Aortic Aneurysm, Aortic Dissection, Stent-graft
Conditions
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.
Interventions
PROCEDUREAortic stent-graft
Early intervention with aortic stent-graft
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aortic aneurysm and death | 4 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Events and complications | 4 years | paraplegia cerebrovascular accident aorta surgery |
Countries
South Korea
Outcome results
None listed