Carotid Artery Stenting for Cognitive Impairment

Overseen By ARVIN WALI, BA, MAS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Under 18, MRI incompatibility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Decreased blood flow to the brain can cause decreased cognitive function. Carotid disease can result in decreased blood flow to the brain. The investigators seek to assess this relationship prospectively through performing a battery of neurocognitive assessments, collection of serum markers of inflammation, and through neuroimaging at two points before intervention (2 months and 1 month before stenting) and at two points after intervention (1 month and 2 months after intervention). The goal is to provide prospective evidence to identify the extent to which carotid stenosis and hypoperfusion of the brain results in diminished neurocognitive performance, and see if serum biomarkers before and after stenting correlate with these findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is carotid artery stenting generally safe for humans?

Carotid artery stenting (CAS) is generally considered safe, with studies showing it as a viable alternative to surgery for treating narrowed carotid arteries, though it may have a risk of complications like stroke. Using cerebral protection devices during the procedure can reduce these risks, and many patients experience no major complications during follow-up. ^{1 2 3 4 5}

How does carotid artery stenting differ from other treatments for cognitive impairment?

Carotid artery stenting (CAS) is unique because it involves placing a small mesh tube in the carotid artery to improve blood flow, which may help with cognitive function by enhancing brain perfusion. Unlike other treatments, CAS directly addresses blood flow issues that can affect brain function, and it is an alternative to surgery for patients with carotid artery stenosis. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Carotid Artery Stenting for improving cognitive function?

Several studies have explored the impact of Carotid Artery Stenting (CAS) on cognitive function, with some indicating potential improvements in cognitive performance after the procedure. However, results are inconsistent, and factors like test design may influence outcomes, suggesting that while CAS might help some patients, its effects on cognition are not yet fully understood. ^{6 8 9 11 12}

Who Is on the Research Team?

David R Santiago-Dieppa, MD

Principal Investigator

UC San Diego

Alexander A Khalessi, MD

Principal Investigator

UC San Diego

Are You a Good Fit for This Trial?

This trial is for adults over 18 with carotid artery disease, evidenced by significant narrowing of the carotid arteries. It's not suitable for those under 18, lacking capacity to consent, needing emergency stenting, incompatible with MRI scans or intolerant to normal blood pressure levels.

Inclusion Criteria

My ultrasound shows I have significant narrowing in my carotid artery.

I am over 18 years old.

Exclusion Criteria

I need an urgent procedure for my carotid artery due to worsening symptoms.

I understand the risks and benefits of this study and can consent for myself.

I need a procedure to open my neck artery for reasons other than long-term narrowing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention Assessment

Cognitive testing and neuroimaging conducted at 2 months and 1 month before intervention

2 months

2 visits (in-person)

Intervention

Carotid artery stenting procedure

1 day

1 visit (in-person)

Post-intervention Assessment

Cognitive testing and neuroimaging conducted at 1 month and 2 months after intervention

2 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Carotid Artery Stenting

Trial Overview The study aims to understand how narrowed carotid arteries affect brain function. Participants will undergo neurocognitive tests and have their blood checked for inflammation markers before and after getting a procedure called Carotid Artery Stenting.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 3 Interventions

Patients, as outlined by NASCET criteria, will have between 50 symptomatic stenosis or 70% asymptomatic stenosis of the carotid artery. Patients, undergoing carotid artery stenting for carotid stenosis, will undergo cognitive testing at 2 time points after invention (1 month and 2 months). The two postoperative time points will serve as the intervention group.

Group II: Control Group Active Control 2 Interventions

Patients, as outlined by NASCET criteria, will have between 50 symptomatic stenosis or 70% asymptomatic stenosis of the carotid artery. Patients, undergoing carotid artery stenting for carotid stenosis, will undergo cognitive testing at 2 time points before intervention (1 months, and 2 months). The two preoperative time points will serve as the control group.

