Back to resultsLong-term Benefit of Aortic Stent-graft in Patients With Distal Aortic Dissection
Primary Purpose
Aortic Dissection, Aortic Aneurysm, Stent-graft
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aortic stent-graft
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Dissection
Eligibility Criteria
Inclusion Criteria:
- Uncomplicated distal aortic dissection
- Initial false lumen diameter >= 22 mm
Exclusion Criteria:
- Old age (> 75 years old)
- Other comorbidity or malignancy with life expectancy < 5 years
- Complicated dissection requiring aortic surgery or intervention
- Sudden death in acute phase
- Marfan syndrome
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Early intervention
Conservative
Arm Description
Early intervention: stent-graft just after acute phase
Conservative: medial follow-up without early intervention
Outcomes
Primary Outcome Measures
Aortic aneurysm and death
Secondary Outcome Measures
Events and complications
paraplegia cerebrovascular accident aorta surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01354119
Brief Title
Long-term Benefit of Aortic Stent-graft in Patients With Distal Aortic Dissection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
Not enough participants enrolled
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Aortic stent-graft is useful to occlude intimal tear and prevent further dilatation of the false lumen in patients with aortic dissection. The long-term benefit of aortic stent-graft in patients with uncomplicated distal aortic dissection has not been well demonstrated, especially in patients at high risk of aneurysmal change and death.
Purpose: The purpose of the study is to evaluate long-term clinical benefit of stent-graft insertion performed just after the acute phase into the descending thoracic aorta in patients with distal aortic dissection and at high risk of aneurysmal change of the dissected aorta.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Dissection, Aortic Aneurysm, Stent-graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early intervention
Arm Type
Active Comparator
Arm Description
Early intervention: stent-graft just after acute phase
Arm Title
Conservative
Arm Type
No Intervention
Arm Description
Conservative: medial follow-up without early intervention
Intervention Type
Procedure
Intervention Name(s)
Aortic stent-graft
Intervention Description
Early intervention with aortic stent-graft
Primary Outcome Measure Information:
Title
Aortic aneurysm and death
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Events and complications
Description
paraplegia cerebrovascular accident aorta surgery
Time Frame
4 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Uncomplicated distal aortic dissection
Initial false lumen diameter >= 22 mm
Exclusion Criteria:
Old age (> 75 years old)
Other comorbidity or malignancy with life expectancy < 5 years
Complicated dissection requiring aortic surgery or intervention
Sudden death in acute phase
Marfan syndrome
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Long-term Benefit of Aortic Stent-graft in Patients With Distal Aortic Dissection
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