Efficacy and Prognosis of Surgical Intervention in Patients With Carotid Artery Stenosis

NCT06222983 | Unknown DMC

• 1 other identifier: EPSIPCS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 CEA) for high-risk plaque patients with carotid stenosis.

Conditions

Carotid Artery Stenting; Carotid Endarterectomy; Carotid Artery Plaque

Keywords

Carotid Revascularization; Carotid Artery Stenting; Carotid Endarterectomy

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  30days

• Incidence of ipsilateral stroke

  Incidence of ipsilateral stroke at 30 days follow up

  30days

• Incidence of death

  Incidence of death at 30 days follow up.

  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.

  3,6,12 months

• Improvement in cognitive function

  Cognitive function was assessed by Mini-mental State Examination (MMSE) during follow up.

  0,3,6,12months

• Improvement in cognitive function

  Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) during follow up.

  0,3,6,12months

• Quality of life rating

  Use VascuQol to evaluate quality of life scores

  30 days

Secondary Outcomes (3)

• Ultrasound and pathological indicators related to high-risk plaques

  0-7days

• CT and pathological indicators related to high-risk plaques

  0-7days

• MRI and pathological indicators related to high-risk plaques

  0-7days

Study Arms (2)

CEA group

CEA for atherosclerosis

Procedure: CEA or CAS

CAS group

CEA for atherosclerosis

Procedure: CEA or CAS

Interventions

CEA or CAS PROCEDURE

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

CAS group; CEA group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Lianrui Guo

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lianrui Guo, Dr.

CONTACT

+8613671009746; lianguiguo@sina.com

Xixiang Gao, Dr.

CONTACT

: +8613581674309; vascsurgeon@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 25, 2024
• Study Start: December 31, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

CN (1)