Revascularization for Symptomatic Non-acute Carotid Artery Occlusion (RESCO)

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.

Study Overview

• Status: Recruiting
• Conditions: Non-acute Carotid Artery Occlusion
• Intervention / Treatment: Procedure: Carotid Endarterectomy (CEA); Procedure: Carotid Artery Stenting (CAS); Procedure: Hybrid Surgery

Detailed Description

Carotid artery occlusion is one of the primary causes of ischemic stroke. When the occlusion time exceeds 30 days, it is commonlly referred to as chronic carotid artery occlusion (CCAO), and patients with carotid artery occlusion over 24 hours are collectively referred as non-acute occlusion. Symptomatic non-acute occlusion patients with definite hemodynamic hypoperfusion still face a high risk of stroke recurrence under drug treatment, with recurrence rates reported to be between 12.3% and 22.7% within 2 years. Currently, the surgical methods for the treatment of carotid artery occlusion are mainly divided into extracranial-intracranial (EC-IC) bypass and recanalization treatment. Recanalization treatment includes CEA, endovascular intervention and hybrid surgery. While the Carotid Occlusion Surgery Study (COSS) and the recently published Carotid or Middle cerebral artery Occlusion Surgery Study (CMOSS) failed to reveal the significant advantages of EC-IC bypass surgery over medical treatment for patients with symptomatic artery occlusion combined with hemodynamic insufficiency, recanalization treatment has been shown to be a promising treatment modality by case-control studies with small sample size. However, 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. In addition, about half of non-acute occlusion patients have cognitive impairment, and the role of cerebral hemodynamics in cognitive impairment is still unclear. Therefore, 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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100053
    • Recruiting
    • Xuanwu Hospital, Capital Medical University.
    • Contact: Liqun Jiao, Dr.; Phone Number: 13911224991; Email: liqunjiao@sina.cn
  • Beijing
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Tao Wang, MD; Phone Number: 18810302298; Email: wangtao_dr@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

1. Older than 18 years old;
2. Sign the informed consent form;
3. Carotid occlusion at least 24h;
4. 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;
5. DSA confirmed common carotid artery or internal carotid artery (mTICI=0) occlusion;
6. Perfusion imaging confirms the presence of hypoperfusion in the corresponding area(CBF decrease);
7. The optimal medical treatment for patients who still have ischemic symptoms;
8. Routine DWI and ADC sequence examinations are performed before surgery no new infarction;

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Carotid Endarterectomy (CEA); Patients who are treated with CEA.	Procedure: Carotid Endarterectomy (CEA); 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 Artery Stenting (CAS); Patients who are treated with CAS.	Procedure: Carotid Artery Stenting (CAS); 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.
Hybrid Surgery; Patients who are treated with Hybrid Surgery.	Procedure: Hybrid Surgery; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	Defined as the target vessel residual stenosis less than 30% by CTA	Up to 24 hours after procedure
Procedural success rate	Defines as the residual stenosis of the target vessel is less than 30% by CTA, and free of peri-procedural complications(includes cranial nerve injury, cardiac arrest, anaphylaxis, failure to recanalize blood vessels, distal embolism events, massive blood loss during operation, and residual thrombosis in the stent after operation)	Up to 24 hours after procedure
Any stroke within 30 days, 90 days and 12 months after procedure	Any stroke within 30 days, 90 days and 12 months	Within 30 days, 90 days and 12 months post-procedure
Death within 30 days, 90 days and 12 months after procedure	Death within 30 days, 90 days and 12 months	Within30 days, 90 days and 12 months post-procedure
Cranial nerve injury	Number of participants who suffered from cranial nerve injury	Within 30 days and 90 days post-procedure
Carotid artery or internal carotid artery reocclusion	Number of participants who suffered from carotid artery or internal aryery rereocclusion (> 99%) detected by ultrasonography, CTA, MRA or DSA	Within 30 days, 90 days and 12 months post-procedure
Functional outcome	Functional outcome indicated by NIHSS (National Institutes of Health Stroke Scale: 0-42; 0 = no stroke 1-4 = minor stroke 5-15 = moderate stroke 15-20 moderate/severe stroke 21-42 = severe stroke ) or mRS (modified Rankin Scale: 0-6; 0-No symptoms at all. 1-No significant disability despite symptoms; able to carry out all usual duties and activities. 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. 3-Moderate disability; requiring some help, but able to walk without assistance. 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention. 6-Dead.)	Within 30 days and 90 days post-procedure
Other major complications	Other major complications, such as myocardial infarction, pulmonary infection, postoperative bleeding, peri-procedural embolism, arterial dissection, vascular perforation, in-stent thrombus, post-procedural hyperperfusion syndrome, procedure related low perfusion infarction, etc.	Within 30 days, 90 days and 12 months post-procedure

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2016
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: RESCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Please contact the PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No