Status:
UNKNOWN
A Multi-center Trial of Single-Branched Stent Graft System to Treat Aortic Dissection
Lead Sponsor:
Changhai Hospital
Collaborating Sponsors:
Fudan University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Distal Aortic Dissection
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Aim:Castor is a novel single-branched stent graft system for endovascular repair of aortic arch dissection. This is a prospective, one-arm, open, multi-center, pre-market study of Castor stent to eval...
Eligibility Criteria
Inclusion
- age from 18 to 80, male or unpregnant female
- 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
- Pregnant female
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2017
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01914237
Start Date
April 1 2013
End Date
April 1 2017
Last Update
August 2 2013
Active Locations (1)
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1
Department of Vascular Surgery, Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433