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

Phase 4

Terminated

• Conditions: Aortic Dissection; Stent-graft; Aortic Aneurysm
• Interventions: Procedure: Aortic stent-graft

• Registration Number: NCT01354119
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-16
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early intervention	Aortic stent-graft	Early intervention: stent-graft just after acute phase

Primary Outcome Measures

Name	Time	Method
Aortic aneurysm and death	4 years

Secondary Outcome Measures

Name	Time	Method
Events and complications	4 years	paraplegia cerebrovascular accident aorta surgery

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of