Status:
TERMINATED
Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting
Lead Sponsor:
Dallas VA Medical Center
Collaborating Sponsors:
American Heart Association
Conditions:
Carotid Artery Disease
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Carotid artery stenting (CAS) with cerebral embolic protection is the preferred treatment for narrowing of the carotid arteries in patients at high risk for open surgery. Special devices are used to p...
Detailed Description
Description of Procedures to be performed Pre-Procedure Medication Regimen The standard of care premedication with antiplatelet therapy for CAS will be used for the study. To minimize the risk of neu...
Eligibility Criteria
Inclusion
- Patient is at least 18 years old;
- Patient is willing and capable of complying with the study protocol requirements, including the specified follow-up period;
- Patient is willing to provide written informed consent prior to enrollment in the study;
- Male, infertile female, or non-lactating female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7-days prior to study procedure;
- Patient is either symptomatic, i.e. with a history of TIAs or non-disabling stroke within 6 months of the procedure, with carotid stenosis ≥ 50%, or asymptomatic with carotid stenosis ≥ 80%, as diagnosed by angiography using NASCET methodology;4
- The target lesion is located in the internal carotid artery (ICA) and the reference vessel diameter, i.e. the common carotid artery (CCA) is \< 10 mm based on angiographic assessment.
Exclusion
- Acute evolving or recent stroke within 7 days of study evaluation;
- Cardiac embolism;
- Acute myocardial infarction less than 72 hours prior to the procedure;
- Major surgical procedure within 30 days preceding CAS;
- Major surgical procedure within 30 days after the index procedure;
- Prior major ipsilateral stroke with residual deficit or other neurologic conditions that may affect neurological assessments;
- Pregnancy or breastfeeding;
- Severe chronic renal insufficiency (serum creatinine is ≥ 2.5 mg/dL);
- Contraindication to study medications, including antiplatelet therapy;
- Prior sensitivity to contrast media that cannot adequately be controlled with pre-medication;
- Untreatable bleeding diathesis or hypercoagulable state or refusal to blood transfusions;
- History of uncontrolled pulmonary hypertension;
- Intracranial pathology;
- Patient unable or unwilling to undergo DW-MRI of the brain
- Patient without adequate transtemporal window for transcranial Doppler examination
- Other anatomic or co-morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
- Isolated ipsilateral hemisphere leading to subject intolerance to flow reversal;
- Anatomic conditions that preclude performance of carotid artery stenting.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2016
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01414387
Start Date
October 1 2011
End Date
February 12 2016
Last Update
August 2 2017
Active Locations (1)
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1
Dallas VA Medical Center
Dallas, Texas, United States, 75216