A Multi-center Trial of Single-Branched Stent Graft System to Treat Aortic Dissection
NCT ID: NCT01914237
Last Updated: 2013-08-02
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
NA
70 participants
INTERVENTIONAL
2013-04-30
2017-04-30
Brief Summary
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Number of patients: 70 patients will be included and undertaken endovascular repair with Castor stent.
Follow-up: 1.aortic computed tomographic angiography (CTA) examination 6 and 12 months after the surgery 2.telephone or clinical follow-up 30 days and 2-5 years after the surgery
Primary Outcome Measure: success rate of endovascular repair for efficacy measurement.
Secondary Outcome Measure: 1 year stent related adverse event rate for safety measurement.
Other Outcome Measures:
1. efficacy:
* 1 year success rate of treatment
* 1 year patency rate of branch stent
2. safety:
* in-hospital mortality
* complication rate of neural system
* 1 year dissection or stent related mortality
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Castor Stent Graft
To study the safety and efficacy of Castor single-branched stent graft system in endovascular repair of aortic dissection.
Castor Stent Graft
Endovascular Repair of Aortic Dissection
Interventions
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Castor Stent Graft
Endovascular Repair of Aortic Dissection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diagnosed as aortic dissection
* proximal tear of the dissection locates between 15mm to the distal end of left common carotid artery and 20mm to the distal end of left subclavian artery (LSA) or inverse tear to LSA
* good compliance with the instructions and cooperate with follow-up
* voluntarily signed the informed consent form
Exclusion Criteria
* no appropriate vessel approaches
* patients with connective tissue diseases (such as Marfan syndrome)
* allergic to nitinol or contrast medium
* bad compliance with the instructions and follow-up
* estimated remaining life is less than 12 months
18 Years
80 Years
ALL
No
Sponsors
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Fudan University
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Central South University
OTHER
Beijing Anzhen Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Peking University People's Hospital
OTHER
Chinese PLA General Hospital
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Nanjing PLA General Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Shandong Provincial Hospital
OTHER_GOV
The First Affiliated Hospital of Zhengzhou University
OTHER
Xijing Hospital
OTHER
China Medical University, China
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
Changhai Hospital
OTHER
Responsible Party
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Zaiping JING
Director of Department of Vascular Surgery
Principal Investigators
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Zaiping JING, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Vascular Surgery, Changhai Hospital
Locations
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Department of Vascular Surgery, Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zaiping JING, MD
Role: primary
Other Identifiers
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Castor-2012-04
Identifier Type: -
Identifier Source: org_study_id