Radiation-induced Carotid Artery StenosisCRICSNCT05134246
Carotid Revascularization for Radiation Induced Carotid Artery Stenosis
An observational study of Radiation-induced Carotid Artery Stenosis, run by Xuanwu Hospital, Beijing at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation-induced Carotid Artery Stenosis
- What is being tested?
- Carotid endarterectomy (CEA) and Carotid artery stenting (CAS)
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 5 Jan 2020to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with RICS and fulfilled the above eligible criteria in tertiary medical centers in China, will be enrolled consecutively.
Who may be able to join
- 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.)
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100005
Tao Wang, MD, 18810302298, wangtao_dr@sina.com
Xiao Zhang, MD
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Guangzhong Chen, MD, 86+15510296383, chenguangzhong@gdph.org.cn
About this study
Official title: 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.
- Being tested
- Carotid endarterectomy (CEA), Carotid artery stenting (CAS)
- Keywords
- Radiation-induced carotid artery stenosis, Carotid endarterectomy, Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid endarterectomy (CEA)Procedure or 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 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)Procedure or 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Carotid endarterectomy (CEA) | Patients who are treated with CEA. Receives: Procedure: Carotid endarterectomy (CEA) | |
| Carotid artery stenting (CAS) | Patients who are treated with CAS. Receives: Procedure: Carotid artery stenting (CAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke or death within 1 month
A composite of any stroke or death occurring within 1-month post-procedure.
Measured: Within 1-month post-procedure
Secondary outcomes (7)
Stroke beyond 1 month within 1 year
Stroke beyond 1 month within 1 year
Measured: Beyond 1-month and within 1 year post-procedure
Death beyond 1 month within 1 year
Death beyond 1 month within 1 year
Measured: Beyond 1-month and within 1 year post-procedure
Stroke or death within 1 year
Stroke or death within 1 year
Measured: Within 1 year post-procedure
Cranial nerve injury
Number of participants who suffered from cranial nerve injury
Measured: Within 1-month post-procedure
Carotid artery restenosis
Number of participants who suffered from carotid artery restenosis (> 50%) detected by ultrasonography, CTA, or DSA
Measured: 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)
Measured: Within 1-year post-procedure
Other major complications
Other major complications, such as myocardial infarction, incision hematoma, pulmonary infection, etc.
Measured: Within 1-month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start5 Jan 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Liqun Jiao, MD, Study chair, Xuanwu Hospital, BeijingTao Wang, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134246
- Sponsor's protocol ID
- CRICS
- Acronym
- CRICS
- Status last verified
- Feb 2025
- First submitted
- 11 Nov 2021
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Please contact the PI.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Carotid Revascularization for Patients With Radiation Induced Carotid Artery Stenosis in China
- ClinicalTrials.gov ID
- NCT05134246
- Acronym / sponsor ID
- CRICS / CRICS
- Keywords
- Radiation-induced carotid artery stenosis, Carotid endarterectomy, Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotid endarterectomy (CEA) | – | Procedure: Carotid endarterectomy (CEA)Patients who are treated with CEA. |
| Carotid artery stenting (CAS) | – | Procedure: Carotid artery stenting (CAS)Patients who are treated with CAS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with RICS and fulfilled the above eligible criteria in tertiary medical centers in China, will be enrolled consecutively.
Key inclusion criteria (1 listed)
- 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.)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Carotid endarterectomy (CEA) |
| 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. | Procedure or surgery | Carotid artery stenting (CAS) |
Primary outcome
Stroke or death within 1 month
Time frame: Within 1-month post-procedure
A composite of any stroke or death occurring within 1-month post-procedure.
7 secondary outcomes
Stroke beyond 1 month within 1 year
Time frame: Beyond 1-month and within 1 year post-procedure
Death beyond 1 month within 1 year
Time frame: Beyond 1-month and within 1 year post-procedure
Stroke or death within 1 year
Time frame: Within 1 year post-procedure
Cranial nerve injury
Time frame: Within 1-month post-procedure
Carotid artery restenosis
Time frame: Within 1-year post-procedure
Functional outcome
Time frame: Within 1-year post-procedure
Other major complications
Time frame: Within 1-month post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: Undecided. Please contact the PI.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liqun Jiao, MD study chair
Xuanwu Hospital, Beijing
Tao Wang, MD principal investigator
Xuanwu Hospital, Beijing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation-induced Carotid Artery Stenosis, run by Xuanwu Hospital, Beijing at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Wang, MD (18810302298, wangtao_dr@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke or death within 1 month (time frame: Within 1-month post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.