Carotid Artery DiseaseNCT01414387
Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting
A study testing Carotid filter and Carotid reversal of flow in people with Carotid Artery Disease and Stroke, run by Dallas VA Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Disease, Stroke
- What is being tested?
- Carotid filter and Carotid reversal of flow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to 12 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 neurological events related to stent thrombosis during the procedure, subjects should be provided antiplatelet therapy for a minimum of 48 to 72 hours prior to the procedure, to include: 1) Aspirin 325 mg daily and 2) Clopidogrel (Plavix®) 75 mg twice daily OR Ticlopidine (Ticlid®) 250 mg twice daily
A protracted dose of premedication may be substituted by administering a loading dose of antiplatelet therapy at least 4 hours prior to the carotid intervention on the day of the procedure, to include: 1) Aspirin A 650 mg loading dose of aspirin, provided that it is not enteric coated or extended release, and 2) Clopidogrel (Plavix ®) 450 mg.
Procedure: Patients will undergo CAS with FDA-approved carotid stents under embolic protection with the Accunet device or the Gore NPS. All CAS procedures will be performed through retrograde access from the common femoral artery. CAS procedures will be performed using a fixed angiographic unit (Allura Xper FD20, Philips, Bothell, WA). Procedural details and CAS protocols will follow techniques described in detail before.14 The procedure will be performed under local anesthesia with minimal sedation to facilitate continuous neurological evaluation. Baseline angiographic studies will be performed concurrently with the CAS procedure. The diagnostic angiography will be reviewed to ensure that the patient does not meet any applicable angiographic exclusion criteria. Once this has been determined, randomization will be performed. The Accunet filter or the Gore NPS will be used according to the instructions for use. Ultrasound-guided access to the ipsilateral or contralateral femoral vein will be obtained if the patient is randomized to CAS with the Gore NPS. Neurological monitoring of the subject's level of awareness will be evaluated every 5 to 10 minutes during the CAS procedure. Patients deemed ineligible by angiographic criteria will be considered screen failures and will be excluded from the study. These patients may receive further treatment outside of the study protocol according to usual practice and standard of care.
Transcranial Doppler Protocol: Transcranial Doppler signals, using a portable digital 2-MHz PMD/spectral TCD unit (PMD150, Spencer Technologies, Seattle, WA), will be recorded from bilateral middle cerebral arteries via transtemporal windows. Monitoring will be started in the operative room immediately before CAS and continued until the end of the case or for at least 15 minutes after removal of the neuroprotection system. A head frame will be used for ultrasound probe fixation and continuous flow assessment in M1 segment of the middle cerebral artery (MCA). Several TCD parameters will be recorded: MES counts and microemboli shower detection during the different steps of the procedure, initial MCA mean velocity, mean MCA velocity during CAS, and final mean MCA velocity. MES will be identified according to the recommended guidelines.31 Data will be stored on a hard disk using a coding system and will be analyzed off-line on a later day by readers who will be blinded to patient information.
Diffusion-weighted MRI exams: All patients will have DW-MRI scans of the brain obtained within 24 hours prior to CAS and 18 to 24 hours after CAS. Postprocedural DW-MRI studies will be compared to preprocedural studies to identify new procedure-related ischemic cerebral lesions.32, 33 DW-MRI will be obtained using standard head coils on 1.5 Tesla Siemens scanners (Siemens Avanto or Magnetom Sonata, Siemens, Erlangen, Germany). DW-MRI with echo-planar imaging sequence (B0 = 1000) and fluid-attenuated inversion recovery (FLAIR) images will be obtained in axial and coronal sections. The DW-MRI studies will then be evaluated by neuroradiologists blinded to the clinical status, the type of embolic protection and TCD data of the patients. On the postprocedural MRI, acute embolic lesions will be defined as focal hyperintense areas with restricted diffusion signal, which will be confirmed by apparent diffusion coefficient mapping to rule out artifacts. New postprocedural cerebral lesions consistent with microemboli will be recorded in terms of location and number for all DW-MRI exams performed.
- Conditions
- Carotid Artery Disease, Stroke
- Being tested
- Carotid filter, Carotid reversal of flow
- Keywords
- carotid stenosis, cerebral embolization, stents, stroke
- Medical subject headings
- Carotid Artery Diseases, Stroke, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid filterProcedure or surgery
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 reversal of flowProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Carotid filter | Active comparator | For this intervention group, patients will receive FDA-approved filter devices for cerebral embolic protection during carotid artery stenting intervention. Receives: 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. Receives: Procedure: Carotid reversal of flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours post carotid artery stenting
Secondary outcomes (3)
Any Stroke, TIA, MI or death
Occurrence of any stroke, transient ischemic attack (TIA), myocardial infarction, or death within 30 days after carotid artery stenting.
Measured: Within 30 days after carotid artery stenting
Technical success of carotid artery stenting
Measured: 4 weeks.
Stent thrombosis
Thrombosis of carotid artery stent implanted during the index procedure, assessed within 30 days after procedure
Measured: within 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startOct 2011
- Primary completion12 Feb 2016
- Study completion12 Feb 2016
Why it stopped: Therapy for carotid disease has recently changed. Carotid stenting is now restricted to high risk patients that are not eligible for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Carlos H. Timaran, Dallas VA Medical Center
- Investigators
- Carlos H Timaran, MD, Principal investigator, Dallas VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414387
- Sponsor's protocol ID
- 11GRNT7960035
- Status last verified
- Jul 2017
- First submitted
- 5 Aug 2011
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting
- ClinicalTrials.gov ID
- NCT01414387
- Acronym / sponsor ID
- 11GRNT7960035
- Conditions
- Carotid Artery Disease, Stroke
- Keywords
- carotid stenosis, cerebral embolization, stents, stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Therapy for carotid disease has recently changed. Carotid stenting is now restricted to high risk patients that are not eligible for the study.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- Collaborators
- American Heart Association
- Study start
- Oct 2011 (actual)
- Primary completion
- 12 Feb 2016 (actual)
- Study completion
- 12 Feb 2016 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 neurological events related to stent thrombosis during the procedure, subjects should be provided antiplatelet therapy for a minimum of 48 to 72 hours prior to the procedure, to include: 1) Aspirin 325 mg daily and 2) Clopidogrel (Plavix®) 75 mg twice daily OR Ticlopidine (Ticlid®) 250 mg twice daily
A protracted dose of premedication may be substituted by administering a loading dose of antiplatelet therapy at least 4 hours prior to the carotid intervention on the day of the procedure, to include: 1) Aspirin A 650 mg loading dose of aspirin, provided that it is not enteric coated or extended release, and 2) Clopidogrel (Plavix ®) 450 mg.
Procedure: Patients will undergo CAS with FDA-approved carotid stents under embolic protection with the Accunet device or the Gore NPS. All CAS procedures will be performed through retrograde access from the common femoral artery. CAS procedures will be performed using a fixed angiographic unit (Allura Xper FD20, Philips, Bothell, WA). Procedural details and CAS protocols will follow techniques described in detail before.14 The procedure will be performed under local anesthesia with minimal sedation to facilitate continuous neurological evaluation. Baseline angiographic studies will be performed concurrently with the CAS procedure. The diagnostic angiography will be reviewed to ensure that the patient does not meet any applicable angiographic exclusion criteria. Once this has been determined, randomization will be performed. The Accunet filter or the Gore NPS will be used according to the instructions for use. Ultrasound-guided access to the ipsilateral or contralateral femoral vein will be obtained if the patient is randomized to CAS with the Gore NPS. Neurological monitoring of the subject's level of awareness will be evaluated every 5 to 10 minutes during the CAS procedure. Patients deemed ineligible by angiographic criteria will be considered screen failures and will be excluded from the study. These patients may receive further treatment outside of the study protocol according to usual practice and standard of care.
Transcranial Doppler Protocol: Transcranial Doppler signals, using a portable digital 2-MHz PMD/spectral TCD unit (PMD150, Spencer Technologies, Seattle, WA), will be recorded from bilateral middle cerebral arteries via transtemporal windows. Monitoring will be started in the operative room immediately before CAS and continued until the end of the case or for at least 15 minutes after removal of the neuroprotection system. A head frame will be used for ultrasound probe fixation and continuous flow assessment in M1 segment of the middle cerebral artery (MCA). Several TCD parameters will be recorded: MES counts and microemboli shower detection during the different steps of the procedure, initial MCA mean velocity, mean MCA velocity during CAS, and final mean MCA velocity. MES will be identified according to the recommended guidelines.31 Data will be stored on a hard disk using a coding system and will be analyzed off-line on a later day by readers who will be blinded to patient information.
Diffusion-weighted MRI exams: All patients will have DW-MRI scans of the brain obtained within 24 hours prior to CAS and 18 to 24 hours after CAS. Postprocedural DW-MRI studies will be compared to preprocedural studies to identify new procedure-related ischemic cerebral lesions.32, 33 DW-MRI will be obtained using standard head coils on 1.5 Tesla Siemens scanners (Siemens Avanto or Magnetom Sonata, Siemens, Erlangen, Germany). DW-MRI with echo-planar imaging sequence (B0 = 1000) and fluid-attenuated inversion recovery (FLAIR) images will be obtained in axial and coronal sections. The DW-MRI studies will then be evaluated by neuroradiologists blinded to the clinical status, the type of embolic protection and TCD data of the patients. On the postprocedural MRI, acute embolic lesions will be defined as focal hyperintense areas with restricted diffusion signal, which will be confirmed by apparent diffusion coefficient mapping to rule out artifacts. New postprocedural cerebral lesions consistent with microemboli will be recorded in terms of location and number for all DW-MRI exams performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotid filter | Active comparator | Procedure: Carotid filterFor this intervention group, patients will receive FDA-approved filter devices for cerebral embolic protection during carotid artery stenting intervention. |
| Carotid reversal of flow | Active comparator | Procedure: Carotid reversal of flowFor this intervention group, patients will receive reversal of flow with the FDA-approved Gore Neuroprotection System for cerebral protection during carotid artery stenting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid filterPatients 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. | Procedure or surgery | Carotid filter |
| Carotid reversal of flowOn 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. | Procedure or surgery | Carotid reversal of flow |
Primary outcome
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.
3 secondary outcomes
Any Stroke, TIA, MI or death
Time frame: 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
Results and safety
The study was stopped early (reason given: Therapy for carotid disease has recently changed. Carotid stenting is now restricted to high risk patients that are not eligible for the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
Related trials for Carotid Artery Disease
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
Not yet recruitingObservational study
Common Carotid Artery-Renal Artery-Femoral Artery Survey for Hypertension
Hypertension, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos H Timaran, MD principal investigator
Dallas VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotid filter and Carotid reversal of flow in people with Carotid Artery Disease and Stroke, run by Dallas VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Therapy for carotid disease has recently changed. Carotid stenting is now restricted to high risk patients that are not eligible for the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral embolization (time frame: Within 24 hours post carotid artery stenting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017.