Acute Ischemic StrokePhase 3SAVENCT07902791
Sevoflurane vs. Propofol for General Anesthesia in Patients With Acute Ischemic Stroke Treated With Endovascular Therapy
A Phase 3 study testing Sevoflurane and propofol (drug) in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Acute ischemic stroke occurs when a blood clot blocks blood flow to part of the brain. Patients with this condition may require endovascular therapy, a procedure used to remove the clot and restore blood flow. General anesthesia is sometimes needed during this procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Large Vessel Occlusion
- What is being tested?
- Sevoflurane and propofol (drug)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jun 2026to 31 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years.
- Acute ischemic stroke within 24 hours from last time seen well, requiring emergency endovascular treatment, with or without prior thrombolysis.
- Intracranial anterior circulation occlusion, including occlusions of the M1 or M2 segments of the middle cerebral artery and/or the terminal internal carotid artery (TICA). Tandem lesions involving extracranial segments of the internal carotid artery are also eligible.
- Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on baseline computed tomography (CT).
- Pre-stroke modified Rankin Scale (mRS) score of 0-3.
- Indication for general anesthesia at the start of the procedure (within 30 minutes from femoral puncture) due to patient confusion or lack of cooperation, technical difficulties, or the treating team's preference.
- Ability to provide informed consent by the patient or by a family member/legal representative.
Who cannot join
- Hemorrhagic lesions on baseline CT.
- Anterior cerebral artery (ACA) occlusion.
- Posterior circulation occlusion, including vertebral, basilar, or posterior cerebral arteries (PCA).
- Hemodynamic instability.
- Acute respiratory failure requiring orotracheal intubation.
- General anesthesia required because of complications during endovascular treatment.
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- Known hypersensitivity to propofol, sevoflurane, or any of their excipients.
- Personal or family history of malignant hyperthermia, or suspected susceptibility to malignant hyperthermia.
- History of a previous serious adverse reaction to halogenated anesthetics, including hepatotoxicity associated with their use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Pol Camps-Renom, +34935537143, pcamps@santpau.cat
About this study
Official title: Sevoflurane vs. Propofol for General Anesthesia in Patients With Acute Ischemic Stroke Treated With Endovascular Therapy (SAVE Trial)
Acute ischemic stroke occurs when a blood clot blocks blood flow to part of the brain. Patients with this condition may require endovascular therapy, a procedure used to remove the clot and restore blood flow. General anesthesia is sometimes needed during this procedure.
The SAVE trial compares two medicines used for general anesthesia in patients with acute ischemic stroke undergoing endovascular therapy: sevoflurane and propofol. The aim of the study is to determine whether the choice of anesthetic medicine affects the final volume of brain tissue damaged by the stroke.
Read more
Participants will be randomly assigned to receive either sevoflurane or propofol during general anesthesia. The final volume of the brain infarction will be assessed using magnetic resonance imaging (MRI) approximately 72 hours after treatment. Participants will also be followed for up to 90 days to assess their clinical outcomes.
The study plans to include 314 participants across seven hospitals in Spain. The results may help improve understanding of how the choice of anesthetic medicine affects outcomes in patients with acute ischemic stroke treated with endovascular therapy.
- Conditions
- Acute Ischemic Stroke, Large Vessel Occlusion
- Being tested
- Sevoflurane, propofol (drug)
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sevoflurane administered for general anesthesia in patients with acute ischemic stroke undergoing endovascular therapy, according to the study protocol.
propofol (drug)Drug
Propofol administered for general anesthesia in patients with acute ischemic stroke undergoing endovascular therapy, according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | Not described Receives: Drug: Sevoflurane |
| Propofol | Active comparator | Not described Receives: Drug: propofol (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final infarct volume on follow-up brain MRI
Final infarct volume (FIV) will be assessed using the Fluid-Attenuated Inversion Recovery (FLAIR) sequence on follow-up brain magnetic resonance imaging (MRI). Infarcted tissue will be identified and segmented, and the total infarct volume will be quantified in milliliters (mL). Images will be analyzed centrally by trained evaluators blinded to clinical outcomes.
Measured: 72 hours (±24 hours) after endovascular treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start22 Jun 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902791
- Sponsor's protocol ID
- IIBSP-SAV-2025-178
- Acronym
- SAVE
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane vs. Propofol for General Anesthesia in Patients With Acute Ischemic Stroke Treated With Endovascular Therapy (SAVE Trial)
- ClinicalTrials.gov ID
- NCT07902791
- Acronym / sponsor ID
- SAVE / IIBSP-SAV-2025-178
- Conditions
- Acute Ischemic Stroke, Large Vessel Occlusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute ischemic stroke occurs when a blood clot blocks blood flow to part of the brain. Patients with this condition may require endovascular therapy, a procedure used to remove the clot and restore blood flow. General anesthesia is sometimes needed during this procedure.
The SAVE trial compares two medicines used for general anesthesia in patients with acute ischemic stroke undergoing endovascular therapy: sevoflurane and propofol. The aim of the study is to determine whether the choice of anesthetic medicine affects the final volume of brain tissue damaged by the stroke.
Participants will be randomly assigned to receive either sevoflurane or propofol during general anesthesia. The final volume of the brain infarction will be assessed using magnetic resonance imaging (MRI) approximately 72 hours after treatment. Participants will also be followed for up to 90 days to assess their clinical outcomes.
The study plans to include 314 participants across seven hospitals in Spain. The results may help improve understanding of how the choice of anesthetic medicine affects outcomes in patients with acute ischemic stroke treated with endovascular therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: Sevoflurane |
| Propofol | Active comparator | Drug: propofol (drug) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age over 18 years.
- Acute ischemic stroke within 24 hours from last time seen well, requiring emergency endovascular treatment, with or without prior thrombolysis.
- Intracranial anterior circulation occlusion, including occlusions of the M1 or M2 segments of the middle cerebral artery and/or the terminal internal carotid artery (TICA). Tandem lesions involving extracranial segments of the internal carotid artery are also eligible.
- Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on baseline computed tomography (CT).
- Pre-stroke modified Rankin Scale (mRS) score of 0-3.
Key exclusion criteria (9 listed)
- Hemorrhagic lesions on baseline CT.
- Anterior cerebral artery (ACA) occlusion.
- Posterior circulation occlusion, including vertebral, basilar, or posterior cerebral arteries (PCA).
- Hemodynamic instability.
- Acute respiratory failure requiring orotracheal intubation.
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 |
|---|---|---|
| SevofluraneSevoflurane administered for general anesthesia in patients with acute ischemic stroke undergoing endovascular therapy, according to the study protocol. | Drug | Sevoflurane |
| propofol (drug)Propofol administered for general anesthesia in patients with acute ischemic stroke undergoing endovascular therapy, according to the study protocol. | Drug | Propofol |
Primary outcome
Final infarct volume on follow-up brain MRI
Time frame: 72 hours (±24 hours) after endovascular treatment
Final infarct volume (FIV) will be assessed using the Fluid-Attenuated Inversion Recovery (FLAIR) sequence on follow-up brain magnetic resonance imaging (MRI). Infarcted tissue will be identified and segmented, and the total infarct volume will be quantified in milliliters (mL). Images will be analyzed centrally by trained evaluators blinded to clinical outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sevoflurane and propofol (drug) in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pol Camps-Renom (+34935537143, pcamps@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final infarct volume on follow-up brain MRI (time frame: 72 hours (±24 hours) after endovascular treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.