Revascularization for Symptomatic Non-acute Carotid Artery Occlusion

NCT06303414 | Recruiting DMC

• 1 other identifier: RESCO
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

The short-term and long-term efficacy of recanalization therapy needs to be further confirmed by large-sample prospective studies. The comparison of success rate, complication rate and efficacy among the three recanalization modalities also needs to be further explored. The purpose of this cohort study is to observe the success rate, efficacy and safety of recanalization treatment for non-acute occlusion, and to further compare the advantages and disadvantages of CEA, endovascular intervention and hybrid surgery.

Conditions

Non-acute Carotid Artery Occlusion

Outcome Measures

Primary Outcomes (3)

• Stroke or death whthin 30 days or recurrent ischemic stroke related of qualifying artery beyond 30 days through 12 months

  Including TIA, minor stroke, moderate stroke, severe stroke, and fatal stroke

  Up to 12 months after procedure

• MMSE within 30 and 90 days after procedure

  The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment. The MMSE's purpose has been not, on its own, to provide a diagnosis for any particular nosological entity.

  30 days and 90 days after procedure

• MoCA scale within 30 and 90 days after procedure

  The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment.The MoCA test is a one-page 30-point test administered in approximately 10 minutes. The MoCA assesses: Short term memory/ Visuospatial abilities/ Executive functions/ Attention, concentration and working memory/ Language/ Orientation to time and place.

  30 days and 90 days after procedure

Secondary Outcomes (8)

• Technical success rate

  Up to 24 hours after procedure

• Procedural success rate

  Up to 24 hours after procedure

• Any stroke within 30 days, 90 days and 12 months after procedure

  Within 30 days, 90 days and 12 months post-procedure

• Death within 30 days, 90 days and 12 months after procedure

  Within30 days, 90 days and 12 months post-procedure

• Cranial nerve injury

  Within 30 days and 90 days post-procedure

Study Arms (3)

Carotid Endarterectomy (CEA)

Patients who are treated with CEA.

Procedure: Carotid Endarterectomy (CEA)

Carotid Artery Stenting (CAS)

Patients who are treated with CAS.

Procedure: Carotid Artery Stenting (CAS)

Hybrid Surgery

Patients who are treated with Hybrid Surgery.

Procedure: Hybrid Surgery

Interventions

Carotid Endarterectomy (CEA) PROCEDURE

Carotid endarterectomy (CEA) Surgeons follow the contemporary guideline combined with their experience and preference in order to ultimately select what is best suited for the patient and choose between CEA, CAS and Hybrid Sugery. Patients will receive 100 mg of aspirin or 75 mg of clopidogrel daily starting from at least 72 h prior to the CEA procedure and continued receiving the medication indefinitely. General anesthesia is recommended for CEA, although the use of standard or eversion endarterectomy, and a shunt or patch, is left to the discretion of the surgeon.

Carotid Endarterectomy (CEA)

Carotid Artery Stenting (CAS) PROCEDURE

Carotid artery stenting (CAS) Surgeons follow the contemporary guideline combined with their experience and preference in order to ultimately select what is best suited for the patient and choose between CEA, CAS and Hybrid Sugery. Patients will be given 100 mg of aspirin plus 75 mg of clopidogrel daily for at least 3 days before the CAS procedure and for 90 days after the procedure. They will receive a daily dose of 100 mg aspirin or 75 mg clopidogrel thereafter. For the CAS procedure, general anesthesia and predilation prior to stent placement are recommended. Use of an embolic protection device is advised for all patients who undergo CAS.

Carotid Artery Stenting (CAS)

Hybrid Surgery PROCEDURE

Hybrid Surgery Surgeons follow the contemporary guideline combined with their experience and preference in order to ultimately select what is best suited for the patient and choose between CEA, CAS and Hybrid Sugery. Patients will be given 100 mg of aspirin plus 75 mg of clopidogrel daily for at least 5 days before the hybird surgery procedure. If they had stenting procedure, they will receive a daily dose of 100 mg aspirin and 75 mg clopidogrel thereafter. If not, they will take either 100mg aspirin or 75mg clopidogrel daily for life.

Hybrid Surgery

Eligibility Criteria

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

Study Population

People diagnosed with non-acute carotid occlusion, fulfilled the above eligible criteria in tertiary medical centers in China additionally will be enrolled consecutively.

You may qualify if:

• Older than 18 years old;
• Sign the informed consent form;
• Carotid occlusion at least 24h;
• Patients with clinical localization symptoms: ipsilateral hemisphere ischemia symptoms or ipsilateral eye ischemia symptoms or cognition impairment, with or without anterior circulation blood supply area infarction;
• DSA confirmed common carotid artery or internal carotid artery (mTICI=0) occlusion;
• Perfusion imaging confirms the presence of hypoperfusion in the corresponding area(CBF decrease);
• The optimal medical treatment for patients who still have ischemic symptoms;
• Routine DWI and ADC sequence examinations are performed before surgery no new infarction;

You may not qualify if:

• Intracranial arteriovenous malformation or aneurysm;
• Unstable angina, myocardial infarction (MI), or congestive heart failure in the last 6 months;
• Uncontrolled diabetes mellitus defined as glucose \> 300 mg/dL (16.67 mmol/L);
• Patient is expected to have the ADP antagonist therapy interruption within 3 months after the procedure;
• Pregnant or in the perinatal period;
• Severe concomitant disease with poor prognosis (life expectancy \< 3 years);
• Intolerance or allergies to any of the study medications, such as aspirin or clopidogrel;
• Allergy to iodine or radiographic contrast media;
• Concomitant vascular conditions precluding endovascular;
• Patients with large cerebral infarction within 2 weeks;
• History of ipsilateral vocal cord paralysis;
• Those with severe skin diseases who are expected to have difficulty healing the incision;
• Poor functional status before onset (mRS score 4-5 points).
• The area of infarction in the occluded vascular area exceeds half of the vascular supply area;
• Already have dementia or psychiatric illness and are unable to complete neurological and cognitive assessments.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (2)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100005, China

RECRUITING

Xuanwu Hospital, Capital Medical University.

Beijing, 100053, China

RECRUITING

MeSH Terms

Interventions

Endarterectomy, Carotid

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

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: March 4, 2024
• First Posted: March 12, 2024
• Study Start: June 17, 2016
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 12, 2024

Record last verified: 2016-06

Locations

CN (2)