Spinal Cord IschemiaSCI-AORTANCT07896564
Risk Factors for Spinal Cord Injury After Minimally Invasive Aortic Repair
An observational study of Spinal Cord Ischemia, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to identify factors linked to spinal cord injury after aortic repair. The aorta is the body's main artery. The repairs studied use a fabric-covered tube, called a stent graft, placed inside the aorta. Sometimes, blood flow to the spinal cord is reduced after these procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Ischemia
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to Oct 2029
- Phase
- Observational
- 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
Study population: Adults aged 18 years or older who underwent TEVAR, bTEVAR, FEVAR, or BEVAR at Assiut University Hospital during the defined study period. All patients meeting the inclusion and exclusion criteria will be included. Eligible patients will be identified retrospectively from hospital clinical, procedural, imaging, and follow-up records. The population includes patients with and without postoperative spinal cord ischemia.
Who may be able to join
- Age 18 years or older at the time of the endovascular aortic intervention.
- Treatment with thoracic endovascular aortic repair (TEVAR), branched thoracic endovascular aortic repair (bTEVAR), fenestrated endovascular aortic repair (FEVAR), or branched endovascular aortic repair (BEVAR).
Who cannot join
- Previous or concomitant open aortic procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Medicine , Assiut University
Asyut, Asyut Governorate, 71111
Kareem Ayman Shaamash, Master of Science, +201067838388, kareemshamaash@gmail.com
About this study
Official title: Predictors of Spinal Cord Ischemia After Endovascular Aortic Interventions
This study aims to identify factors linked to spinal cord injury after aortic repair. The aorta is the body's main artery. The repairs studied use a fabric-covered tube, called a stent graft, placed inside the aorta. Sometimes, blood flow to the spinal cord is reduced after these procedures. This is called spinal cord ischemia and can cause leg weakness or loss of feeling.
Researchers will review existing medical records and scans from adults aged 18 or older. They will compare patients who developed spinal cord ischemia with those who did not. They will examine patients' health, repair details, blood pressure during the procedure, medicines used, and blood vessels supplying the spinal cord.
Read more
The study will also describe when this complication develops, how it is treated, and how patients recover. It will assess survival and time spent in hospital. The findings may help identify patients at greater risk and inform future prevention strategies.
This study uses information collected during routine care. Patients will not need additional tests, scans, treatments, or visits.
Read the detailed description
This is a retrospective, single-center observational cohort study conducted in the vascular and endovascular surgery department of a tertiary university hospital. It will include patients treated with thoracic endovascular aortic repair (TEVAR), branched thoracic endovascular aortic repair (bTEVAR), fenestrated endovascular aortic repair (FEVAR), or branched endovascular aortic repair (BEVAR). All cases meeting the prespecified eligibility criteria will be included.
The study will estimate the incidence of postoperative spinal cord ischemia (SCI), assess factors associated with its development, and describe its clinical course, treatment, and subsequent outcomes. Particular attention will be given to exploratory associations involving intraoperative protamine administration, blood pressure maintenance, and spinal collateral circulation assessed on preoperative computed tomography angiography (CTA).
Data will be extracted retrospectively from prospectively maintained clinical, procedural, anesthesia, postoperative, imaging, and follow-up records. Prespecified candidate variables will include demographics, comorbidities, aortic pathology, prior procedures, procedural characteristics, spinal protection strategies, anticoagulation and protamine use, intraoperative blood pressure, relevant laboratory parameters, and CTA-based spinal collateral anatomy. The final variable set will depend on data availability.
Patients will be classified according to whether they develop SCI within 30 days of the intervention. SCI will be defined as a new lower limb motor and/or sensory deficit attributed to spinal cord ischemia after other documented causes have been excluded. The timing and severity of neurological deficits, treatments provided, and recovery at discharge and during recorded follow-up will be characterized.
Patients with and without SCI will be compared using appropriate descriptive statistics and univariable tests. Multivariable logistic regression will assess adjusted associations with SCI, with model complexity limited by the number of SCI events. Survival will be evaluated using Kaplan-Meier analysis and, where feasible, Cox regression. Missing data will be assessed and handled according to their extent and pattern. A p-value below 0.05 will be considered statistically significant.
The study uses records generated during routine care, with no additional treatment, examination, imaging, or follow-up visits. No study-specific patient contact is planned. Each patient will be assigned a study code, and access to records will be restricted to authorized study personnel. Individual consent requirements, including any waiver of consent, will be determined by the institutional review board.
