist. | Drug | Sedation |
| General Anesthesia (GA)The protocol doesn't specify drugs that must be used for GA, the choice of drugs and dosages for achieving general anesthesia will not be specified by the protocol but will be up to the anesthesiologist. The most common drugs utilized for GA and wide dosing ranges included in the protocol are (GA will be provided under the supervision of an anesthesiologist and induction of anesthesia may be achieved with propofol and/or etomidate; muscle paralysis may be achieved with succinylcholine or non-depolarizing paralytic (rocuronium or vecuronium); and adjuvant lidocaine and fentanyl; if intravenous maintenance of anesthesia is used, it may be achieved by propofol infusion at 50 to 150 mcg/kg/min with redosing of non-depolarizing paralytic and fentanyl as needed; if inhalational maintenance of anesthesia is used it will be achieved with sevoflurane 1% to 2% or desflurane 3% to 6% end-tidal concentration with redosing of non-depolarizing paralytic and fentanyl as needed) | Drug | General Anesthesia |
| Intra-arterial ThrombectomyAlso: Endovascular TherapyThe first line therapeutic embolectomy device should be a stent retriever. Additional Endovascular therapies including, but not limited to, intra- or extracranial angioplasty ± stenting; antithrombotics (oral, IV or IA antiplatelets or anticoagulants) intra-arterial thrombolytics; are left to the decision of the local treatment team. | Procedure or surgery | General Anesthesia, Sedation |
Primary outcome
Modified Ordinal Rankin Scale (mRS)
Time frame: 90 days
mRS ranges from 0 to 6, with higher scores indicating greater disability. 6 categories are reported: number of participants who had a score of 0, 1, 2, 3, or 4 will be reported separately as 5 categories, and those who had a score of 5 or 6 will be combined and reported as a single category. 0: no symptoms/normal (physical, cognitive etc.) 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 from another individual (use of walking aids alone is not counted as 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
8 secondary outcomes
Dichotomized Modified Ordinal Rankin Scale (mRS)
Time frame: 90 days
Number of Participants With Angiographic Reperfusion Defined as Modified a TICI Score of ≥ 2b
Time frame: post procedure within 6 hours
Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS)
Time frame: 24-36 hours post procedure
Number of Participants With Functional Independence as Indicated by an mRS Score of 0, 1, or 2
Time frame: 90 days
Quality of Life as Assessed by the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) Assessment
Time frame: 90 days
Number of Participants With Symptomatic Intracerebral Hemorrhage
Time frame: 18-36 hours post procedure
Number of Participants With All-cause Mortality
Time frame: 18-36 hours post procedure
Number of Participants With Procedural Complications
Time frame: 18-36 hours post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41082222Chen PR, Artime CA, Sheth SA, Pedroza C, Ortega-Gutierrez S, Wolfe S, Sitton C, Kan P, Tanweer O, Chebl A, Schirmer CM, Morrow JT, Alderazi YJ, Bohnstedt B, Erkmen K, Samaniego EA, Garrido E, Savitz SI, Engstrom A, Aguilar E, Nguyen T, Barreto AD; SEGA Investigators. Sedation vs General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke: The SEGA Randomized Clinical Trial. JAMA Neurol. 2025 Dec 1;82(12):1265-1273. doi: 10.1001/jamaneurol.2025.3775.
- Derived from this study: PubMed 35857365Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng Roc Chen, MD study chair
The University of Texas Health Science Center, Houston
Andrew Barreto, MD principal investigator
The University of Texas Health Science Center, Houston
Carlos Artime, MD principal investigator
The University of Texas Health Science Center, Houston
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sedation, General Anesthesia (GA) and Intra-arterial Thrombectomy in people with Stroke, run by The University of Texas Health Science Center, Houston at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ordinal Rankin Scale (mRS) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03263117, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.