Carotid Revascularization for Radiation Induced Carotid Artery Stenosis (CRICS)

Outcomes of Carotid Revascularization for Patients With Radiation Induced Carotid Artery Stenosis in China

Cervical radiotherapy (RT) has greatly reduced the mortality of patients with malignant head and neck tumors, which, however, causes a higher risk of carotid artery stenosis, namely, radiation-induced carotid artery stenosis (RICS) and results in a significant increased risk of ischemic stroke. The systematic review and meta-analysis conducted by our team showed carotid endarterectomy (CEA) can yield better results for these patients than carotid artery stenting (CAS), which was contrary to most previous clinical guidelines. A large-scale prospective study is needed to verify the results. We will conduct a prospective registry of RICS patients treated with CEA to evaluate both short-term safety and long-term efficacy outcomes in a Chinese population.

Study Overview

• Status: Recruiting
• Conditions: Radiation-induced Carotid Artery Stenosis
• Intervention / Treatment: Procedure: Carotid endarterectomy (CEA); Procedure: Carotid artery stenting (CAS)

• Study Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

• Study Contact: Name: Tao Wang, MD; Phone Number: 18810302298; Email: wangtao_dr@sina.com
• Study Contact Backup: Name: Liqun Jiao, MD; Phone Number: 13911224991; Email: liqunjiao@sina.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Tao Wang, MD; Phone Number: 18810302298; Email: wangtao_dr@sina.com
      • Sub-Investigator: Xiao Zhang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with RICS and fulfilled the above eligible criteria in tertiary medical centers in China, will be enrolled consecutively.

Description

Inclusion Criteria:

• Patients with carotid stenosis who had a history of radiotherapy for head and neck cancer. (The median interval between the completion of radiation therapy and development of carotid artery stenosis detected on imaging (or vascular intervention) was no less than 1 years to avoid non-related situations. The target area of the radiotherapy included at least the ipsilateral neck, including part of the carotid system. The internal carotid stenosis was confirmed by angiography, Duplex, 3D angio-CTA or angio-MRI, and stenosis was defined as > 50% based on North American Symptomatic Carotid Endarterectomy Trial criteria), with or without symptom. Patients with a transient ischaemic attack (TIA) or stroke within 6 months were defined as symptomatic. TIA was defined as a transient episode of neurological dysfunction (focal weakness/ language disturbance/transient monocular blindness/ requiring assistance to walk) caused by focal brain or retinal ischemia that lasts for at least 10 min but resolves within 24 h.)

Exclusion Criteria:

• The patients treated for restenosis.
• Intracranial arteriovenous malformation or aneurysm
• Severe stenosis or occlusion of the ipsilateral intracranial artery
• Unstable angina, myocardial infarction (MI), or congestive heart failure in the last 6 months
• Uncorrectable coagulation abnormalities
• Uncontrolled diabetes mellitus defined as glucose > 300 mg/dL (16.67 mmol/L)
• Pregnant or in the perinatal period
• Severe concomitant disease with poor prognosis (life expectancy < 2 years)
• Intolerance or allergies to any of the study medications, such as aspirin or clopidogrel

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Carotid endarterectomy (CEA); Patients who are treated with 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 and CAS. 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); 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 and CAS. 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, local anaesthesia and predilation prior to stent placement are recommended. Use of an embolic protection device is mandatory for all patients who undergo CAS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke or death within 1 month	A composite of any stroke or death occurring within 1-month post-procedure.	Within 1-month post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke within 1 month	Stroke within 1 month	Within 1-month post-procedure
Death within 1 month	Death within 1 month	Within 1-month post-procedure
Cranial nerve injury	Number of participants who suffered from cranial nerve injury	Within 1-month post-procedure
Carotid artery restenosis	Number of participants who suffered from carotid artery restenosis (> 50%) detected by ultrasonography, CTA, or DSA	Within 1-year post-procedure
Functional outcome	Functional outcome indicated by NIHSS (National Institutes of Health Stroke Scale: 0-42; higher scores indicate worse outcome) or mRS (modified Rankin Scale: 0-6; higher scores indicate worse outcome)	Within 1-month and 1-year post-procedure
Other major complications	Other major complications, such as myocardial infarction, incision hematoma, pulmonary infection, etc.	Within 1-month post-procedure

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Study Chair: Liqun Jiao, MD, Xuanwu Hospital, Beijing; Principal Investigator: Tao Wang, MD, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 5, 2020
• Primary Completion (ANTICIPATED): December 31, 2026
• Study Completion (ANTICIPATED): December 31, 2027

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (ACTUAL): November 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 25, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Outcomes; Carotid endarterectomy; Radiation-induced carotid artery stenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Carotid Stenosis; Constriction, Pathologic
• Other Study ID Numbers: CRICS

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