- Conditions
- Spinal Cord Ischemia
- Keywords
- Endovascular Aortic Repair, Risk Factors, Spinal Collateral Circulation
- Medical subject headings
- Spinal Cord Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Endovascular Aortic Repair | Adults aged 18 years or older who underwent thoracic endovascular aortic repair (TEVAR), branched thoracic endovascular aortic repair (bTEVAR), fenestrated endovascular aortic repair (FEVAR), or branched endovascular aortic repair (BEVAR) at Assiut University Hospital during the defined study period. The cohort will include all eligible patients, both with and without postoperative spinal cord ischemia (SCI). Existing clinical, procedural, anesthesia, imaging, and follow-up records will be reviewed retrospectively to assess SCI occurrence, associated risk factors, treatment, neurological recovery, and survival. All aortic procedures were performed as part of routine clinical care. No additional intervention will be assigned for this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Spinal Cord Ischemia
Percentage of included patients who develop postoperative spinal cord ischemia (SCI), defined as a new lower limb motor and/or sensory deficit attributed to spinal cord ischemia after other documented causes have been excluded. SCI occurrence will be determined through retrospective review of clinical and follow-up records.
Measured: Within 30 days after the endovascular aortic intervention.
Secondary outcomes (6)
Neurological Recovery at Hospital Discharge
Percentage of surviving patients with SCI whose SCI-related motor and/or sensory deficit has completely resolved at hospital discharge. Persistence of any SCI-related neurological deficit will also be recorded.
Measured: At discharge from the index hospitalization, assessed up to 90 days after the intervention.
Time to Spinal Cord Ischemia Onset
Time in days from the endovascular aortic intervention to the first documented SCI-related neurological deficit among patients who develop SCI
Measured: From the intervention through postoperative day 30.
Neurological Deficit Severity at SCI Onset
Number and percentage of patients with SCI classified by the documented initial neurological deficit, including partial or complete loss of lower limb movement and sensory impairment.
Measured: At the first documented SCI assessment, within 30 days after the intervention.
In-Hospital All-Cause Mortality
Percentage of included patients who die from any cause after the endovascular aortic intervention and before discharge from the index hospitalization.
Measured: From the intervention until discharge or in-hospital death, assessed up to 90 days.
30-Day All-Cause Mortality
Percentage of included patients who die from any cause within 30 days after the endovascular aortic intervention, whether during hospitalization or after discharge.
Measured: Within 30 days after the intervention.
Overall Survival
Time in months from the endovascular aortic intervention to death from any cause. Patients without a documented death will be censored at the last date they are known to be alive or the end of the observation window.
Measured: From the intervention to death or censoring, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord IschemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Ayman Hussien Shaamash, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896564
- Sponsor's protocol ID
- AST-KASH-SCI
- Acronym
- SCI-AORTA
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Spinal Cord Ischemia After Endovascular Aortic Interventions
- ClinicalTrials.gov ID
- NCT07896564
- Acronym / sponsor ID
- SCI-AORTA / AST-KASH-SCI
- Conditions
- Spinal Cord Ischemia
- Keywords
- Endovascular Aortic Repair, Risk Factors, Spinal Collateral Circulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 27 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.
This study aims to identify factors linked to spinal cord injury after aortic repair. The aorta is the body's main artery. The repairs studied use a fabric-covered tube, called a stent graft, placed inside the aorta. Sometimes, blood flow to the spinal cord is reduced after these procedures. This is called spinal cord ischemia and can cause leg weakness or loss of feeling.
Researchers will review existing medical records and scans from adults aged 18 or older. They will compare patients who developed spinal cord ischemia with those who did not. They will examine patients' health, repair details, blood pressure during the procedure, medicines used, and blood vessels supplying the spinal cord.
The study will also describe when this complication develops, how it is treated, and how patients recover. It will assess survival and time spent in hospital. The findings may help identify patients at greater risk and inform future prevention strategies.
This study uses information collected during routine care. Patients will not need additional tests, scans, treatments, or visits.
Detailed description
This is a retrospective, single-center observational cohort study conducted in the vascular and endovascular surgery department of a tertiary university hospital. It will include patients treated with thoracic endovascular aortic repair (TEVAR), branched thoracic endovascular aortic repair (bTEVAR), fenestrated endovascular aortic repair (FEVAR), or branched endovascular aortic repair (BEVAR). All cases meeting the prespecified eligibility criteria will be included.
