Carotid Artery Occlusive DiseaseNCT02220595
A Comparison of Cognitive Function After Carotid Endarterectomy and Stenting
A study testing Carotid endarterectomy vs. carotid stenting in people with Carotid Artery Occlusive Disease, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This study compares cognitive function after carotid endarterectomy and stenting. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Carotid Artery Occlusive Disease
- What is being tested?
- Carotid endarterectomy vs. carotid stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jan 2014
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Carotid artery occlusive disease, asymptomatic greater than 80% with CTA or carotid duplex
Who cannot join
- Contraindication for carotid endarterectomy or stenting
Trial locations and contacts
1 site in 1 country.
About this study
This study compares cognitive function after carotid endarterectomy and stenting.
- Conditions
- Carotid Artery Occlusive Disease
- Being tested
- Carotid endarterectomy vs. carotid stenting
- Keywords
- Stenting, Endarterectomy, Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid endarterectomy vs. carotid stentingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Carotid stenting | Experimental | Carotid artery stenting for treatment of carotid artery stenosis Receives: Procedure: Carotid endarterectomy vs. carotid stenting |
| Carotid endarterectomy | Active comparator | Carotid artery endarterectomy for treatment of carotid artery stenosis Receives: Procedure: Carotid endarterectomy vs. carotid stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in RAVLT score
Measured: Six weeks
Secondary outcomes (17)
Cognitive tests for attention, memory, processing speed, mood, motor function, visual-spatial skills, executive functioning
Measured: Six weeks and six months
Cognitive tests of attention
Comparison in cognitive tests for attention between carotid endarterectomy and stenting
Measured: Six weeks
Cognitive tests for memory
Comparison in cognitive tests for memory between carotid endarterectomy and stenting
Measured: Six weeks
Cognitive tests for processing speed
Comparison in cognitive tests for processing speed between carotid endarterectomy and stenting
Measured: Six weeks
Cognitive tests of mood
Comparison in cognitive tests for mood between carotid endarterectomy and stenting
Measured: Six weeks
Tests of motor function
Comparison in cognitive tests for motor function between carotid endarterectomy and stenting
Measured: Six weeks
Cognitive tests of visual-spatial skills
Comparison in cognitive tests of visual-spatial skills between carotid endarterectomy and stenting
Measured: Six weeks
Cognitive tests of executive functioning
Comparison in cognitive tests for executive functioning between carotid endarterectomy and stenting
Measured: Six weeks
Cognitive tests of attention
Comparison in cognitive tests for attention between carotid endarterectomy and stenting
Measured: Six months
Cognitive tests of memory
Comparison in cognitive tests for memory between carotid endarterectomy and stenting
Measured: Six weeks
Cognitive tests of processing speed
Comparison in cognitive tests for processing speed between carotid endarterectomy and stenting
Measured: Six months
Cognitive tests of mood
Comparison in cognitive tests for mood between carotid endarterectomy and stenting
Measured: Six months
Tests of motor function
Comparison in cognitive tests for motor function between carotid endarterectomy and stenting
Measured: Six months
Cognitive tests of visual-spatial skills
Comparison in cognitive tests for visual-spatial skills between carotid endarterectomy and stenting
Measured: Six months
Cognitive tests of executive functioning
Comparison in cognitive tests for executive functioning between carotid endarterectomy and stenting
Measured: Six months
Difference in new ischemic infarcts in Diffusion - weighted MRI
Difference in new ischemic infarcts in Diffusion - weighted MRI
Measured: Six weeks
Difference in new ischemic infarcts in Diffusion - weighted MRI
Difference in new ischemic infarcts in Diffusion - weighted MRI
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startApr 2011
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panos Kougias, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220595
- Sponsor's protocol ID
- H - 22797
- Status last verified
- Aug 2014
- First submitted
- 8 Aug 2014
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Cognitive Function After Carotid Endarterectomy and Stenting
- ClinicalTrials.gov ID
- NCT02220595
- Acronym / sponsor ID
- H - 22797
- Conditions
- Carotid Artery Occlusive Disease
- Keywords
- Stenting, Endarterectomy, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 Aug 2014 (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.
This study compares cognitive function after carotid endarterectomy and stenting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotid stenting | Experimental | Procedure: Carotid endarterectomy vs. carotid stentingCarotid artery stenting for treatment of carotid artery stenosis |
| Carotid endarterectomy | Active comparator | Procedure: Carotid endarterectomy vs. carotid stentingCarotid artery endarterectomy for treatment of carotid artery stenosis |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Carotid artery occlusive disease, asymptomatic greater than 80% with CTA or carotid duplex
Key exclusion criteria (1 listed)
- Contraindication for carotid endarterectomy or stenting
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 endarterectomy vs. carotid stenting | Procedure or surgery | Carotid endarterectomy, Carotid stenting |
Primary outcome
Difference in RAVLT score
Time frame: Six weeks
17 secondary outcomes
Cognitive tests for attention, memory, processing speed, mood, motor function, visual-spatial skills, executive functioning
Time frame: Six weeks and six months
Cognitive tests of attention
Time frame: Six weeks
Cognitive tests for memory
Time frame: Six weeks
Cognitive tests for processing speed
Time frame: Six weeks
Cognitive tests of mood
Time frame: Six weeks
Tests of motor function
Time frame: Six weeks
Cognitive tests of visual-spatial skills
Time frame: Six weeks
Cognitive tests of executive functioning
Time frame: Six weeks
Cognitive tests of attention
Time frame: Six months
Cognitive tests of memory
Time frame: Six weeks
Cognitive tests of processing speed
Time frame: Six months
Cognitive tests of mood
Time frame: Six months
Tests of motor function
Time frame: Six months
Cognitive tests of visual-spatial skills
Time frame: Six months
Cognitive tests of executive functioning
Time frame: Six months
Difference in new ischemic infarcts in Diffusion - weighted MRI
Time frame: Six weeks
Difference in new ischemic infarcts in Diffusion - weighted MRI
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
Related trials for Carotid Artery Occlusive Disease
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
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
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Enrolling by invitationEarly Phase 1
Clinical Evaluation of the Safety and Efficacy of "Buyan Huan Wu Tang" Combined With Atorvastatin in the Treatment of Atypical Pneumonia
Moyamoya Disease
Not yet recruitingObservational study
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 endarterectomy vs. carotid stenting in people with Carotid Artery Occlusive Disease, run by Baylor College of Medicine 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Aug 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in RAVLT score (time frame: Six weeks). 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 20 Aug 2014.