SAVE trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-04-07

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Compare the final volume of cerebral infarction by magnetic resonance imaging at 72 hours in patients with acute ischemic stroke undergoing mechanical thrombectomy under general anesthesia, who are randomly assigned to receive anesthetic maintenance with sevoflurane or propofol.

Secondary objectives 4

1. Compare in patients randomly assigned to receive anesthetic maintenance with sevoflurane or propofol during mechanical thrombectomy: The final infarct volume on control computed tomography (CT) at 24 hours, evaluated in a Core Lab by radiologists blinded to clinical information.
2. Safety variables: mortality, bronchial aspiration, cardiac conduction block, seizures, and the number and severity of procedure-related complications.
3. Procedural metrics, including the time from femoral puncture to the final image series.
4. The probability of a good functional outcome at 3 months post-procedure, defined as a score of 0–2 on the modified Rankin scale.

Conditions and MedDRA coding

Acute ischemic stroke

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age >18 years
2. Acute ischemic stroke within 24 hours from the last time seen well (LTSW), undergoing emergency endovascular treatment (EVT), with or without prior thrombolysis.
3. Intracranial occlusion in the anterior circulation, including occlusions in segments M1 and M2 of the middle cerebral artery and/or the terminal portion of the internal carotid artery (TICA). Tandem lesions affecting extracranial segments of the internal carotid artery will also be included.
4. Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on baseline computed tomography (CT).
5. Pre-stroke modified Rankin Scale (mRS) score of 0–3.
6. Indication for general anesthesia at the start of the procedure (<30 minutes from femoral puncture) due to one of the following reasons: • Confusion or lack of patient cooperation. • Technical difficulties, such as complex arterial access, vascular tortuosity, need for extra- or intracranial stent placement, distal/medium vessel occlusions, among others. • Treating team's preference.
7. Ability of the patient or the family member/legal representative to provide informed consent.

Exclusion criteria 9

1. Presence of hemorrhagic lesions on baseline CT.
2. Occlusions in the anterior cerebral artery (ACA).
3. Occlusions in the posterior circulation, including vertebral, basilar, or posterior cerebral arteries (PCA).
4. Hemodynamic instability.
5. Acute respiratory failure requiring orotracheal intubation
6. Decision to perform general anesthesia due to complications during the endovascular treatment.
7. Known hypersensitivity to propofol, sevoflurane, or any of their excipients.
8. Personal or family history of malignant hyperthermia, or suspected susceptibility to malignant hyperthermia (contraindication to halogenated anesthetics such as sevoflurane).
9. History of a previous severe adverse reaction to halogenated anesthetics, including hepatotoxicity associated with their use.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary outcome of the study will be the final infarct volume (FIV), assessed by Fluid-Attenuated Inversion Recovery (FLAIR) sequence on magnetic resonance imaging (MRI) follow-up at 72 hours post-treatment ± 24 hours.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Sponsor organisation

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Address

Calle Sant Quinti 77-79

City

Barcelona

Postcode

08041

Country

Spain

Scientific contact point

Organisation

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Contact name

Rosa M. Antonijoan Arbos

Public contact point

Organisation

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Contact name

Rosa M. Antonijoan Arbos

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications