Trial Outcomes & Findings for Selective Versus Routine Shunting in Carotid Endarterectomy Patients (NCT NCT00967486)

Results Overview

perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction \[MI\], or asymptomatic carotid thrombosis or congestive heart failure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

200 participants

Primary outcome timeframe

Within 30 days of enrollment

Results posted on

2013-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	Routine Shunt Routine method of CEA	Selective Shunt Selective method if CEA with based Systolic pressure 40 mmHg
Overall Study STARTED	98	102
Overall Study COMPLETED	98	102
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Selective Versus Routine Shunting in Carotid Endarterectomy Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Routine Shunt n=98 Participants routine methods of CEA	Selective Shunt n=102 Participants Selective method if CEA with based Systolic pressure 40 mmHg	Total n=200 Participants Total of all reporting groups
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants	44 Participants n=7 Participants	82 Participants n=5 Participants
Age, Categorical >=65 years	60 Participants n=5 Participants	58 Participants n=7 Participants	118 Participants n=5 Participants
Age Continuous	68.78 years STANDARD_DEVIATION 9.08 • n=5 Participants	67.29 years STANDARD_DEVIATION 9.81 • n=7 Participants	68.02 years STANDARD_DEVIATION 9.46 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	53 Participants n=7 Participants	103 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	49 Participants n=7 Participants	97 Participants n=5 Participants
Region of Enrollment United States	98 participants n=5 Participants	102 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Routine Shunt n=98 Participants routine methods of CEA	Selective Shunt n=102 Participants Selective method if CEA with based Systolic pressure 40 mmHg
Overall Perioperative Complications Between Selective vs. Routine Shunting.	7 Participants	8 Participants

Adverse Events

Routine Shunt

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Selective Shunt

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ali Fawazi AbuRahma MD

Vascular center of excellence (CAMC medical staff-with admitting privileges)

Phone: 304-388-9973

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place