Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting
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ClinicalTrials.gov Identifier: NCT01414387 |
Recruitment Status
:
Terminated
(Therapy for carotid disease has recently changed. Carotid stenting is now restricted to high risk patients that are not eligible for the study.)
First Posted
: August 11, 2011
Last Update Posted
: August 2, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carotid Artery Disease Stroke | Procedure: Carotid filter Procedure: Carotid reversal of flow | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting |
Actual Study Start Date : | October 2011 |
Actual Primary Completion Date : | February 12, 2016 |
Actual Study Completion Date : | February 12, 2016 |
Arm | Intervention/treatment |
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Active Comparator: Carotid filter
For this intervention group, patients will receive FDA-approved filter devices for cerebral embolic protection during carotid artery stenting intervention.
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Procedure: Carotid filter
Patients randomized to this group will receive filter devices to prevent cerebral embolization during carotid stenting, assessed by intraoperative transcranial Doppler and postoperative cerebral DW-MRI. The filter used for this trial is the RX accunet embolic protection system manufactured by abbott. |
Active Comparator: Carotid reversal of flow
For this intervention group, patients will receive reversal of flow with the FDA-approved Gore Neuroprotection System for cerebral protection during carotid artery stenting.
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Procedure: Carotid reversal of flow
On the flow reversal arm two type of devices will be used. The first is the Gore flow reversal system, manufactured by LW Gore and the second device is the IVANTEC MoMa Ultra Embolic protection device, manufatured by IVANTEC.
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- Cerebral embolization [ Time Frame: Within 24 hours post carotid artery stenting ]Number of cerebral macro and microembolic events assessed as the number of new ipsilateral brain lesions detected by brain diffusion-weighted magnetic resonance imaging within 24 hours post carotid artery stenting and number of intraoperative microembolic signals detected by transcranial Doppler in the middle cerebral artery ipsilateral to the procedure during carotid artery stenting.
- Any Stroke, TIA, MI or death [ Time Frame: Within 30 days after carotid artery stenting ]Occurrence of any stroke, transient ischemic attack (TIA), myocardial infarction, or death within 30 days after carotid artery stenting.
- Technical success of carotid artery stenting [ Time Frame: 4 weeks. ]
- Stent thrombosis [ Time Frame: within 30 days post procedure ]Thrombosis of carotid artery stent implanted during the index procedure, assessed within 30 days after procedure

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414387
United States, Texas | |
Dallas VA Medical Center | |
Dallas, Texas, United States, 75216 |
Principal Investigator: | Carlos H Timaran, MD | Dallas VA Medical Center |
Responsible Party: | Carlos H. Timaran, MD, Dallas VA Medical Center |
ClinicalTrials.gov Identifier: | NCT01414387 History of Changes |
Other Study ID Numbers: |
11GRNT7960035 |
First Posted: | August 11, 2011 Key Record Dates |
Last Update Posted: | August 2, 2017 |
Last Verified: | July 2017 |
Keywords provided by Carlos H. Timaran, Dallas VA Medical Center:
carotid stenosis cerebral embolization stents stroke |
Additional relevant MeSH terms:
Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |