Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Guangdong Provincial People's Hospital | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carotid endarterectomy (CEA) | Patients who are treated with CEA. |
| |
| Carotid artery stenting (CAS) | Patients who are treated with CAS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke beyond 1 month within 1 year | Stroke beyond 1 month within 1 year | Beyond 1-month and within 1 year post-procedure |
| Death beyond 1 month within 1 year | Death beyond 1 month within 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients diagnosed with RICS and fulfilled the above eligible criteria in tertiary medical centers in China, will be enrolled consecutively.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Wang, MD | Contact | 18810302298 | wangtao_dr@sina.com | |
| Liqun Jiao, MD | Contact | 13911224991 | liqunjiao@sina.cn |
| Name | Affiliation | Role |
|---|---|---|
| Liqun Jiao, MD | Xuanwu Hospital, Beijing | Study Chair |
| Tao Wang, MD | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100005 | China |
Please contact the PI.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016894 | Endarterectomy, Carotid |
| ID | Term |
|---|---|
| D004691 | Endarterectomy |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
We will collect the carotid plaque for patients treated with carotid endarterectomy.
|
| 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. |
|
| Beyond 1-month and within 1 year post-procedure |
| Stroke or death within 1 year | Stroke or death within 1 year | Within 1 year 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-year post-procedure |
| Other major complications | Other major complications, such as myocardial infarction, incision hematoma, pulmonary infection, etc. | Within 1-month post-procedure |
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
|