An observational study in Carotid Stenosis, Surgery and Stroke, sponsored by Xuanwu Hospital, Beijing. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2013-11-25.
Sponsored by Xuanwu Hospital, Beijing · Observational
Investigate the current situation of carotid stenosis therapy in China. Establish the data bank of carotid stenosis revascularization (CAS and CEA) in China ,in order to get best quality control of the therapy, as well as confirm the standard treatment for carotid stenosis.
Understand situation about the adverse events occurs after the revascularization (CAS and CEA), evaluate the health economics .
The carotid stenosis was one of the higher risk of the ischemia stroke in China.In the mean time ,more and more people accept revascularization because of carotid stenosis.NASCAT indicated that CEA is the "golden standard" of the therapy of the carotid stenosis.But in china , case the opposite,only little patient receive CEA,on the other hand , most patients received angioplasty.
Expected no less than 2100 cases within 2 years for the whole study. We choose 39 hospitals whose experienced in CAS or/and CEA spread all over the country as multiple centers for this clinic registration study. All cases inclusion must be continuously registration.
The subject choice:All registered patients must be signed informed consent to register for non intrusive research this study ,the researchers during the study period should be continuous registration in patients undergoing surgical treatment of carotid stenosis, to ensure that the selected participants reflect the target patient population.
Medical Center choice: This research for the study of the registration, therefore, when the choice, all the medical center will be based on market research data.
Primary endpoint or the main aim of this registration study is to observe the following details:
Secondary endpoint or the other aims of this registration study:
This study does not need to be random. The study is expected to begin in July 2013 in the first, participants in the group stage for two years, to the end of June 2015 into the group of patients after surgery, follow-up of at least 12 months after the last case the participants into groups and followed up for 12 months, is expected to be completed in June 2015.
339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.
This study's planned enrollment of 2,100 is above the median of 173 across 144 observational studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.
Counted across the registry records on this site, refreshed daily.
one group:1050 cases of endarterectomy; the other group:1050 cases of carotid artery stent; totally:2100 cases of ravascularization for carotid stenosis
Inclusion Criteria:all the consecutive cases of carotid stenosis which received CEA or/and CAS in central hospital during the study(upto 2015).
Exclusion Criteria:the cases of carotid stenosis which received CEA or/and CAS in other hospital(not enroll this study) will be exclusion.
CAS:the patient who accepted carotid angioplasty due to catotid artery stenosis CEA:the patient who accepted carotid endarterectomy due to catotid artery stenosis
Procedure: Carotid endarterectomy · Procedure: carotid angioplasty
Also known as: conventional carotid endarterectomy, Eversion carotid endarterectomy
Also known as: carotid angioplasty with stent
The participants who suffer from stroke(ischemic or hemorrhagic), death or cardiovascular events within 30 days after any revascularization procedure.
The participants who suffer from stroke(ischemic or hemorrhagic), death or cardiovascular events within 30 days after any revascularization procedure.
Time frame: 30 days
The participants who suffer from ipsilateral stroke(ischemic or hemorrhagic) or death beyond 30 days to 12 months after any revascularization procedure.
The participants who suffer from ipsilateral stroke(ischemic or hemorrhagic) or death beyond 30 days to 12 months after any revascularization procedure.
Time frame: beyond 30 days to 12 months
Success rate of any procedure (CAS or CEA)
Success rate of any procedure (CAS or CEA)
Time frame: 1 days
postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.
postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.
Time frame: 7 days
To observe the rate of restenosis during follow-up.
To observe the rate of restenosis during follow-up.
Time frame: 12 months
Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up.
Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up.
Time frame: 12 months
Changes of the patients with mRS NIHSS Barthel Index score
Changes of the patients with mRS NIHSS Barthel Index score
Time frame: 12 months
Postoperative patients with drug use
Postoperative patients with drug use
Time frame: 12 months
Patient survival after 12 months
Patient survival after 12 months
Time frame: 12 months
Patients hospitalized cost
Patients hospitalized cost
Time frame: 5-7 days
This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Xuanwu Hospital, Beijing