Carotid Artery Stenting is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Carotid Artery Stenting for:

• Symptomatic carotid stenosis ≥70%
• Asymptomatic carotid stenosis >60%
• Symptomatic carotid stenosis 50-69%

Approved in United States as Carotid Artery Stenting for:

• Symptomatic carotid stenosis ≥70%
• Asymptomatic carotid stenosis >60%
• Symptomatic carotid stenosis 50-69%

Approved in Canada as Carotid Artery Stenting for:

• Symptomatic carotid stenosis ≥70%
• Asymptomatic carotid stenosis >60%
• Symptomatic carotid stenosis 50-69%

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

In a study of 31 patients with severe carotid artery stenosis undergoing carotid artery stenting (CAS), those with symptomatic carotid stenosis showed significant improvements in cognitive function, particularly in visuospatial skills and overall cognitive scores, compared to control subjects after 3 months.

Patients with asymptomatic carotid stenosis did not show cognitive improvements post-CAS, indicating that the cognitive benefits of the procedure may be more pronounced in those experiencing symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of carotid artery stenting on cognitive function in patients with carotid artery stenosis: a prospective, 3-month-follow-up study. Yoon, BA., Sohn, SW., Cheon, SM., et al.[2020]

In a study of 72 patients undergoing carotid artery stenting (CAS), significant improvements were observed in verbal episodic memory three months post-procedure, while spatial memory showed deterioration.

By analyzing patients without extreme baseline cognitive performance (floor and ceiling effects), the study revealed that CAS can enhance global cognition and attention, particularly in patients with left-sided CAS, highlighting the importance of tailored cognitive assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ignoring floor and ceiling effects may underestimate the effect of carotid artery stenting on cognitive performance. Scherr, M., Kunz, A., Doll, A., et al.[2018]

In a study of 22 patients undergoing carotid angioplasty with stent placement (CAS), significant improvements in verbal memory were observed post-procedure, although some patients also experienced cognitive deterioration.

The presence of acute ischemic lesions detected by diffusion weighted imaging (DWI) did not correlate with cognitive changes, indicating that predicting individual neuropsychological outcomes after CAS remains challenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological sequelae of carotid angioplasty with stent placement: correlation with ischemic lesions in diffusion weighted imaging. Tiemann, L., Reidt, JH., Esposito, L., et al.[2022]

Carotid artery stenting (CAS) is associated with significant improvements in global cognition, memory, and attention/psychomotor speed in patients with carotid artery stenosis, based on a meta-analysis of 16 studies involving 626 patients.

However, CAS did not show any positive effects on executive function, language ability, or functional ability, indicating that while it may enhance certain cognitive domains, it does not lead to declines in cognitive function overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of carotid artery stenting on cognitive function in patients with extracranial carotid artery stenosis. Antonopoulos, CN., Kakisis, JD., Sfyroeras, GS., et al.[2015]

In a study of 31 Indian patients undergoing carotid artery stenting (CAS), there were no immediate or delayed complications, indicating a safe procedure.

CAS led to a significant improvement in cognitive function, particularly in memory and visuospatial abilities, as measured by the Addenbrooke's cognitive examination three months post-stenting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carotid Artery Stenting and Its Impact on Cognitive Function: A Prospective Observational Study. Gupta, AN., Bhatti, AA., Shah, MM., et al.[2020]

In a study of 224 patients undergoing carotid angioplasty and stenting (CAS), octogenarians (patients aged 80 and above) did not experience a higher risk of adverse events compared to younger patients, indicating that age alone should not exclude patients from this procedure.

Both groups had similar procedural success rates and hospital stays, with low rates of transient ischemic attacks and strokes, suggesting that CAS is a safe option for older patients when performed under appropriate conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Octogenarians are not at increased risk for periprocedural stroke following carotid artery stenting. Bacharach, JM., Slovut, DP., Ricotta, J., et al.[2016]

Carotid angioplasty and stenting (CAS) has a slightly higher risk of periprocedural strokes compared to carotid endarterectomy (CEA), particularly in patients over 70 and those who have recently experienced symptoms, but it has a lower incidence of cardiac events and cranial nerve palsies.

Both CAS and CEA are equally effective in preventing future strokes, and while CAS is a valid alternative for symptomatic patients, in asymptomatic patients, modern medical therapy may be as effective as either procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carotid Angioplasty and Stenting and Embolic Protection. Giordan, E., Lanzino, G.[2018]

In a study of 101 high surgical risk patients undergoing carotid artery stenting (CAS), the procedure demonstrated a low 30-day complication rate of 4.6%, indicating it is a safe option for patients with significant carotid artery disease.

