Ischemic PostconditioningBRAIN-SAVENCT06359756
Ischemic Postconditioning in Carotid Surgery
A study testing Ischemic postconditioning in carotid surgery and Eversion Carotid Endarterectomy in people with Ischemic Postconditioning and Carotid Surgery, run by Institute for Cardiovascular Diseases Dedinje at 1 site in Serbia.
Trial summary
Analyzing changes in cerebral oximetry, transcranial Doppler and biomarkers of neuronal ischemic injury and blood-brain barrier integrity assessing the safety and efficacy of ischemic postconditioning in carotid surgery (IPCT). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Ischemic Postconditioning, Carotid Surgery, Stroke
- What is being tested?
- Ischemic postconditioning in carotid surgery and Eversion Carotid Endarterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Sep 2023to 1 Jan 2026
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral carotid artery stenosis >90%
- bilateral stenosis >80%
- unilateral stenosis >80% with contralateral occlusion/subocclusion
Who cannot join
- urgent carotid endarterectomy
- carotid restenosis
- "major surgery" in the last 6 months
- malignant diseases
- previous brain trauma or surgery
- epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ischemic Postconditioning in Prevention of Brain Damage After Carotid Surgery - a Clinical Trial for Vascular Evaluation
Analyzing changes in cerebral oximetry, transcranial Doppler and biomarkers of neuronal ischemic injury and blood-brain barrier integrity assessing the safety and efficacy of ischemic postconditioning in carotid surgery (IPCT).
Read the detailed description
Eversion carotid endarterectomy (eCEA) has proven effective in preventing ischemic brain damage resulting from atherosclerotic disease in the extracranial segment of the carotid arteries. Over time, advancements in surgical techniques have led to a reduction in the incidence of perioperative stroke. To better understand the concept of stroke complications following CEA, a clear distinction between intraprocedural and postprocedural strokes is necessary. Periprocedural strokes are attributed to hypoperfusion or embolization from the site of endarterectomy, while defined causes of postprocedural strokes include local carotid artery thrombosis or cerebral hyperperfusion syndrome (CHS).
CHS, occurring in 1-3% of cases, is a potentially catastrophic event following eCEA, primarily resulting from impaired autoregulation mechanisms and post-revascularization changes in cerebral hemodynamics. Patients with significant carotid stenosis are particularly vulnerable to CHS due to prolonged cerebral hypoperfusion, where collateral circulation serves as a protective mechanism. Another pathway leading to CHS involves increased free radical concentrations, damaging the blood-brain barrier. Identified risk factors for CHS development include advanced age, prior ischemic cerebrovascular events, and contralateral stenosis > 70%.
Various methods for predicting CHS development and collateral circulation insufficiency include cerebral oximetry, transcranial Doppler sonography, perfusion computed tomography, and quantitative magnetic resonance imaging. Cerebral oximetry, with real-time detection of cerebral oxygenated hemoglobin saturation, exhibits promising sensitivity and specificity in predicting CHS occurrence.
Analyzing changes in biomarkers of neuronal ischemic injury and blood-brain barrier integrity offers insight into CHS pathophysiology and indirectly assesses the safety and efficacy of ischemic postconditioning of the carotid artery (IPCT) in high-risk patients. IPCT, shown to have a protective effect in animal models, recently demonstrated encouraging results in human trials.
Utilizing intraoperative neuromonitoring with cerebral oximetry and transcranial Doppler enables real-time monitoring of cerebral oxygenated hemoglobin saturation and flow characteristics during and after IPCT, validating its protective effect and safety in high-risk CHS scenarios.
- Being tested
- Ischemic postconditioning in carotid surgery, Eversion Carotid Endarterectomy
- Keywords
- Ischemic Postconditioning, Carotid Surgery
- Medical subject headings
- Stroke, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic postconditioning in carotid surgeryProcedure or surgery
Also called IPCT
After the initial declamping of the carotid artery the procedure is performed with 6 cycles of reperfusion of 30 seconds each (clamping of the internal carotid artery) which are successively followed by 6 cycles of ischemia lasting 30 seconds (clamping of the internal carotid artery). Clamping is done on the unaltered ICA, at the clamping site prior to performing CEA above the plaque termination point.
Eversion Carotid EndarterectomyProcedure or surgery
Also called eCEA
Standard Eversion Carotid Endarterectomy
| Study group | Role | What they receive |
|---|---|---|
| Ischemic postconditioning group | Experimental | Patients with ischemic postconditioning (IPCT) performed after standard eversion carotid endarterectomy (eCEA) Receives: Procedure: Ischemic postconditioning in carotid surgery |
| Control | Active comparator | Patients with standard eversion carotid endarterectomy (eCEA) performed with no ischemic postconditioning (IPCT) Receives: Procedure: Eversion Carotid Endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with perioperative stroke
Measured: During and 30 days after surgery
Number of Participants with perioperative death
Measured: During and 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Sep 2023
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
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 Ischemic PostconditioningStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Cardiovascular Diseases Dedinje
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nenad Ilijevski, PhD, Principal investigator, Institute for Cardiovascular Diseases Dedinje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359756
- Sponsor's protocol ID
- BRAIN-SAVE1
- Acronym
- BRAIN-SAVE
- Status last verified
- Mar 2026
- First submitted
- 6 Apr 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ilijevski N, Atanasijevic I, Lozuk B, Gajin P, Matic P, Babic S, Sagic D, Unic-Stojanovic D, Tanaskovic S. Direct Ischemic Postconditioning After Carotid Endarterectomy in the Prevention of Postoperative Cerebral Ischemic Complications-Observational Case-Control Study. J Cardiovasc Pharmacol Ther. 2022 Jan-Dec;27:10742484221137489. doi: 10.1177/10742484221137489.
