An interventional study of Carotid endarterectomy with routine shount and Carotid endarterectomy with selective shunt in Stenoses, Carotid Artery, sponsored by CAMC Health System. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by CAMC Health System · Not applicable, Interventional, and Diagnostic
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.
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).
364 studies on the registry are indexed under Carotid Stenosis; 85 are open to participants now.
This study's enrollment of 200 is above the median of 103 across 189 interventional studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →CAMC Health System is the lead sponsor of 47 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
These patients are called routine as the routine method of carotid endarterectomy is used.
Procedure: Carotid endarterectomy with routine shount
These patients are selectively used for shunting or not shunting based on systolic pressure \< 40mmHg. This group is further used as subgroup analysis.
Procedure: Carotid endarterectomy with selective shunt
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.
Time frame: Within 30 days of enrollment
| Milestone | Routine Shunt | Selective Shunt |
|---|---|---|
| Started | 98 | 102 |
| Completed | 98 | 102 |
| Not completed | 0 | 0 |
perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction \[MI\], or asymptomatic carotid thrombosis or congestive heart failure.
| Participants | Routine Shunt | Selective Shunt |
|---|---|---|
| Overall Perioperative Complications Between Selective vs. Routine Shunting. | 7 | 8 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Routine Shunt | 0/98 (0%) | 0/98 (0%) | 0/98 (0%) |
| Selective Shunt | 1/102 (1%) | 1/102 (1%) | 0/102 (0%) |
| Event | Routine Shunt | Selective Shunt |
|---|---|---|
| StrokeNervous system disorders | — | 1/102 |
| Age, Customized(participants) | Routine Shunt | Selective Shunt | Total |
|---|---|---|---|
| Between 18 and 65 years | 38 | 44 | 82 |
| >=65 years | 60 | 58 | 118 |
| Age, Continuous(years) | Routine Shunt | Selective Shunt | Total |
|---|---|---|---|
| Mean | 68.78 ± 9.08 | 67.29 ± 9.81 | 68.02 ± 9.46 |
| Sex: Female, Male(Participants) | Routine Shunt | Selective Shunt | Total |
|---|---|---|---|
| Female | 50 | 53 | 103 |
| Male | 48 | 49 | 97 |
| Region of Enrollment(participants) | Routine Shunt | Selective Shunt | Total |
|---|---|---|---|
| United States | 98 | 102 | 200 |
The record gives a start of Dec 2006, a primary completion of Jun 2009 and a completion of Jun 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2013, 4 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
CAMC Health System