Stenoses, Carotid ArteryNCT00967486
Selective Versus Routine Shunting in Carotid Endarterectomy Patients
A study testing Carotid endarterectomy with routine shount and Carotid endarterectomy with selective shunt in people with Stenoses, Carotid Artery, run by CAMC Health System at 1 site in United States.
Trial summary
The project involves prospectively randomizing patients to either routine carotid shunting or selective carotid shunting during Carotid endarterectomy (CEA) under general anesthesia (GA) to see the difference in post-op complications and occurence rates. Patients will be randomized to Routine shunt vs selective groups. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stenoses, Carotid Artery
- What is being tested?
- Carotid endarterectomy with routine shount and Carotid endarterectomy with selective shunt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a SP >= 50 mmHg will be randomized to receive a shunt or not receive a shunt.
Who cannot join
- Patients that will be excluded are those who present for a redo CEA, have had a coronary artery bypass graft (CABG), permanent stroke, and or a contralateral artery total occlusion of > 30%.
- Finally, consented patients with a stump pressure of <= 50 mm Hg will be excluded from the study and receive standard of care.
Trial locations and contacts
1 site in 1 country.
United States1 site
(Vascular Center of Excellence)
Charleston, West Virginia, 25304
About this study
Official title: Selective Shunting in Appropriately Selected Patients Undergoing Carotid Endarterectomy Based on Stump Pressure
The project involves prospectively randomizing patients to either routine carotid shunting or selective carotid shunting during Carotid endarterectomy (CEA) under general anesthesia (GA) to see the difference in post-op complications and occurence rates. Patients will be randomized to Routine shunt vs selective groups.
Read the detailed description
The significance extends to all surgeons who perform Carotid endarterectomy because of their desire to improve patient care by decreasing the overall perioperative complication rate of the procedure by selectively not shunting those patients who ideally do not require it and thus eliminating the attendant morbidity associated with it.
The hypothesis is that there will be no difference in patient outcomes (death, minor strokes, major strokes, transient ischemic attack (TIA)) for patients undergoing a Carotid endarterectomy with a SP of > 50 mm Hg using selective shunting.Patients will be randomized to Routine shunt vs selective groups. In Selective shunt, there will be subgroup analysis to measure % stenosis if the systolic pressure is < 40mmHg calling it as Shunt group. All patients in the study, irrespective of treatment group will be followed post-operatively from 24 hours to 30 days. The patient will be monitored and the following outcomes documented - death, minor stroke, major stroke, trans-ischemic attack (TIA).
- Conditions
- Stenoses, Carotid Artery
- Being tested
- Carotid endarterectomy with routine shount, Carotid endarterectomy with selective shunt
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid endarterectomy with routine shountProcedure or surgery
Carotid endarterectomy with selective shuntProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Routine Shunt | Active comparator | These patients are called routine as the routine method of carotid endarterectomy is used. Receives: Procedure: Carotid endarterectomy with routine shount |
| Selective Shunt | Active comparator | These patients are selectively used for shunting or not shunting based on systolic pressure < 40mmHg. This group is further used as subgroup analysis. Receives: Procedure: Carotid endarterectomy with selective shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Perioperative Complications Between Selective vs. Routine Shunting.
perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction [MI], or asymptomatic carotid thrombosis or congestive heart failure.
Measured: Within 30 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startDec 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stenoses, Carotid ArteryStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali F AbuRhama, M.D., Principal investigator, CAMC Medical Staff - with admitting privileges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967486
- Sponsor's protocol ID
- 06-11-1878
- Status last verified
- Aug 2013
- First submitted
- 27 Aug 2009
- Last updated
- 16 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Shunting in Appropriately Selected Patients Undergoing Carotid Endarterectomy Based on Stump Pressure
- ClinicalTrials.gov ID
- NCT00967486
- Acronym / sponsor ID
- 06-11-1878
- Conditions
- Stenoses, Carotid Artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Posted 24 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project involves prospectively randomizing patients to either routine carotid shunting or selective carotid shunting during Carotid endarterectomy (CEA) under general anesthesia (GA) to see the difference in post-op complications and occurence rates. Patients will be randomized to Routine shunt vs selective groups.
Detailed description
The significance extends to all surgeons who perform Carotid endarterectomy because of their desire to improve patient care by decreasing the overall perioperative complication rate of the procedure by selectively not shunting those patients who ideally do not require it and thus eliminating the attendant morbidity associated with it.
The hypothesis is that there will be no difference in patient outcomes (death, minor strokes, major strokes, transient ischemic attack (TIA)) for patients undergoing a Carotid endarterectomy with a SP of > 50 mm Hg using selective shunting.Patients will be randomized to Routine shunt vs selective groups. In Selective shunt, there will be subgroup analysis to measure % stenosis if the systolic pressure is < 40mmHg calling it as Shunt group. All patients in the study, irrespective of treatment group will be followed post-operatively from 24 hours to 30 days. The patient will be monitored and the following outcomes documented - death, minor stroke, major stroke, trans-ischemic attack (TIA).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Shunt | Active comparator | Procedure: Carotid endarterectomy with routine shountThese patients are called routine as the routine method of carotid endarterectomy is used. |
| Selective Shunt | Active comparator | Procedure: Carotid endarterectomy with selective shuntThese patients are selectively used for shunting or not shunting based on systolic pressure < 40mmHg. This group is further used as subgroup analysis. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a SP >= 50 mmHg will be randomized to receive a shunt or not receive a shunt.
Key exclusion criteria (2 listed)
- Patients that will be excluded are those who present for a redo CEA, have had a coronary artery bypass graft (CABG), permanent stroke, and or a contralateral artery total occlusion of > 30%.
- Finally, consented patients with a stump pressure of <= 50 mm Hg will be excluded from the study and receive standard of care.
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 |
|---|---|---|
| Carotid endarterectomy with routine shount | Procedure or surgery | Routine Shunt |
| Carotid endarterectomy with selective shunt | Procedure or surgery | Selective Shunt |
Primary outcome
Overall Perioperative Complications Between Selective vs. Routine Shunting.
Time frame: Within 30 days of enrollment
perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction [MI], or asymptomatic carotid thrombosis or congestive heart failure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ali F AbuRhama, M.D. principal investigator
CAMC Medical Staff - with admitting privileges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotid endarterectomy with routine shount and Carotid endarterectomy with selective shunt in people with Stenoses, Carotid Artery, run by CAMC Health System at 1 site in United States.
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 1 inclusion and 2 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 16 Sep 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 United States. 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?
Yes. Results are posted in the registry (first posted 24 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Perioperative Complications Between Selective vs. Routine Shunting. (time frame: Within 30 days of enrollment). 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 16 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.