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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
Sponsor:
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing

Study Description
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Brief Summary:

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
Carotid Stenosis Surgery Stroke Procedure: Carotid endarterectomy Procedure: carotid angioplasty

Detailed Description:

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:

  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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Procedure: Carotid endarterectomy
Other Names:
  • conventional carotid endarterectomy
  • Eversion carotid endarterectomy

Procedure: carotid angioplasty
Other Name: carotid angioplasty with stent


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Success rate of any procedure (CAS or CEA) [ Time Frame: 1 days ]
    Success rate of any procedure (CAS or CEA)

  2. 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.

  3. To observe the rate of restenosis during follow-up. [ Time Frame: 12 months ]
    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. [ Time Frame: 12 months ]
    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 [ Time Frame: 12 months ]
    Changes of the patients with mRS NIHSS Barthel Index score

  6. Postoperative patients with drug use [ Time Frame: 12 months ]
    Postoperative patients with drug use

  7. Patient survival after 12 months [ Time Frame: 12 months ]
    Patient survival after 12 months

  8. Patients hospitalized cost [ Time Frame: 5-7 days ]
    Patients hospitalized cost


Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
one group:1050 cases of endarterectomy; the other group:1050 cases of carotid artery stent; totally:2100 cases of ravascularization for carotid stenosis
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Liqun Jiao, MD 86-1083198899 ext 8836 jiaoliqun@gmail.com
Contact: Yanfei Chen, MD 86-1083198899 ext 8836 chenyanflying@126.com

Locations
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China
Department of neurosurgery, Xuanwu hospital Recruiting
Beijing, China, 100053
Contact: Jiao Li qun, MD    86-10-83198899 ext 8836    jiaoliqun@gmail.com   
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
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Principal Investigator: Feng Ling, MD Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Xuanwu Hospital, Beijing:
Carotid stenosis
Angioplasty
Carotid endarterectomy
Stroke
Additional relevant MeSH terms:
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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