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OpenTrials
Completed

NCT Number: NCT00967486

Selective Versus Routine Shunting in Carotid Endarterectomy Patients

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

(Vascular Center of Excellence)

Charleston, West Virginia, 25304, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carotid endarterectomy with routine shount

Procedure

Carotid endarterectomy with selective shunt

Procedure

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

CAMC Health System

Other

Registry information

Official study title

Selective Shunting in Appropriately Selected Patients Undergoing Carotid Endarterectomy Based on Stump Pressure

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 28, 2009
Registry last updated
Oct 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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