Revascularization of Extracranial Carotid Artery Stenosis
NCT ID: NCT01994187
Last Updated: 2013-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2100 participants
OBSERVATIONAL
2013-07-31
2015-06-30
Brief Summary
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Understand situation about the adverse events occurs after the revascularization (CAS and CEA), evaluate the health economics .
Detailed Description
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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:
1. The participants who suffer from stroke(ischemic or hemorrhagic), death or cardiovascular events within 30 days after any revascularization procedure.
2. 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:
1. Success rate of any procedure (CAS or CEA).
2. postoperative complications, including hyperperfusion syndrome,TIA, ipsilateral infarction, vascular dissection and other adverse events.
3. To observe the rate of restenosis during follow-up.
4. Stroke in patients with TIA mainly heart attacks and other cardiovascular events during follow-up.
5. Changes of the patients with mRS NIHSS Barthel Index score.
6. Postoperative patients with drug use.
7. Patient survival after 12 months.
8. 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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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
Carotid endarterectomy
carotid angioplasty
Interventions
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Carotid endarterectomy
carotid angioplasty
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria:the cases of carotid stenosis which received CEA or/and CAS in other hospital(not enroll this study) will be exclusion.
ALL
Yes
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Principal Investigators
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Feng Ling, MD
Role: PRINCIPAL_INVESTIGATOR
Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China
Locations
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Department of neurosurgery, Xuanwu hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Jiao Li qun, MD
Role: primary
References
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Yang B, Ma Y, Wang T, Chen Y, Wang Y, Zhao Z, Chen D, Wang J, Xu X, Luo T, Hua Y, Ling F, Qureshi AI, Hong B, Jiao L; RECAS Trial Investigators. Carotid Endarterectomy and Stenting in a Chinese Population: Safety Outcome of the Revascularization of Extracranial Carotid Artery Stenosis Trial. Transl Stroke Res. 2021 Apr;12(2):239-247. doi: 10.1007/s12975-020-00835-8. Epub 2020 Jul 19.
Other Identifiers
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XW125-S004
Identifier Type: -
Identifier Source: org_study_id