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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.)

Locations
Other Locations
China
Xuanwu Hospital, Capital Medical University
RECRUITING
Beijing
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Contact Information
Primary
Tao Wang, MD
wangtao_dr@sina.com
18810302298
Backup
Liqun Jiao, MD
liqunjiao@sina.cn
13911224991
Time Frame
Start Date: 2020-01-05
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 150
Treatments
Carotid endarterectomy (CEA)
Patients who are treated with CEA.
Carotid artery stenting (CAS)
Patients who are treated with CAS.
Related Therapeutic Areas
Sponsors
Collaborators: Guangdong Provincial People's Hospital
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov