MedDataX Logo

Selective Versus Routine Shunting in Carotid Endarterectomy Patients

NCT ID: NCT00967486

Last Updated: 2013-10-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stenoses, Carotid Artery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Routine Shunt

These patients are called routine as the routine method of carotid endarterectomy is used.

Group Type ACTIVE_COMPARATOR

Carotid endarterectomy with routine shount

Intervention Type PROCEDURE

Selective Shunt

These patients are selectively used for shunting or not shunting based on systolic pressure \< 40mmHg. This group is further used as subgroup analysis.

Group Type ACTIVE_COMPARATOR

Carotid endarterectomy with selective shunt

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Carotid endarterectomy with routine shount

Intervention Type PROCEDURE

Carotid endarterectomy with selective shunt

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CAMC Health System

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ali AbuRahma

Ali Fawzi AbuRahma MD, Vascular Center of Excellence(CAMC Medical Staff - with admitting privileges).

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ali F AbuRhama, M.D.

Role: PRINCIPAL_INVESTIGATOR

CAMC Medical Staff - with admitting privileges

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

(Vascular Center of Excellence)

Charleston, West Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

06-11-1878

Identifier Type: -

Identifier Source: org_study_id