The study found that CAS was successful in 99% of cases, with a notable 8.3% rate of in-hospital adverse events, primarily minor, suggesting that CAS can be an effective alternative to carotid endarterectomy for both symptomatic and asymptomatic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of carotid artery stenting in high-risk patients with carotid artery stenosis: a single neurovascular center retrospective review of 101 consecutive patients. Meyer, SA., Gandhi, CD., Johnson, DM., et al.[2010]

In a 9-year study involving 2,124 patients undergoing carotid artery stenting (CAS), the researchers developed the Siena CAS risk score to predict the 30-day risk of stroke based on various patient and procedural factors.

The Siena CAS score categorizes patients into low, medium, and high-risk groups for stroke, showing a sensitivity of 82% and specificity of 79%, but requires further validation before clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Siena carotid artery stenting score: a risk modelling study for individual patients. Setacci, C., Chisci, E., Setacci, F., et al.[2022]

In a study of 48 patients undergoing carotid angioplasty with stent implantation (CAS), the use of various cerebral protection devices significantly reduced procedural risks, with only one stroke occurring during the procedure.

Over a 6-month follow-up period, there were no deaths or strokes among 40 patients, indicating that CAS procedures are generally safe and have a low incidence of major cerebrovascular complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Carotid artery stenting with different cerebral protection systems]. Bartuś, S., Dudek, D., Rakowski, T., et al.[2010]

In a study of 19 patients with carotid artery stenosis or occlusion, successful carotid artery stenting (CAS) improved neurocognitive function, as evidenced by significant increases in Mini-Mental State Examination scores and verbal fluency tests after the procedure.

CAS also led to improvements in cerebral glucose metabolism, with 6 out of 9 patients showing enhanced metabolism on FDG PET scans, indicating that the procedure may help restore brain function in patients suffering from chronic cerebral hypoperfusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of Cerebral Glucose Metabolism in Symptomatic Patients With Carotid Artery Stenosis After Stenting. Kao, HL., Lin, MS., Wu, WC., et al.[2018]

Carotid artery angioplasty and stenting (CAS) is effective for treating carotid artery stenosis but carries a higher risk of periprocedural cerebrovascular events compared to carotid endarterectomy (CEA), highlighting the need for careful risk management.

Innovative embolic protection strategies and individualized device selection can significantly enhance the safety and efficacy of CAS, emphasizing the importance of thorough pre-procedural planning to minimize stroke risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procedural embolic protection strategies for carotid artery stenting: current status and future prospects. Miccichè, E., Condello, F., Cao, D., et al.[2023]

Citations

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of carotid artery stenting on cognitive function in patients with carotid artery stenosis: a prospective, 3-month-follow-up study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Ignoring floor and ceiling effects may underestimate the effect of carotid artery stenting on cognitive performance. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Neuropsychological sequelae of carotid angioplasty with stent placement: correlation with ischemic lesions in diffusion weighted imaging. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The impact of carotid artery stenting on cognitive function in patients with extracranial carotid artery stenosis. [2015]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Carotid Artery Stenting and Its Impact on Cognitive Function: A Prospective Observational Study. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Octogenarians are not at increased risk for periprocedural stroke following carotid artery stenting. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Carotid Angioplasty and Stenting and Embolic Protection. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Outcomes of carotid artery stenting in high-risk patients with carotid artery stenosis: a single neurovascular center retrospective review of 101 consecutive patients. [2010]

9. United States pubmed.ncbi.nlm.nih.gov

Siena carotid artery stenting score: a risk modelling study for individual patients. [2022]

10. Poland pubmed.ncbi.nlm.nih.gov

[Carotid artery stenting with different cerebral protection systems]. [2010]

11. United States pubmed.ncbi.nlm.nih.gov

Improvement of Cerebral Glucose Metabolism in Symptomatic Patients With Carotid Artery Stenosis After Stenting. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Procedural embolic protection strategies for carotid artery stenting: current status and future prospects. [2023]