PubMed 36377766
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Postconditioning in Prevention of Brain Damage After Carotid Surgery - a Clinical Trial for Vascular Evaluation
- ClinicalTrials.gov ID
- NCT06359756
- Acronym / sponsor ID
- BRAIN-SAVE / BRAIN-SAVE1
- Keywords
- Ischemic Postconditioning, Carotid Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institute for Cardiovascular Diseases DedinjeUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 11 Apr 2024 (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.
Analyzing changes in cerebral oximetry, transcranial Doppler and biomarkers of neuronal ischemic injury and blood-brain barrier integrity assessing the safety and efficacy of ischemic postconditioning in carotid surgery (IPCT).
Detailed description
Eversion carotid endarterectomy (eCEA) has proven effective in preventing ischemic brain damage resulting from atherosclerotic disease in the extracranial segment of the carotid arteries. Over time, advancements in surgical techniques have led to a reduction in the incidence of perioperative stroke. To better understand the concept of stroke complications following CEA, a clear distinction between intraprocedural and postprocedural strokes is necessary. Periprocedural strokes are attributed to hypoperfusion or embolization from the site of endarterectomy, while defined causes of postprocedural strokes include local carotid artery thrombosis or cerebral hyperperfusion syndrome (CHS).
CHS, occurring in 1-3% of cases, is a potentially catastrophic event following eCEA, primarily resulting from impaired autoregulation mechanisms and post-revascularization changes in cerebral hemodynamics. Patients with significant carotid stenosis are particularly vulnerable to CHS due to prolonged cerebral hypoperfusion, where collateral circulation serves as a protective mechanism. Another pathway leading to CHS involves increased free radical concentrations, damaging the blood-brain barrier. Identified risk factors for CHS development include advanced age, prior ischemic cerebrovascular events, and contralateral stenosis > 70%.
Various methods for predicting CHS development and collateral circulation insufficiency include cerebral oximetry, transcranial Doppler sonography, perfusion computed tomography, and quantitative magnetic resonance imaging. Cerebral oximetry, with real-time detection of cerebral oxygenated hemoglobin saturation, exhibits promising sensitivity and specificity in predicting CHS occurrence.
Analyzing changes in biomarkers of neuronal ischemic injury and blood-brain barrier integrity offers insight into CHS pathophysiology and indirectly assesses the safety and efficacy of ischemic postconditioning of the carotid artery (IPCT) in high-risk patients. IPCT, shown to have a protective effect in animal models, recently demonstrated encouraging results in human trials.
Utilizing intraoperative neuromonitoring with cerebral oximetry and transcranial Doppler enables real-time monitoring of cerebral oxygenated hemoglobin saturation and flow characteristics during and after IPCT, validating its protective effect and safety in high-risk CHS scenarios.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic postconditioning group | Experimental | Procedure: Ischemic postconditioning in carotid surgeryPatients with ischemic postconditioning (IPCT) performed after standard eversion carotid endarterectomy (eCEA) |
| Control | Active comparator | Procedure: Eversion Carotid EndarterectomyPatients with standard eversion carotid endarterectomy (eCEA) performed with no ischemic postconditioning (IPCT) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- unilateral carotid artery stenosis >90%
- bilateral stenosis >80%
- unilateral stenosis >80% with contralateral occlusion/subocclusion
Key exclusion criteria (6 listed)
- urgent carotid endarterectomy
- carotid restenosis
- "major surgery" in the last 6 months
- malignant diseases
- previous brain trauma or surgery
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 |
|---|---|---|
| Ischemic postconditioning in carotid surgeryAlso: IPCTAfter the initial declamping of the carotid artery the procedure is performed with 6 cycles of reperfusion of 30 seconds each (clamping of the internal carotid artery) which are successively followed by 6 cycles of ischemia lasting 30 seconds (clamping of the internal carotid artery). Clamping is done on the unaltered ICA, at the clamping site prior to performing CEA above the plaque termination point. | Procedure or surgery | Ischemic postconditioning group |
| Eversion Carotid EndarterectomyAlso: eCEAStandard Eversion Carotid Endarterectomy | Procedure or surgery | Control |
Primary outcome
Number of Participants with perioperative stroke
Time frame: During and 30 days after surgery
Number of Participants with perioperative death
Time frame: During and 30 days after surgery
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 27 Mar 2026.
- Background: PubMed 36377766Ilijevski N, Atanasijevic I, Lozuk B, Gajin P, Matic P, Babic S, Sagic D, Unic-Stojanovic D, Tanaskovic S. Direct Ischemic Postconditioning After Carotid Endarterectomy in the Prevention of Postoperative Cerebral Ischemic Complications-Observational Case-Control Study. J Cardiovasc Pharmacol Ther. 2022 Jan-Dec;27:10742484221137489. doi: 10.1177/10742484221137489.
- Individual participant dataSharing planned: No
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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.
Nenad Ilijevski, PhD principal investigator
Institute for Cardiovascular Diseases Dedinje
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic postconditioning in carotid surgery and Eversion Carotid Endarterectomy in people with Ischemic Postconditioning and Carotid Surgery, run by Institute for Cardiovascular Diseases Dedinje at 1 site in Serbia.
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 3 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 27 Mar 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 Serbia. 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?
Number of Participants with perioperative stroke (time frame: During and 30 days after surgery). The study lists 2 primary outcomes in all. 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 NCT06359756, 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 27 Mar 2026.