Carotid Artery StentingNCT06222983
Efficacy and Prognosis of Surgical Intervention in Patients With Carotid Artery Stenosis
An observational study of Carotid Artery Stenting and Carotid Endarterectomy, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study is a prospective, single center cohort study. By combining pathological examination of carotid atherosclerotic plaque with preoperative imaging examination, we explore the imaging characteristics of high-risk carotid plaque, and explore the effectiveness and safety of different surgical methods (CAS and… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Carotid Artery Stenting, Carotid Endarterectomy, Carotid Artery Plaque
- What is being tested?
- CEA or CAS
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2023to 1 Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patients with spontaneous intracranial hemorrhage within the past 12 months; 2. Patients with larger intracranial aneurysms (diameter>5mm) that cannot be treated in advance or at the same time; 3. Patients with chronic complete occlusion without obvious symptoms of cerebral ischemia; 4. Patients with severe dementia; 5. Carotid artery opening lesion; 6. Severe intracranial serial stenosis lesions; 7. Carotid artery dissection; 8. Lesions with combined carotid artery aneurysm; 9. Patients with generally poor physical condition who cannot tolerate surgery; 10. Coagulation dysfunction, contraindications to heparin and antiplatelet drugs; 11. Patients who are participating in clinical trials of other drugs or devices but have not reached the trial endpoint; 12. Pregnant and lactating women; 13. The researchers believe that patients who are not suitable to participate in this trial.
Who may be able to join
- The patient is aged 45-85 years old;
- Symptomatic patients with stenosis degree greater than 50%, or asymptomatic patients with stenosis degree between 70% and 99% (ultrasound, CT or contrast);
- Can complete regular follow-up;
- The patient is informed and agrees to participate in the study.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing
Lianrui Guo, Dr.
Xixiang Gao, Dr., +8613581674309, vascsurgeon@163.com
About this study
Official title: A Prospective Cohort Study on the Efficacy and Prognosis of Surgical Intervention in Patients With Carotid Artery Stenosis
This study is a prospective, single center cohort study. By combining pathological examination of carotid atherosclerotic plaque with preoperative imaging examination, we explore the imaging characteristics of high-risk carotid plaque, and explore the effectiveness and safety of different surgical methods (CAS and CEA) for high-risk plaque patients with carotid stenosis.
Read the detailed description
According to the inclusion and exclusion criteria, 100 patients with carotid artery stenosis who underwent surgical reconstruction surgery at our research center were prospectively collected from December 2023 to December 2024. Preoperative laboratory examinations such as blood routine, biochemistry, coagulation, and imaging examinations such as carotid artery ultrasound and TCCD, carotid artery ultrasound contrast, high-resolution MRI, head MRI plain scan, carotid artery CTA or DSA were completed, Based on the comprehensive evaluation of the patient's condition by the supervising physician, the appropriate surgical method (CEA or CAS) is selected. Follow up will be conducted 1/3/6/12 months after surgery to evaluate the incidence of endpoint events (cerebral infarction+all-cause death+postoperative restenosis), MoCA and MMSE cognitive scores, quality of life scores, and severe perioperative complications. At the same time, for patients undergoing CEA surgery, pathological examination of the postoperative carotid artery plaque will be conducted to clarify the nature of the plaque, and combined with imaging examination, the characteristics of high-risk carotid artery plaques will be studied
- Being tested
- CEA or CAS
- Keywords
- Carotid Revascularization, Carotid Artery Stenting, Carotid Endarterectomy
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEA or CASProcedure or surgery
After the patient is admitted to the hospital, the supervising doctor comprehensively evaluates the patient's general condition and adopts CEA or CAS treatment. The researcher does not provide advice to the supervising doctor and only observes safety and effectiveness
| Study group | Role | What they receive |
|---|---|---|
| CEA group | CEA for atherosclerosis Receives: Procedure: CEA or CAS | |
| CAS group | CEA for atherosclerosis Receives: Procedure: CEA or CAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 to 12-months.
Composite of any periprocedural stroke (ipsilateral or contralateral; major or minor), myocardial infarction, or death during1 month peri-procedural period, and postprocedural ipsilateral stroke 1 to 12-months.
Measured: 0 to 12 months
Rate of complications
Rate of complications within 30 days, complications include cranial nerve and peripheral nerve injury, vascular injury, wound complications as neck incision or related to puncture site, and other (such as anesthesia) complications.
Measured: 30days
Incidence of ipsilateral stroke
Incidence of ipsilateral stroke at 30 days follow up
Measured: 30days
Incidence of death
Incidence of death at 30 days follow up.
Measured: 30 days
Carotid restenosis rate
Carotid restenosis was defined as restenosis ≥50% after carotid revascularization, that is, peak systolic velocity ratio (PSVR) ≥2.0 on ultrasound examination.
Measured: 3,6,12 months
Improvement in cognitive function
Cognitive function was assessed by Mini-mental State Examination (MMSE) during follow up.
Measured: 0,3,6,12months
Improvement in cognitive function
Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) during follow up.
