Revascularization of Extracranial Carotid Artery Stenosis (RECAS)
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ClinicalTrials.gov Identifier: NCT01994187 |
Recruitment Status : Unknown
Verified September 2013 by Xuanwu Hospital, Beijing.
Recruitment status was: Recruiting
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
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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 .
Condition or disease | Intervention/treatment |
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Carotid Stenosis Surgery Stroke | Procedure: Carotid endarterectomy Procedure: carotid angioplasty |
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:
- 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 ipsilateral stroke(ischemic or hemorrhagic) or death beyond 30 days to 12 months after any revascularization procedure.
Secondary endpoint or the other aims of this registration study:
- Success rate of any procedure (CAS or CEA).
- postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.
- To observe the rate of restenosis during follow-up.
- Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up.
- Changes of the patients with mRS NIHSS Barthel Index score.
- Postoperative patients with drug use.
- Patient survival after 12 months.
- Patients hospitalized cost during follow-up.
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.
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 2100 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 12 Months |
Official Title: | the Clinic Registration Study of Carotid Stenosis Revascularization |
Study Start Date : | July 2013 |
Estimated Primary Completion Date : | June 2015 |
Estimated Study Completion Date : | June 2015 |
Group/Cohort | Intervention/treatment |
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CAS or CEA
CAS:the patient who accepted carotid angioplasty due to catotid artery stenosis CEA:the patient who accepted carotid endarterectomy due to catotid artery stenosis
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Procedure: Carotid endarterectomy
Other Names:
Procedure: carotid angioplasty Other Name: carotid angioplasty with stent |
- 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 stroke(ischemic or hemorrhagic), death or cardiovascular events within 30 days 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 ]The participants who suffer from ipsilateral stroke(ischemic or hemorrhagic) or death beyond 30 days to 12 months after any revascularization procedure.
- Success rate of any procedure (CAS or CEA) [ Time Frame: 1 days ]Success rate of any procedure (CAS or CEA)
- postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events. [ Time Frame: 7 days ]postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.
- To observe the rate of restenosis during follow-up. [ Time Frame: 12 months ]To observe the rate of restenosis during follow-up.
- Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up. [ Time Frame: 12 months ]Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up.
- Changes of the patients with mRS NIHSS Barthel Index score [ Time Frame: 12 months ]Changes of the patients with mRS NIHSS Barthel Index score
- Postoperative patients with drug use [ Time Frame: 12 months ]Postoperative patients with drug use
- Patient survival after 12 months [ Time Frame: 12 months ]Patient survival after 12 months
- Patients hospitalized cost [ Time Frame: 5-7 days ]Patients hospitalized cost

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994187
Contact: Liqun Jiao, MD | 86-1083198899 ext 8836 | jiaoliqun@gmail.com | |
Contact: Yanfei Chen, MD | 86-1083198899 ext 8836 | chenyanflying@126.com |
China | |
Department of neurosurgery, Xuanwu hospital | Recruiting |
Beijing, China, 100053 | |
Contact: Jiao Li qun, MD 86-10-83198899 ext 8836 jiaoliqun@gmail.com |
Principal Investigator: | Feng Ling, MD | Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Xuanwu Hospital, Beijing |
ClinicalTrials.gov Identifier: | NCT01994187 |
Other Study ID Numbers: |
XW125-S004 |
First Posted: | November 25, 2013 Key Record Dates |
Last Update Posted: | November 25, 2013 |
Last Verified: | September 2013 |
Carotid stenosis Angioplasty Carotid endarterectomy Stroke |
Carotid Stenosis Constriction, Pathologic Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Pathological Conditions, Anatomical Carotid Artery Diseases Arterial Occlusive Diseases |