Carotid Revascularization for Radiation Induced Carotid Artery Stenosis

NCT05134246 | Recruiting DMC

• 1 other identifier: CRICS
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Radiation-induced Carotid Artery Stenosis

Keywords

Radiation-induced carotid artery stenosis; Carotid endarterectomy; Outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Stroke beyond 1 month within 1 year

  Beyond 1-month and within 1 year post-procedure

• Death beyond 1 month within 1 year

  Beyond 1-month and within 1 year post-procedure

• Stroke or death within 1 year

  Within 1 year post-procedure

• Cranial nerve injury

  Within 1-month post-procedure

• Carotid artery restenosis

  Within 1-year post-procedure

Study Arms (2)

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)

Interventions

Carotid endarterectomy (CEA) PROCEDURE

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 endarterectomy (CEA)

Carotid artery stenting (CAS) PROCEDURE

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.

Carotid artery stenting (CAS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Guangdong Provincial People's Hospital: collaborator

Study Sites (2)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100005, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We will collect the carotid plaque for patients treated with carotid endarterectomy.

MeSH Terms

Interventions

Endarterectomy, Carotid

Intervention Hierarchy (Ancestors)

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

Study Officials

• Liqun Jiao, MD

  Xuanwu Hospital, Beijing

  STUDY CHAIR

• Tao Wang, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Wang, MD

CONTACT

18810302298; wangtao_dr@sina.com

Liqun Jiao, MD

CONTACT

13911224991; liqunjiao@sina.cn

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: November 11, 2021
• First Posted: November 24, 2021
• Study Start: January 5, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

CN (2)