The study will estimate the incidence of postoperative spinal cord ischemia (SCI), assess factors associated with its development, and describe its clinical course, treatment, and subsequent outcomes. Particular attention will be given to exploratory associations involving intraoperative protamine administration, blood pressure maintenance, and spinal collateral circulation assessed on preoperative computed tomography angiography (CTA).
Data will be extracted retrospectively from prospectively maintained clinical, procedural, anesthesia, postoperative, imaging, and follow-up records. Prespecified candidate variables will include demographics, comorbidities, aortic pathology, prior procedures, procedural characteristics, spinal protection strategies, anticoagulation and protamine use, intraoperative blood pressure, relevant laboratory parameters, and CTA-based spinal collateral anatomy. The final variable set will depend on data availability.
Patients will be classified according to whether they develop SCI within 30 days of the intervention. SCI will be defined as a new lower limb motor and/or sensory deficit attributed to spinal cord ischemia after other documented causes have been excluded. The timing and severity of neurological deficits, treatments provided, and recovery at discharge and during recorded follow-up will be characterized.
Patients with and without SCI will be compared using appropriate descriptive statistics and univariable tests. Multivariable logistic regression will assess adjusted associations with SCI, with model complexity limited by the number of SCI events. Survival will be evaluated using Kaplan-Meier analysis and, where feasible, Cox regression. Missing data will be assessed and handled according to their extent and pattern. A p-value below 0.05 will be considered statistically significant.
The study uses records generated during routine care, with no additional treatment, examination, imaging, or follow-up visits. No study-specific patient contact is planned. Each patient will be assigned a study code, and access to records will be restricted to authorized study personnel. Individual consent requirements, including any waiver of consent, will be determined by the institutional review board.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Endovascular Aortic Repair | – | –Adults aged 18 years or older who underwent thoracic endovascular aortic repair (TEVAR), branched thoracic endovascular aortic repair (bTEVAR), fenestrated endovascular aortic repair (FEVAR), or branched endovascular aortic repair (BEVAR) at Assiut University Hospital during the defined study period. The cohort will include all eligible patients, both with and without postoperative spinal cord ischemia (SCI). Existing clinical, procedural, anesthesia, imaging, and follow-up records will be reviewed retrospectively to assess SCI occurrence, associated risk factors, treatment, neurological recovery, and survival. All aortic procedures were performed as part of routine clinical care. No additional intervention will be assigned for this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older who underwent TEVAR, bTEVAR, FEVAR, or BEVAR at Assiut University Hospital during the defined study period. All patients meeting the inclusion and exclusion criteria will be included. Eligible patients will be identified retrospectively from hospital clinical, procedural, imaging, and follow-up records. The population includes patients with and without postoperative spinal cord ischemia.
Key inclusion criteria (2 listed)
- Age 18 years or older at the time of the endovascular aortic intervention.
- Treatment with thoracic endovascular aortic repair (TEVAR), branched thoracic endovascular aortic repair (bTEVAR), fenestrated endovascular aortic repair (FEVAR), or branched endovascular aortic repair (BEVAR).
Key exclusion criteria (1 listed)
- Previous or concomitant open aortic procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Postoperative Spinal Cord Ischemia
Time frame: Within 30 days after the endovascular aortic intervention.
Percentage of included patients who develop postoperative spinal cord ischemia (SCI), defined as a new lower limb motor and/or sensory deficit attributed to spinal cord ischemia after other documented causes have been excluded. SCI occurrence will be determined through retrospective review of clinical and follow-up records.
6 secondary outcomes
Neurological Recovery at Hospital Discharge
Time frame: At discharge from the index hospitalization, assessed up to 90 days after the intervention.
Time to Spinal Cord Ischemia Onset
Time frame: From the intervention through postoperative day 30.
Neurological Deficit Severity at SCI Onset
Time frame: At the first documented SCI assessment, within 30 days after the intervention.
In-Hospital All-Cause Mortality
Time frame: From the intervention until discharge or in-hospital death, assessed up to 90 days.
30-Day All-Cause Mortality
Time frame: Within 30 days after the intervention.
Overall Survival
Time frame: From the intervention to death or censoring, assessed up to 60 months.
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 27 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Ischemia, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 27 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 Egypt. 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?
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 Kareem Shaamash, Master of Science (+201067838388, kareemshaamash@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Spinal Cord Ischemia (time frame: Within 30 days after the endovascular aortic intervention.). 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 27 Oct 2026.