N/A
N=200
Selective Versus Routine Shunting in Carotid Endarterectomy Patients
Stenoses, Carotid Artery
Bottom Line
View on ClinicalTrials.gov: NCT00967486 ↗Enrolled (actual)
200
Serious AEs
—
Results posted
Oct 2013
Primary outcome: Primary: Overall Perioperative Complications Between Selective vs. Routine Shunting. — 7; 8 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Carotid endarterectomy with routine shount (Procedure); Carotid endarterectomy with selective shunt (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CAMC Health System
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Perioperative Complications Between Selective vs. Routine Shunting. |
7; 8 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Patients with a SP >= 50 mmHg will be randomized to receive a shunt or not receive a shunt.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00967486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.