Measured: 0,3,6,12months
Quality of life rating
Use VascuQol to evaluate quality of life scores
Measured: 30 days
Secondary outcomes (3)
Ultrasound and pathological indicators related to high-risk plaques
Ultrasound are used to visualize plaques, combined with pathological examination, to identify the imaging characteristics of high-risk plaques
Measured: 0-7days
CT and pathological indicators related to high-risk plaques
CT are used to visualize plaques, combined with pathological examination, to identify the imaging characteristics of high-risk plaques
Measured: 0-7days
MRI and pathological indicators related to high-risk plaques
MRI are used to visualize plaques, combined with pathological examination, to identify the imaging characteristics of high-risk plaques
Measured: 0-7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start31 Dec 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StentingStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lianrui Guo, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222983
- Sponsor's protocol ID
- EPSIPCS
- Status last verified
- Jan 2024
- First submitted
- 7 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on the Efficacy and Prognosis of Surgical Intervention in Patients With Carotid Artery Stenosis
- ClinicalTrials.gov ID
- NCT06222983
- Acronym / sponsor ID
- EPSIPCS
- Keywords
- Carotid Revascularization, Carotid Artery Stenting, Carotid Endarterectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 31 Dec 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 25 Jan 2024 (actual)
- 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 is a prospective, single center cohort study. By combining pathological examination of carotid atherosclerotic plaque with preoperative imaging examination, we explore the imaging characteristics of high-risk carotid plaque, and explore the effectiveness and safety of different surgical methods (CAS and CEA) for high-risk plaque patients with carotid stenosis.
Detailed description
According to the inclusion and exclusion criteria, 100 patients with carotid artery stenosis who underwent surgical reconstruction surgery at our research center were prospectively collected from December 2023 to December 2024. Preoperative laboratory examinations such as blood routine, biochemistry, coagulation, and imaging examinations such as carotid artery ultrasound and TCCD, carotid artery ultrasound contrast, high-resolution MRI, head MRI plain scan, carotid artery CTA or DSA were completed, Based on the comprehensive evaluation of the patient's condition by the supervising physician, the appropriate surgical method (CEA or CAS) is selected. Follow up will be conducted 1/3/6/12 months after surgery to evaluate the incidence of endpoint events (cerebral infarction+all-cause death+postoperative restenosis), MoCA and MMSE cognitive scores, quality of life scores, and severe perioperative complications. At the same time, for patients undergoing CEA surgery, pathological examination of the postoperative carotid artery plaque will be conducted to clarify the nature of the plaque, and combined with imaging examination, the characteristics of high-risk carotid artery plaques will be studied
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEA group | – | Procedure: CEA or CASCEA for atherosclerosis |
| CAS group | – | Procedure: CEA or CASCEA for atherosclerosis |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with spontaneous intracranial hemorrhage within the past 12 months; 2. Patients with larger intracranial aneurysms (diameter>5mm) that cannot be treated in advance or at the same time; 3. Patients with chronic complete occlusion without obvious symptoms of cerebral ischemia; 4. Patients with severe dementia; 5. Carotid artery opening lesion; 6. Severe intracranial serial stenosis lesions; 7. Carotid artery dissection; 8. Lesions with combined carotid artery aneurysm; 9. Patients with generally poor physical condition who cannot tolerate surgery; 10. Coagulation dysfunction, contraindications to heparin and antiplatelet drugs; 11. Patients who are participating in clinical trials of other drugs or devices but have not reached the trial endpoint; 12. Pregnant and lactating women; 13. The researchers believe that patients who are not suitable to participate in this trial.
Key inclusion criteria (4 listed)
- The patient is aged 45-85 years old;
- Symptomatic patients with stenosis degree greater than 50%, or asymptomatic patients with stenosis degree between 70% and 99% (ultrasound, CT or contrast);
- Can complete regular follow-up;
- The patient is informed and agrees to participate in the study.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| CEA or CASAfter the patient is admitted to the hospital, the supervising doctor comprehensively evaluates the patient's general condition and adopts CEA or CAS treatment. The researcher does not provide advice to the supervising doctor and only observes safety and effectiveness | Procedure or surgery | CAS group, CEA group |
Primary outcome
Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 to 12-months.
Time frame: 0 to 12 months
Composite of any periprocedural stroke (ipsilateral or contralateral; major or minor), myocardial infarction, or death during1 month peri-procedural period, and postprocedural ipsilateral stroke 1 to 12-months.
Rate of complications
Time frame: 30days
Rate of complications within 30 days, complications include cranial nerve and peripheral nerve injury, vascular injury, wound complications as neck incision or related to puncture site, and other (such as anesthesia) complications.
Incidence of ipsilateral stroke
Time frame: 30days
Incidence of ipsilateral stroke at 30 days follow up
Incidence of death
Time frame: 30 days
Incidence of death at 30 days follow up.
Carotid restenosis rate
Time frame: 3,6,12 months
Carotid restenosis was defined as restenosis ≥50% after carotid revascularization, that is, peak systolic velocity ratio (PSVR) ≥2.0 on ultrasound examination.
Improvement in cognitive function
Time frame: 0,3,6,12months
Cognitive function was assessed by Mini-mental State Examination (MMSE) during follow up.
Improvement in cognitive function
Time frame: 0,3,6,12months
Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) during follow up.
Quality of life rating
Time frame: 30 days
Use VascuQol to evaluate quality of life scores
3 secondary outcomes
Ultrasound and pathological indicators related to high-risk plaques
Time frame: 0-7days
CT and pathological indicators related to high-risk plaques
Time frame: 0-7days
MRI and pathological indicators related to high-risk plaques
Time frame: 0-7days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Safety and Efficacy of a Novel Composite-Tip Guiding Catheter in Transcarotid Artery Stenting Via Transradial Access
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Safety and Efficacy of Carotid Artery Stenting Combined With Intermittent Hypoxia Intervention in Patients With Severe Internal Carotid Artery Stenosis
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CEST-PROTECT: Proximal Flow Control With a Balloon Guide Catheter Plus Distal Embolic Protection: a Randomised, Open-label Trial Evaluating Cerebral Protection Techniques
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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.
Lianrui Guo principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenting and Carotid Endarterectomy, run by Xuanwu Hospital, Beijing at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 25 Jan 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lianrui Guo, Dr. (+8613671009746, lianguiguo@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 to 12-months. (time frame: 0 to 12 months). The study lists 8 primary outcomes in all. 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 25 Jan 2024.