Long-term Benefit of Aortic Stent-graft in Patients With Distal Aortic Dissection

Asan Medical Center

Status and phase: Terminated; Phase 4

Conditions: Stent-graft; Aortic Aneurysm; Aortic Dissection

Treatments: Procedure: Aortic stent-graft

Study type: Interventional

Funder types: Other

Identifiers

NCT01354119

ADdistal_graft

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Early intervention

Active Comparator group

Description:

Early intervention: stent-graft just after acute phase

Treatment:

Procedure: Aortic stent-graft

Conservative

No Intervention group

Description:

Conservative: medial follow-up without early intervention