Aneurysmal Subarachnoid HemorrhageSAVEBRAINNCT05268445
Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)
A study testing Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis in people with Aneurysmal Subarachnoid Hemorrhage and Vasospasm, Intracranial, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
This is a monocentric randomized prospective trial comparing 2 different endovascular strategies of intracranial arterial angioplasty in case of refractory intracranial arterial vasospastic stenosis : chemical angioplasty chemical and mechanical angioplasty Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage, Vasospasm, Intracranial, Stenosis
- What is being tested?
- Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2022to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Non-traumatic intracranial hemorrhage (ruptured aneurysm, AVM, or per-procedural complication etc)
- Ruptured aneurysm, AVM, intracranial arterial perforation or any bleeding lesion secured with surgical clipping or endovascular intervention.
- No contra-indication to both CTP and MRI imaging
- Subject or legal representative is able and willing to give informed consent.
- Refractory of intracranial arterial vasospastic stenosis requiring an endovascular angioplasty with a severe stenosis defined on CTA or DSA; and/or a significant hypoperfusion defined according to the mismatch profile in stroke or a MTT>6 seconds. The volume of critically hypoperfused tissue will be based on a time to maximum of the tissue residue function (Tmax) threshold of >6 sec using the Rapid (or equivalent) software.
Who cannot join
- Angioplasty by one of the two methods considered as impossible or too risky by the neurointerventionist
- Inability to obtain consent from patient or patients relatives
- Pregnant women
- Less than 18 years of age
- Need to use any other device
- Vertebro-basilar arteries will not be randomized because of the difficulty to assess the perfusion volume in this territory, but will be treated if necessary according to our local protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Validated Endovascular Strategies for Refractory Vasospastic Stenosis After Non-traumatic Intracranial Haemorrhage Leading to Severe Brain Hypoperfusion: Chemical Versus Chemical and Mechanical Angioplasty
This is a monocentric randomized prospective trial comparing 2 different endovascular strategies of intracranial arterial angioplasty in case of refractory intracranial arterial vasospastic stenosis :
- chemical angioplasty
- chemical and mechanical angioplasty
Read the detailed description
Compare in a randomized prospective trial 2 approved treatments of refractory intracranial arterial vasospastic stenosis, chemical angioplasty versus chemical and mechanical angioplasty, using devices already used in clinical practice and CE marked: chemical angioplasty using Nimotop versus chemical and mechanical angioplasty with balloon or adjustable remodeling mesh on brain perfusion evaluated by brain computed tomography (CT) Perfusion
Nowadays, the choice between chemical or chemical and mechanical angioplasty depends on the neurointerventionist for each procedure, no difference in efficiency or safety has been proved and no solid scientific data helps the physician in choosing the correct treatment for each patient.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage, Vasospasm, Intracranial, Stenosis, Ruptured Cerebral Aneurysm, Arteriovenous Malformations, Cerebral, Arteriovenous Fistula
- Being tested
- Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial, Constriction, Pathologic, Intracranial Arteriovenous Malformations, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic StenosisProcedure or surgery
Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis
| Study group | Role | What they receive |
|---|---|---|
| Chemical angioplasty | Active comparator | Chemical angioplasty using intra-arterial Nimodipin Receives: Procedure: Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis |
| Chemical and Mechanical angioplasty | Active comparator | Balloon angioplasty for refractory intracranial arterial vasospastic stenosis with a CE Marked device (Neurospeed balloon) or Adjustable remodeling mesh angioplasty for refractory intracranial arterial vasospastic stenosis with a CE Marked device (Comaneci) in association with intra-arterial Nimodipin Receives: Procedure: Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain hypoperfusion
