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CompletedNCT06359756BRAIN-SAVEUpdated Mar 27, 2026

Ischemic Postconditioning in Carotid Surgery

An interventional study of Ischemic postconditioning in carotid surgery and Eversion Carotid Endarterectomy in Ischemic Postconditioning, Carotid Surgery and Stroke, sponsored by Institute for Cardiovascular Diseases Dedinje. Completed at 1 site in Serbia. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Institute for Cardiovascular Diseases Dedinje · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Sep 2023, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Ischemic Postconditioning
  • Carotid Surgery
  • Stroke
  • Carotid Artery Diseases

Keywords

  • Ischemic Postconditioning
  • Carotid Surgery
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Institute for Cardiovascular Diseases Dedinje is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • unilateral carotid artery stenosis >90%
  • bilateral stenosis >80%
  • unilateral stenosis >80% with contralateral occlusion/subocclusion

Exclusion criteria

Exclusion Criteria:

  • urgent carotid endarterectomy
  • carotid restenosis
  • "major surgery" in the last 6 months
  • malignant diseases
  • previous brain trauma or surgery
  • epilepsy
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Ischemic postconditioning group

    Patients with ischemic postconditioning (IPCT) performed after standard eversion carotid endarterectomy (eCEA)

    Procedure: Ischemic postconditioning in carotid surgery

  • Active comparator
    Control

    Patients with standard eversion carotid endarterectomy (eCEA) performed with no ischemic postconditioning (IPCT)

    Procedure: Eversion Carotid Endarterectomy

Interventions

  • ProcedureIschemic postconditioning in carotid surgery

    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.

    Also known as: IPCT

  • ProcedureEversion Carotid Endarterectomy

    Standard Eversion Carotid Endarterectomy

    Also known as: eCEA

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What researchers measure

Primary outcomes

  1. Number of Participants with perioperative stroke

    Time frame: During and 30 days after surgery

  2. Number of Participants with perioperative death

    Time frame: During and 30 days after surgery

07

Study locations

1 site
  • Institute for Cardiovascular Diseases Dedinje
    Belgrade, 11000, Serbia
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06359756
Lead sponsor
Institute for Cardiovascular Diseases Dedinje
Responsible party
Sponsor
First posted
Apr 11, 2024
Start date
Sep 1, 2023
Primary completion
Jan 1, 2026
Completion
Jan 1, 2026
Last update
Mar 27, 2026

Study contacts

Nenad Ilijevski, PhD
principal investigator · Institute for Cardiovascular Diseases Dedinje

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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