Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting

NCT01414387 | Terminated

• 1 other identifier: 11GRNT7960035
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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 protect the brain from particles(emboli) that may break off when the narrowing or blockage is cleared during the angioplasty and stenting procedure. Although filters are most frequently used, protection systems consisting of balloons and flow reversal are also available for cerebral embolic protection. However, there is little information about the effectiveness of filters compared with balloons and flow reversal for prevention of embolization during CAS. The aim of our study is to address this major problem. Our study was designed to answer two specific questions: First, the study will investigate whether balloon-based protection systems are more effective than filters in reducing the amount of particles that break off and travel to the brain during CAS. For this purpose two imaging techniques will be used: magnetic resonance imaging of the brain (MRI), and transcranial doppler (detection of microparticles in the small brain vessels using ultrasound). Second, it will be investigated whether the use of balloon-based protection devices are more effective than filters for prevention of stroke, heart attacks, and death after carotid stenting. The results of the study will provide important information to find out the best way to protect the brain from plaque fragments that may break off during CAS.

Conditions

Carotid Artery Disease; Stroke

Keywords

carotid stenosis; cerebral embolization; stents; stroke

Outcome Measures

Primary Outcomes (1)

• Cerebral embolization

  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.

  Within 24 hours post carotid artery stenting

Secondary Outcomes (3)

• Any Stroke, TIA, MI or death

  Within 30 days after carotid artery stenting

• Technical success of carotid artery stenting

  4 weeks.

• Stent thrombosis

  within 30 days post procedure

Study Arms (2)

Carotid filter

ACTIVE COMPARATOR

For this intervention group, patients will receive FDA-approved filter devices for cerebral embolic protection during carotid artery stenting intervention.

Procedure: Carotid filter

Carotid reversal of flow

ACTIVE COMPARATOR

For this intervention group, patients will receive reversal of flow with the FDA-approved Gore Neuroprotection System for cerebral protection during carotid artery stenting.

Procedure: Carotid reversal of flow

Interventions

Carotid filter PROCEDURE

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.

Carotid filter

Carotid reversal of flow PROCEDURE

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.

Carotid reversal of flow

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dallas VA Medical Center: lead
• American Heart Association: collaborator

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Carotid Artery Diseases; Stroke; Carotid Stenosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases

Study Officials

• Carlos H Timaran, MD

  Dallas VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 11, 2011
• Study Start: October 1, 2011
• Primary Completion: February 12, 2016
• Study Completion: February 12, 2016
• Last Updated: August 2, 2017

Record last verified: 2017-07

Locations

US (1)