Brain hypoperfusion in arterial territories assessed by the delays on perfusion Time to drain (seconds) on CT and/or MR perfusion
Measured: Change between day 0 and day 1 after the endovascular procedure and randomization
Secondary outcomes (11)
Change in vessel size
Change in the vessel size measured on digital subtraction angiography (DSA) and computed tomography angiogram (CTA) in millimeters
Measured: Change between day 0 and day 1 after the endovascular procedure and randomization
Time to next endovascular intervention for vasospastic stenosis
Delay between two procedures for the same indication
Measured: Number of days after the endovascular procedure until the next procedure in days, up to 4 weeks
modified Rankin Scale at 3 months
clinical evolutionclinical evolution (mRS between 0 and 6, a higher score means a worse outcome)
Measured: 3 months after Intracranial Hemorrhage
Change in Transcranial Doppler
Change in intracranial vasospasm assessed by the targeted vessel velocity in meters per second
Measured: Change between day 0 and day 1 after the endovascular procedure and randomization
change in Brain Hypoperfusion 2
Reduction in brain hypoperfusion assessed by the volumes on different perfusion parameters time to peak (in seconds) on CT and/or MR perfusion
Measured: Change between day 0 and day 1 after the endovascular procedure and randomization
change in Glasgow coma scale
Glasgow coma scale (GCS between 3 and 15, a higher score means a better outcome)
Measured: Change between day 0 and day 1 after the endovascular procedure and randomization
change in National Institutes of Health Stroke Scale score
National Institutes of Health Stroke Scale (NIHSS between 0 and 42, a higher score means a worse outcome)
Measured: Change between day 0 and day 1 after the endovascular procedure and randomization
Change in the monitoring of tissue oxygen pressure (PtiO2)
Monitoring of tissue oxygen pressure (PtiO2)
Measured: Change between day 0 and day 1 after the endovascular procedure and randomization
Number of new ischemic lesions
Number of new ischemic lesions on non-contrast computed tomography (CT) scan
Measured: Change between day 0, 5, 9, 21 after Intracranial Hemorrhage
Change in brain hypoperfusion 3
Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters TMax maps in seconds on CT and/or MR perfusion
Measured: Change between day 0 and day 1 after the endovascular procedure and randomization
Change in brain hypoperfusion 4
Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters Mean transit time on CT and/or MR perfusion in seconds
Measured: Change between day 0 and day 1 after the endovascular procedure and randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 Mar 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization between chemical angioplasty and chemical plus mechanical angioplasty using an adjustable remodeling mesh or a balloon
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrien Guenego, MD, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268445
- Sponsor's protocol ID
- SRB2021297
- Acronym
- SAVEBRAIN
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2022
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing
Publications
Guenego A, Salim HA, Taccone FS, Heit JJ, Wang M, Sadeghi N, Ligot N, Wintermark M, Tannouri F, Lubicz B; SAVEBRAIN Consortium. Chemical Angioplasty Alone versus Chemical and Mechanical Angioplasty for Cerebral Vasospasm after Aneurysmal Hemorrhage: A Pilot Randomized Controlled Study. AJNR Am J Neuroradiol. 2026 Jul 1;47(7):1824-1831. doi: 10.3174/ajnr.A9194.
PubMed 41962956
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Validated Endovascular Strategies for Refractory Vasospastic Stenosis After Non-traumatic Intracranial Haemorrhage Leading to Severe Brain Hypoperfusion: Chemical Versus Chemical and Mechanical Angioplasty
- ClinicalTrials.gov ID
- NCT05268445
- Acronym / sponsor ID
- SAVEBRAIN / SRB2021297
- Conditions
- Aneurysmal Subarachnoid Hemorrhage, Vasospasm, Intracranial, Stenosis, Ruptured Cerebral Aneurysm, Arteriovenous Malformations, Cerebral, Arteriovenous Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 7 Mar 2022 (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.
This is a monocentric randomized prospective trial comparing 2 different endovascular strategies of intracranial arterial angioplasty in case of refractory intracranial arterial vasospastic stenosis :
- chemical angioplasty
- chemical and mechanical angioplasty
Detailed description
Compare in a randomized prospective trial 2 approved treatments of refractory intracranial arterial vasospastic stenosis, chemical angioplasty versus chemical and mechanical angioplasty, using devices already used in clinical practice and CE marked: chemical angioplasty using Nimotop versus chemical and mechanical angioplasty with balloon or adjustable remodeling mesh on brain perfusion evaluated by brain computed tomography (CT) Perfusion
Nowadays, the choice between chemical or chemical and mechanical angioplasty depends on the neurointerventionist for each procedure, no difference in efficiency or safety has been proved and no solid scientific data helps the physician in choosing the correct treatment for each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization between chemical angioplasty and chemical plus mechanical angioplasty using an adjustable remodeling mesh or a balloon
| Arm | Type | Receives |
|---|---|---|
| Chemical angioplasty | Active comparator | Procedure: Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic StenosisChemical angioplasty using intra-arterial Nimodipin |
| Chemical and Mechanical angioplasty | Active comparator | Procedure: Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic StenosisBalloon angioplasty for refractory intracranial arterial vasospastic stenosis with a CE Marked device (Neurospeed balloon) or Adjustable remodeling mesh angioplasty for refractory intracranial arterial vasospastic stenosis with a CE Marked device (Comaneci) in association with intra-arterial Nimodipin |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Non-traumatic intracranial hemorrhage (ruptured aneurysm, AVM, or per-procedural complication etc)
- Ruptured aneurysm, AVM, intracranial arterial perforation or any bleeding lesion secured with surgical clipping or endovascular intervention.
- No contra-indication to both CTP and MRI imaging
- Subject or legal representative is able and willing to give informed consent.
Key exclusion criteria (6 listed)
- Angioplasty by one of the two methods considered as impossible or too risky by the neurointerventionist
- Inability to obtain consent from patient or patients relatives
- Pregnant women
- Less than 18 years of age
- Need to use any other device
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 |
|---|---|---|
| Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic StenosisAngioplasty for Refractory Intracranial Arterial Vasospastic Stenosis | Procedure or surgery | Chemical and Mechanical angioplasty, Chemical angioplasty |
Primary outcome
Change in brain hypoperfusion
Time frame: Change between day 0 and day 1 after the endovascular procedure and randomization
Brain hypoperfusion in arterial territories assessed by the delays on perfusion Time to drain (seconds) on CT and/or MR perfusion
11 secondary outcomes
Change in vessel size
Time frame: Change between day 0 and day 1 after the endovascular procedure and randomization
Time to next endovascular intervention for vasospastic stenosis
Time frame: Number of days after the endovascular procedure until the next procedure in days, up to 4 weeks
modified Rankin Scale at 3 months
Time frame: 3 months after Intracranial Hemorrhage
Change in Transcranial Doppler
Time frame: Change between day 0 and day 1 after the endovascular procedure and randomization
change in Brain Hypoperfusion 2
Time frame: Change between day 0 and day 1 after the endovascular procedure and randomization
change in Glasgow coma scale
Time frame: Change between day 0 and day 1 after the endovascular procedure and randomization
change in National Institutes of Health Stroke Scale score
Time frame: Change between day 0 and day 1 after the endovascular procedure and randomization
Change in the monitoring of tissue oxygen pressure (PtiO2)
Time frame: Change between day 0 and day 1 after the endovascular procedure and randomization
Number of new ischemic lesions
Time frame: Change between day 0, 5, 9, 21 after Intracranial Hemorrhage
Change in brain hypoperfusion 3
Time frame: Change between day 0 and day 1 after the endovascular procedure and randomization
Change in brain hypoperfusion 4
Time frame: Change between day 0 and day 1 after the endovascular procedure and randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 41962956Guenego A, Salim HA, Taccone FS, Heit JJ, Wang M, Sadeghi N, Ligot N, Wintermark M, Tannouri F, Lubicz B; SAVEBRAIN Consortium. Chemical Angioplasty Alone versus Chemical and Mechanical Angioplasty for Cerebral Vasospasm after Aneurysmal Hemorrhage: A Pilot Randomized Controlled Study. AJNR Am J Neuroradiol. 2026 Jul 1;47(7):1824-1831. doi: 10.3174/ajnr.A9194.
- Individual participant dataSharing planned: No. No IPD sharing
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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.
Adrien Guenego, MD principal investigator
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis in people with Aneurysmal Subarachnoid Hemorrhage and Vasospasm, Intracranial, run by Erasme University Hospital at 1 site in Belgium.
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 6 inclusion and 6 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 21 Feb 2024. 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 Belgium. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in brain hypoperfusion (time frame: Change between day 0 and day 1 after the endovascular procedure and randomization). 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 NCT05268445, which also lists 1 linked publication.
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 21 Feb 2024.